How does kidney dialysis affect the body?

What do kidneys do?

The kidneys, two fist-sized organs located on either side of the spine, perform a life-sustaining role in the body— removing toxins from the body, regulating fluids and preventing excessive buildup, regulating blood pressure, stabilizing blood/mineral balance, and maintaining vitamin B balance. Essentially acting as filters, kidneys cleanse about 200 quarts of fluid in the body every 24 hours.

What happens if kidneys don’t do their job?

Kidney failure occurs when your kidneys can no longer filter waste effectively, resulting in an overload of toxins in the body. Symptoms include urinating (removing waste) less frequently, swelling from retention of fluids (water waste), fatigue, and nausea.

One treatment option for kidney failure is dialysis—using a machine to perform the function of the kidneys by purifying the blood and eliminating waste. While dialysis isn’t a cure for kidney failure, it can help to keep fluids and electrolytes balanced.

How does dialysis work?

There are three types of dialysis: hemodialysis, peritoneal dialysis, and continuous renal replacement therapy.

Hemodialysis is the most common type of dialysis, which uses an artificial kidney to perform the job function of the failing kidney. This includes surgery in which an entry point is created to the blood vessels so the blood can flow to the artificial kidney.

Peritoneal dialysis also involves surgery and uses the abdomen lining (peritoneum) and a cleaning solution (dialysate) to purify the blood. This process involves a catheter and must be repeated four to six times per day. This can be done manually or with a machine.

Continuous renal replacement therapy is used to treat critically ill patients, primarily those with acute kidney failure. This is performed 12 to 24 hours per day, generally in the intensive care unit.

What are the side effects of dialysis?

Unfortunately, this life-saving procedure may come with some uncomfortable side effects including low blood pressure (when too much fluid is added or removed), nausea, dry and itchy skin (due to the phosphorus and potassium in the body), restless leg syndrome (due to vitamin B deficiency), and muscle cramps (from excessive or quick loss of fluid in the body).

Fluid overload occurs when there is too much fluid build-up in the body during dialysis, as the kidneys are no longer able to remove enough on their own. This can result in additional swelling, bloating, cramping, high blood pressure, shortness of breath and heart problems. For this reason, the patient must limit the amount of sodium and fluid they consume between dialysis treatments.

Fortunately, there are ways to avoid the discomfort—fluid guidelines, additional medical assistance, lifestyle changes or even dialysis adjustment can help to alleviate the side effects.

Volunteering with OCRC

If you are interested in getting involved in kidney-related clinical research, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.

You can also contact us to inquire about additional current research volunteer opportunities.

What Do You Need to Know About Clinical Trials?

The overarching goal of clinical studies is to determine whether existing medical treatments can be modified for increased effectiveness, and/or whether new medical advancements are more effective than standard treatments. In order to address the complexities of these questions, it is important for all prospective participants to understand these important aspects of clinical trials.

Understand Participant Qualifications

Researchers analyze volunteer data to determine whether a new treatment is viable.

Patient eligibility is based on specific qualifications and criteria that vary depending on the study’s protocol. Inclusionary and exclusionary criteria can include age, gender, diagnosis, medical history, family history, prior treatments, and even family history.

Through four study phases, researchers closely examine a treatment’s side effects and effectiveness in volunteer groups ranging from 20 to 3,000 volunteers. All participants should be aware of the possibility of receiving a placebo, which is commonly a sugar pill or a harmless, ineffective medication. Usually, one group of volunteers is given a placebo in place of an experimental medication in order to evaluate the therapy’s effectiveness.

After the FDA reviews and approves the experimental medication, the treatment will continue to be studied and modified accordingly on a long-term basis. Many studies never reach the FDA approval stage because the medication is determined to be medically ineffective, and thus not beneficial to the human population.

All Clinical Study Volunteers Have Rights

The decision to participate in a clinical study is one that should be taken seriously and discussed with your doctor. Participants should also be aware of their rights as a clinical study volunteer. This includes the right to informed consent through the Patient Bill of Rights.

A volunteer always has the right to information, meaning they should always be provided with answers to the following questions:

  • What is the purpose of the study?
  • How will I receive the treatment?
  • Does this treatment involve a placebo?
  • What are the possible side effects?
  • Will there be follow-up treatments after the trial is completed?

Participants maintain the right to withdraw from a study at any point but should first discuss this decision with a doctor in order to fully understand the potential consequences of forgoing the full trial in its entirety.

Weigh Study Benefits and Risks

While there are benefits and risks associated with all clinical trials, it’s important to note that key thought leaders greatly support clinical study participation. “We believe very strongly in clinical trials as an option for our patients,” says Pamela Crilley, DO, Chair of the Department of Medical Oncology at Cancer Treatment Centers of America. “We’ve learned many of the things that are now standard of care from clinical trials, and I believe that is important to see if there are any potential clinical trials for a patient.” For many study volunteers, they feel the upsides outweigh any potential concerns.

Volunteering for a clinical trial offers several benefits, including:

  • Access to treatment that would not otherwise have been available
  • Support from a team of experts and closely monitored progress
  • Knowledge that participation in a future clinical trial will help more people

However, the risks must also be taken into careful consideration:

  • Unexpected side effects
  • Ineffective treatment
  • Loss of time and energy

Learn More About Clinical Trials

You can review our Guide to Understanding Clinical Research Languageto understand common clinical research terminology. You can also contact us to inquire about current volunteer opportunities, our methodologies and any questions pertaining to the clinical study process.

How Does Clinical Research Lead to New Scientific Breakthroughs?

In the mid-1700s, physician James Lind conducted the first controlled clinical trial in order to find a cure for sailors suffering from scurvy. Through his research, he discovered that citrus fruits such as oranges and lemons were able to remedy the disease caused by Vitamin C deficiency.

In 1928, Alexander Fleming conducted a series of experiments involving common bacteria; an uncovered Petri dish became contaminated with mold, the “juice” of which he found to kill off harmful bacteria of several common diseases including scarlet fever and pneumonia. This “mold juice” would later be named penicillin. In the word of Fleming, “when I woke up… I certainly didn’t plan to revolutionize all medicine by discovering the world’s first antibiotic, or bacteria killer. But I suppose that is exactly what I did.” Little did Fleming know his “mold juice” would change the world for the better.

In 1955, after years of research, Dr. Jonas Salk announced his own major medical breakthrough—the discovery of a vaccine that could prevent polio. As recently as August 2017, there continue to be major developments in cancer research, with several new studies being conducted at this very moment.

These breakthroughs are only possible through the research done in clinical trials— in fact, there is a direct correlation between clinical trials and major medical breakthroughs. In addition to treating and preventing diseases and viruses, it’s also crucial that clinical researchers and principal investigators understand these diseases and keep them under control. Even with the advances of modern science and medicine, however, nothing quite beats the old-fashioned “trial and error” method.

How are new clinical trials chosen?

Clinical trials can be conducted on a priority basis. For example, a vaccine was urgently needed after the recent Zika outbreak. As of December 2017, several Phase I trials showed promising results. 

Sponsors also play a role in the development of a clinical study. They may initiate, manage or finance a clinical trial, but will not conduct the study or collect research. A sponsor may be an institution where the trial is held, or a company/organization with a mission to support efforts within a specific area of research. Johnson & Johnson’s pharmaceutical products focus on the areas of immunology and infectious diseases, among others; in 2016, they sponsored 100 trials including a Phase III trial for an Ebola vaccine.

Clinical studies can also be chosen based on patient population. According to Douglas Weckstein, MD, trials are often identified if they are believed to offer patients a promising chance of benefit, or if they will answer important questions that will improve patient care in the long run. The goal is essentially to offer treatment options to patients that they would not otherwise be able to obtain. Inclusion and exclusion criteria of the study is also a factor in determining any limitations within the participant population.

Ongoing Research & Development

Several clinical studies are conducted as a way to continuously improve existing treatment methods and further understand the disease. Ongoing research and development methods have allowed HIV patients better qualities of life compared to just 25 years ago. According to the American Diabetes Association, one in three Americans will develop diabetes by the year 2050 if current rates continue. For this reason, researchers are continuously working to develop new treatment and prevention methods.

How Can I Participate in Clinical Trials?

ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Additionally, your own doctor and/or community hospital may be involved in clinical trials. You can always contact us to inquire about current research volunteer opportunities.

Who Oversees Clinical Trials?

Clinical trials are carefully conducted studies—using human volunteers—which are used to test potential medical treatments with an end goal of receiving an FDA approval for usages in a wider population. Any and all medical breakthroughs currently being used have, at some point, gone through the close observation during the clinical trial phases process. Because these treatments are being used on real subjects, it is important that these clinical trials are conducted in safe, ethical ways.

What are clinical trial regulations?

Before clinical research ensues, it must first be approved by an institutional review board (IRB). When conducting clinical trials, researchers should maintain communication with their study participants. Before volunteering to participate in a clinical trial, be sure that you are able to answer all of the important questions and that you know exactly what to expect. These should be laid out clearly in an informed consent form, which includes a summary of the clinical trial, treatment procedures and schedules, and risks and benefits. It will also lay out all of your rights as a volunteer, including the right to leave the study at any time.

How are clinical trial regulations enforced?

A Data Safety Monitoring Board (DSMB), which is a group of research and study topic experts, is required for all National Institutes of Health phase III clinical trials, in addition to earlier phase trials which involve more high-risk treatments. The DSMB reviews clinical trial data for any safety issues or differences in results among certain groups. Some trials may also be stopped early by the DSMB if they are causing harmful effects or revealing patient risks.

What is a Principal Investigator?

A Principal Investigator (PI) is the person in charge of conducting a clinical trial. The PI is responsible for ensuring that the study is following all regulatory requirements and meeting the international recognized standards for Good Clinical Practice (GCP). The PI is also responsible for making sure that all volunteers receive appropriate medical care related to the clinical trial.

What does it take for a study to become FDA-approved?

Before beginning a clinical trial, researchers must first submit an Investigational New Drug (IND) application to the FDA. This application should include data about side effects that may cause harm, manufacturing information, clinical protocols, and any prior human research data.

The FDA may be involved at any point in the drug development process—before completing an IND application, during the study (for guidance), and after the study to assess results. Developers may ask for help at any time, but are not required to take the FDA’s advice.   FDA-approval of the medical treatment itself takes place within a structured framework including analysis of target condition and currently available treatments, evaluation of benefits and risks from clinical research, and strategies for managing risks.  How can I learn more?

ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Additionally, your own doctor and/or community hospital may be involved in clinical trials. You can always contact us to inquire about current research volunteer opportunities.

Recent Developments in Cancer Research

Looking back at the impressive progress of medical advancements, clinical trials have played a critical role in the current status of modern medical treatments. Clinical studies have also been a catalyst for the modification and improvement of previously existing therapies. 

In 2014, nearly 14.5 million people in the United States were living with a cancer diagnosis. However, that number is expected to rise to almost 19 million by the year 2024. The number of deaths caused by cancer, however, has decreased significantly—especially since the early 1990s. Much of this progress is thanks to the incredible medications that are now available. 

How Have Clinical Trials Affected Cancer Research?

  1. Leukemia Treatment

As recently as August 2017, clinical trials led to the FDA-approval of Kymriah, a cell-based gene therapy for pediatric and young adult forms of acute lymphoblastic leukemia. According to Peter Marks, M.D., Ph.D, Director of the FDA’s Center for Biologics Evaluation and Research, “Kymriah is a first-of-its-kind treatment approach that fills an unmet need for children and young adults with this serious disease… [it] has shown promising remission and survival rates in clinical trials.”

  1. Lung Cancer Progress

In 2016, clinical study results showed that Keytruda improved side effects and extended survival lengths of patients with advanced non-small cell lung cancer. 2016 also provided the first new development in bladder cancer treatment in 30 years, after a clinical trial comparing tumor shrinkage in patients. 

  1. Bladder Cancer and Multiple Myeloma Advancements

In one year alone—November 2015 to October 2016—the FDA approved eight new cancer treatments, including immunotherapies for bladder cancer and multiple myeloma. The new approvals also included treatments for forms of lung and kidney cancers, chronic lymphocytic leukemia, and multiple myeloma.

  1. Future Developments

In addition to these new FDA-approved treatments, clinical trials within that same time frame were used to implement new uses of 12 previously existing treatment methods. These have broadened treatment options for patients with melanoma, sarcoma, chronic lymphocytic leukemia, lymphoma, neuroendocrine tumors, and breast, lung, kidney, head and neck cancers.

Other recent developments include (and are not limited to):

Who Participates in Clinical Trials?

Without medical researchers’ oversight during clinical studies, the development of these new treatments would have been virtually impossible. While the number of registered studies has increased from just under 4,000 in the year 2000 to 263,269 as of January 2018, only about 3% of adult cancer patients participate in clinical trials. This means that the other 97% of adult cancer patients could potentially benefit from new medical advancements.

Why Should I Participate in Clinical Trials?

By participating in clinical studies, you are playing a part in something that could potentially save lives or prevent illnesses. Remember: all medical treatments started as clinical studies! 

How Can I Participate in Clinical Trials?

ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Additionally, your own doctor and/or community hospital may be involved in clinical trials. You can always contact us to inquire about current research volunteer opportunities.

What Is the Placebo Effect?

“I’m a Cub Scout Camp Leader. When the kids start crying and want to go home, we just give them ‘homesick medicine’,” reads a submission on PlaceboArchive.org. “The kids always feel better within 15 minutes. The medicine is Tic-Tacs.”

“I was cutting onions one day, appreciating my contact lenses as they keep me from tearing up,” reads another submission. “After about a minute, I realized that I didn’t have my contact lenses in… I started tearing up within five seconds.”

The Power of the Mind

Our minds can do incredible things—they can even influence the ways our bodies respond to different situations. Similar to the above situations, many of us have likely experienced everyday examples of placebos: anything that seems to be a medical treatment, but isn’t. This phenomenon, called the “placebo effect,” is a significant part of clinical research.

While there are as many types of placebos as there are methods of medication, what all placebos share in common is that they do not contain any substances which affect health or wellbeing. In fact, many placebo pills are simply composed of sugar.

Why Use Placebos in Clinical Research?

Placebos, often used in studies of medical treatments, are used in clinical research as a controlled variable to test the effectiveness of said treatments. Volunteers in clinical trials will often be divided into groups; one group would receive the treatment in question, and the other would receive a fake treatment—the placebo—without knowing which one they are receiving. Researchers can then accurately compare the results of the experimental drug with the results of the placebo. If they both have the same reaction, this generally means that the drug is not effective.

The Placebo Effect
Ideally, volunteers in clinical trials would have no response to placebos, thus being able to determine the effectiveness of a studied drug with full accuracy. However, people can—and often do—have responses to placebos. One theory is that the placebo effect occurs because of a person’s expectations. If a volunteer in a clinical trial believes they are receiving a studied drug, they will likely expect the drug to do something. That person’s body will then be influenced to create similar effects to that of the actual drug.

The Placebo Effect: Helpful or Harmful?

For years, the placebo effect was considered to be an obstacle to overcome in clinical research. However, attitudes have evolved and researchers are looking into ways to utilize the placebo effect to its fullest potential. While the placebo effect may not speak directly to the effectiveness of a studied drug, it does speak to the complexity of our brain and body chemistry; the expectations which cause the placebo effect may involve genuine changes in brain chemistry, which cause a physiological reaction.

The placebo effect has opened doors to further research on the brain: if expectations of a medication can cause both positive and negative physical reactions, what else can our brains do?

Learn More About Clinical Studies

ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Additionally, your own doctor and/or community hospital may be involved in clinical trials. You can always contact us to inquire about current research volunteer opportunities.

A Day in the Life of a Clinical Study Participant

Clinical trials are vital to the medical advancement process and to the development of new treatments. Clinical research participants get to play an active role in the development of modern medicine and health care. Incredibly, an experimental, life-saving treatment administered to a volunteer could one day be consumed by millions of Americans.

Take a deeper look into the clinical trial experience with our in-depth explanation of what goes into study participation.

What does it mean to be a clinical study participant?

Clinical studies are conducted with human volunteers in order to analyze the effectiveness of experimental new treatments. The study participants will receive medical care at health facilities for the duration of the trial and will receive access to new medical treatments before they are widely available to the public.

The number of desired volunteers and the length of the trial depends largely on the phase of the clinical study—this could be for weeks, months, or even years. Study organizers will always disclose this information upfront, as volunteers must be available for the duration of the time period.

What kind of clinical studies can I participate in?

Any health care treatments and medications you have heard of came to fruition after extensive research through clinical studies. This means that clinical trials cover a wide range of topics:

  • Intervention studies: Are there better treatment methods than those currently available?
  • Prevention studies: How can certain diseases and conditions be prevented?
  • Diagnostic and screening studies: Are there more effective ways to diagnose diseases?
  • Behavioral research: Which behavioral traits are related to a specific diagnosis?
  • Quality of life studies: How can the quality of life of those diagnoses with diseases/medical conditions be improved?
  • Observational studies: How can the health of individuals change over time?

Each study has different guidelines and eligibility requirements. If you are interested in joining a specific study, you must first find out if you meet the “inclusion criteria,” or factors that allow participation in the study. Some studies require healthy participants, while others seek those with specific diseases and/or medical conditions.

How does participating in clinical studies affect day-to-day life?

Because clinical study topics range so vastly, day-to-day protocol is also unique to each study. Before joining a study, make sure you are well-informed, and that you have asked yourself the following questions:

  • What are the possible risks involved?
  • What are the possible side effects? How severe are they?
  • How much time and energy would be spent with complex dosage schedules and/or frequent trips to the study site?

What do other clinical study participants think of their experiences?

According to Forte Research, only about 10% of Americans have participated in clinical studies. While about 95% of those clinical study participants said they would consider participating in another clinical study in the future, only about 88% of participants talk about their experience after the study concludes.

It’s possible that this is due to lack of public appreciation, a desire to keep health issues private, or a lack of immediate study visibility (as it often takes years for clinical research results to become public) resulting in a loss of interest. 

What is HIPAA?

HIPAA, or the Health Insurance Portability and Accountability Act, is a law designed to protect patient and participant privacy pertaining to medical records and other health information.

How can I get started?

If you’re interested in a clinical study, please tell us a little more about yourself in the Contact section of our home page and we will respond to you to determine your eligibility for current and future studies.

You can also visit ClinicalTrials.gov and CenterWatch.com for clinical trial information in different locations across the country. Additionally, your doctor and/or community hospital may be involved in clinical trials and can advise you on which one may be the right fit for you.

Clinical Research FAQ

Clinical Research FAQ 

If you are new to the world of clinical trials, the terminology and procedures can be unfamiliar and even intimidating. The good news is that every medication that undergoes a clinical trial has been shown to be safe during extensive testing in preclinical trials (animal studies) To further explain the clinical research process, we’ve assembled some simple questions and answers to walk you through how it works.

What are clinical trials?

Clinical trials are studies conducted by clinical researchers in order to advance medical knowledge and develop new treatments/medications. Clinical trials, or research conducted through human volunteers, explore a variety of topics ranging from the use of daily vitamins to cancer treatments.  

How long are clinical trials?

The length of a clinical study varies according to what is being studied—this could range from several weeks to several years. Depending on the phase of the study, a participant may or may not be part of the entire study. Participants will always be informed of length of the study and ideal participation time prior to enrolling.

What are the benefits and risks of participating in clinical trials?

Advances in medical technology would be impossible without clinical trials; clinical trials are impossible without volunteers. Participating in a clinical trial can make you part of a process that will help to improve the health of millions.

Before enrolling in a clinical trial, potential participants are evaluated to ensure that they meet the volunteer requirements (age, gender, location, medical history, etc.). They should also discuss clinical trial involvement with their usual health care provider to make sure there will be no conflicts with ongoing medications or treatments.

Is there compensation?

Whether or not you get paid—and the amount you receive—for participating in clinical trials depends on the study being conducted. Factors include participant’s time and energy spent on the trial, amount of traveling associated and the phase of the study. Rates are generally determined by the study’s principal investigator 

What are my rights as a clinical trial participant?

Informed consent is a process used by researchers to communicate with potential participants about the study. This also provides participants with all necessary information, ensuring that the participant understands what the trial entails, and stresses that participation is always voluntary.

If you are thinking of joining a clinical trial, it doesn’t hurt to take the time to get answers to some important questions.  

What is a placebo?

Placebos are harmless, inactive “medications” that are sometimes used in place of the real medication. Participants aren’t told whether the treatment they are using is a placebo or not—this is to maintain consistency with the control and dependent factors by preventing bias or imagined results on behalf of the participant.

What is randomization?

Randomization is when treatments are selected by chance, not choice, in order to prevent the results from being skewed. If the researcher or participant is allowed to choose who receives a new treatment, the results may be influenced, subconsciously or not. Randomization reduces the occurrence of bias; without it, a doctor may inadvertently choose a patient that they think is more likely to benefit from the treatment. 

Where can I find clinical studies?

ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Additionally, your own doctor and/or community hospital may be involved in clinical trials. You can always contact us to inquire about current research volunteer opportunities.

How Does Clinical Research Help Find Cures?

Spanning more than 200 countries and 50 states, clinical trials explore new, experimental therapies and medicinal treatments that will impact medicine for centuries to come. These treatments can range from new standard pill capsules to medical devices, from vaccines to blood products or gene therapies, and even behavioral or surgical procedures; but, every study Improves researcher’s understanding of the way drug therapies affect common ailments.

Some of the exciting breakthroughs that researchers are currently working on include:

  1. A new drug to treat Parkinson’s disease emerged in the medical world earlier this year after a clinical trial conducted by Newron Pharmaceuticals;
  2. A cancer treatment was recently approved after being produced by Novartis Pharmaceuticals;
  3. Studies are being conducted for slowing down and treating Alzheimer’s disease;
  4. Science backing the usage of daily vitamins and dietary supplements to prevent or slow illness would not exist without clinical trials.

But in order to conduct groundbreaking research, clinical researchers must first go through a lengthy process before study participants even enter the equation.

Preclinical Treatments

Before beginning clinical research among humans, drug developers must first conduct preclinical treatments either in a lab or with animals—in vitro or in vivo. They must then submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).

The IND must include, but is not limited to, data from the preclinical trials and specific protocol for the study in question including volunteer selection criteria, length of study and whether there will be a control group. It is only after preclinical treatments, IND application approval, carefully monitored clinical trials and submission of a New Drug Application (NDA) that new medical treatments can be approved by the FDA.

Clinical trials are conducted in an attempt to answer questions about potential drug development:

  • How is it absorbed/distributed/metabolized/excreted?
  • What are the potential benefits and/or side effects?
  • What is the best dosage and usage method?
  • How are people of different groups (race, gender, age, etc.) affected?
  • How does it interact with other drugs or treatments?
  • How does it compare to similar drugs?  

Study Length

The duration of a clinical trial can range from several weeks to several years. Once a study is completed, it will take even more time to analyze the data and summarize the results, often in an academic or medical journal.

Many studies listed on ClinicalTrials.gov will include a summary of results within a year of the study’s completion. Even if the results did not quite meet the goals of the researchers, it is important to continuously share the results in order to keep researchers asking questions and moving forward in the research process.  

Significant breakthroughs in medical research have only been possible because of the participation of volunteer participation—healthy and unhealthy—in clinical trials.

Learn More About Clinical Research

ClinicalTrials.gov and CenterWatch.com are just two resources for finding clinical trials that are actively recruiting participants. Additionally, you can ask your own doctor or community hospital if they are involved in clinical trials, or check out the website of an organization focused on a specific disease or disability.

OCRC offers opportunities to become involved in clinical trials and research study, which can be found on our Current Studies page. You can always contact us to inquire further about volunteer opportunities.

How to Become a Clinical Researcher

Medical research is continuously underway and the results enable researchers to further understand the complexities of pathogens and develop effective new vaccinations. While many individuals can participate in clinical trials as volunteers, the qualifications needed to work as a clinical researcher are, understandably, much more extensive.

What is a clinical researcher?

Clinical researchers are responsible for conducting clinical trials, recruiting and screening patients, maintaining patient care and submitting findings upon completion of the trial. Throughout the trial, they must ensure ethical and proper clinical practice, following and enforcing strict rules and regulations.

According to Learn.org, “you will spend long periods of time in laboratories conducting experimentation and cataloging, analyzing and publishing your results. In contrast to physicians, clinical researchers generally work regular hours. Your research will likely address human health issues, and may culminate in significant medical innovation.”

There are several different types of clinical research:

  • Treatment research
  • Prevention research
  • Diagnostic research
  • Screening research
  • Quality of life research
  • Genetic studies
  • Epidemiological studies (seeking patterns and causes of diseases and disorders)

Within these branches, there are a variety of positions. Those in the clinical research field can work in universities, hospitals, pharmaceutical companies or government positions. They can work with data in an office environment, administer trial drugs and therapies alongside patients or instruct physicians, residents and technicians about proper clinical procedures.

Two roles that are essential (and can work as stepping stones to further a career in clinical research) are the Clinical Trial Assistant (CTA) and Clinical Research Coordinator (CRC) positions. The CTA typically works in an office-based environment, where they track and file trial protocols and case reports, coordinate meetings and help with managing timelines and budgets; the CRC typically recruits patients, works at the research site, prepares the case report forms and manages data.

Education

A career in clinical research typically begins during undergraduate studies, with a four-year bachelor’s degree in a field related to biology, mathematics or physics. A strong academic record is important, as medical and doctoral programs are quite competitive. Depending on which path you decide to take after exposure to the field in your undergraduate studies, you may then go on to pursue a master’s degree, or even an M.D. or a Ph.D. Relevant degree fields include biological sciences or medicine—biochemistry, cellular and molecular biology, microbiology, neuroscience, M.D. or nursing. Some universities also offer master’s degrees specifically in clinical research.

Training

If you complete all of the required education, licensure is not required. However, there is an optional certification available from the Association of Clinical Research Professionals. Internships will likely be required, which can lead to an entry-level position as a clinical research associate (CTA or CRC).

According to Study.com, key skills of a clinical researcher include the ability to use analytical, scientific, database user interface and graphics software, extensive knowledge of other electronic equipment as well as centrifuges, laboratory flasks, petri plates, etc. While there is a lot of variety within the field, you must also have an eye for detail, appreciate strict guidelines, be well organized, enjoy solitary work and potentially spend a lot of time traveling, as stated by ClinicalResearchAssociated.com. 

Learn More About Clinical Research

At OCRC, we offer a variety of clinical trials and research studies that are open for participation,  in our state-of-the-art clinical research facility. If you are interested in volunteering, please tell us a little more about yourself in the Current studies section of the home page and we will contact you to determine your eligibility for current and future studies.

How Do The Kidneys Work?

How Do The Kidneys Work?

At just 4.5” inches, it’s hard to believe the kidneys cleanse upwards of 150 quarts of fluid from your body every day. It can be easy to overlook the importance of kidneys until their wellbeing is in jeopardy, but they are essential to healthy bodily functions. Read on to learn more about the kidney’s role in the endocrine and urinary system and the ways in which they purify your blood.

What Do the Kidneys Do?

The kidneys play a vital role in the human body. These fist-sized organs, located on either side of the abdomen, provide the human body with a unique filtration process to purify blood and remove waste. Proper kidney functionality is imperative to good health, mobility and longevity.

The Kidneys serve several purposes:

  • Regulate blood pressure by releasing a hormone called angiotensin
  • Remove toxins from the body
  • Ensure a stable blood mineral balance
  • Regulate fluids in the body and prevent excessive buildup
  • Filter blood and create red blood cells
  • Maintain vitamin B balance for healthy bones

How Do the Kidneys Work?

The kidneys receive a supply of blood from the renal artery, remove impurities from the blood, and then return the blood to the body through the renal vein. The kidneys remove toxins and unnecessary waste by means of urine, which travels from the kidneys to the bladder.

The human body absorbs whatever food nutrients it needs for energy and self-repair. According to WebMD, “After your body has taken what it needs from the food, waste is sent to the blood. If your kidneys did not remove these wastes, the wastes would build up in the blood and damage your body.”

Kidney Composition

Kidneys are comprised of different parts and tissues. One critically important part is called a nephron. There are more than one million nephrons in each kidney that all work together to remove waste and impurities from the body. Each nephron filters a small amount of blood, which is why there are so many of them within the kidneys.

According to NewHealthAdvisor.com, “There are two types of nephrons. The cortical nephrons, which make up about 85 percent, are found deep in the renal cortex, while the juxtamedullary nephrons, which make up about 15 percent of total nephrons, lie close to the medulla.”

The Impressive Power of the Kidneys

According to the National Kidney Foundation:

  • The kidneys filter about 150-200 quarts of fluid every 24 hours and return it to the bloodstream;
  • Approximately “two quarts are removed from the body in the form of urine, and about 198 quarts are recovered;”
  • Kidneys are under five inches, making them smaller than a computer mouse or a cell phone.

Learn More About Kidney Disease 

At OCRC, we are working to help create a better future for those impacted by chronic kidney disease. We are currently in need of volunteers for our Kidney disease study.

Volunteer qualifications include:

  • Ranging in age between 18-80
  • Presently have kidney impairment or disease

Currently seeing a nephrologist and taking medicine such as Procrit® or Epogen® for low blood count, Aranesp® for anemia, or PhosLo® or Renagel® for high blood phosphorus.

If you are interested in participating, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.

What is the Drug Development Process?

What is the Drug Development Process?

Americans spend more money on pharmaceuticals than neighboring Canada and Mexico, more than 20 European countries; and Japan, Korea and New Zealand. Billions of dollars are spent well before your medicine hits the pharmacy shelf – but where does all that money go? Read on to learn more about the drug development process and the work that goes into medicinal therapeutics.

Initial Development and Discovery

During this step, researchers focus on finding innovative new therapies through extensive testing and research. They begin with sometimes thousands of different options and whittle their way down to a few final options for further development. 

Once researchers have selected a unique compound mixture, they can begin to analyze the drug’s dosage, potency and side effects. Additionally, they look at the best methods of consuming or injecting the investigational drug, and its effectiveness compared to similar medications.

Preclinical Research

Before human testing can begin, researchers first must determine the toxicity of an investigational drug. Typically, mice or other small animals are utilized, depending on which animal has the most similar physical characteristics to humans. Once researchers have determined that an investigational drug is non-toxic for humans, they will recruit a small group of volunteers for initial testing.

Clinical Research

There are four different phases of clinical research. These phases correspond to the overall length of study, patient volume and complexity of the research plan. As an investigational drug moves through the process, the overall volunteer group size exponentially increases, which is a significant reason why certain phases may take years to complete.

The key objectives are to:

  1. Establish whether a medical product or device is safe for humans;
  2. Examine the way humans break down the experimental drug;
  3. Investigate the drug’s effectiveness and confirm which dosage is most effective;
  4. Determine which segments of the population experience the highest success rate;
  5. Identify any noted or potential side effects.

Many times, researchers will evaluate the wellbeing of a group of volunteers who receive an experimental medication against a “control group” who received a placebo (an inactive drug or substance that looks like the active drug). This is done to ensure statistically valid data and to help rule out alternative explanations for study results.

FDA Review

The Food and Drug Administration (FDA) has been reviewing drugs for over 100 years and just 10% of all drugs that start clinical trials will result in an approved drug. Their review process for all new medications is comprehensive and rigorous.

The FDA is ultimately the gatekeeper of the approval process. They oversee the drug development process and their policies and regulations impact every pharmaceutical company, clinical research and study volunteer in the industry. Learn more about the role of the FDA here.

Postmarket Studies

Post-marketing surveillance occurs after an experimental drug has been approved. These studies provide manufacturer’s with an opportunity to more closely examine the medication’s long-term side effects. Additionally, manufacturer’s may gain further insight into the long-term benefits of the treatment in a much larger patient population size, and the medication’s comparison against other treatments currently on the market.

Learn More About Clinical Trials

ClinicalTrials.gov, the FDA website and our blog catalog are all provide helpful information about clinical studies. Our staff at OCRC is also happy to offer tours at our state-of-the-art clinic to volunteers who meet study criteria.

At OCRC, we explain our methodology to every participant and we pride ourselves on the policies we put into place to keep everyone safe — both our staff, and study volunteers. The Phase I-IV clinical trials that we specialize in test investigational medications being developed by pharmaceutical and biotech companies. All participants receive free treatments and medical care related to the trial. Additionally, participants may be compensated for time and travel. Health insurance is never a requirement.

If you are interested in volunteering, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.

What Causes Kidney Disease?

What Causes Kidney Disease?

Approximately 26 million Americans live with kidney disease, without their conscious knowledge of the condition. Additionally, one in every three Americans are at risk for developing kidney disease. Many individuals overlook the symptoms of kidney disease because the signs are nonspecific and similar to other illnesses. High-risk individuals must have regular screenings, but anyone can have kidney damage without their knowledge.

A look at the underlying causes of kidney disease

The two leading causes of kidney disease have historically been high blood pressure and adult onset diabetes. However, recent research has indicated that acid reflux may result in a 20-50% increase for the development of kidney disease.

The treatment of Acid reflux, or heartburn caused by indigestion, involves preventative medications like Prilosec® (omeprazole), Nexium® (esomeprazole), or Prevacid® (lansoprazole). According to researchers at Johns Hopkins University, people who took two daily doses of these medications “had a higher risk compared to once daily dose users.”

Additionally, when certain medications are consumed over an extended time period, they can have a damaging effect on organs like the kidneys. Even common over-the-counter remedies like antacids or pain killers like ibuprofen can actually damage the kidneys when consumed excessively.

Kidney disease contributes to a number of chronic health concerns

Poor kidney functionality can cause a wide range of chronic illnesses. Here are some of the more common conditions associated with kidney damage and disease:

  • Heart disease: The leading cause of death of both men and women in the United States, heart disease symptoms include diseased vessels, structural problems, and blood clots. It results after the buildup of plaque in the arteries, which thickens and stiffens the walls of the organs and surrounding tissues.
  • Kidney failure: The final stage of chronic kidney disease, this condition exists when kidneys can no longer support the body’s needs. Once approximately 10-15% of kidney function remains, doctors may recommend dialysis or an organ transplant.
  • End Stage Renal Disease: After normal kidney function has been compromised, kidney disease results. Chronic kidney disease may lead to renal failure, or ESRD. This condition is very serious. According to healthline.com, “Without treatment, you may only be able to survive without your kidneys for a few months”
  • Bone disease: This condition may develop when certain substances, such as calcium, phosphate or vitamin D build-up within the body.
  • Anemia: Pale skin, weakness and chronic fatigue are commonly occurring side effects of this condition; which results when the body experiences a deficiency of erythropoietin, the hormone necessary to make new red blood cells.

Take preventative measures to avoid kidney damage

Keeping your body in overall good health is very important in the prevention of kidney damage. Like the old adage goes, “be good to your body and your body will be good to you!” Additionally, the following recommendations will help ensure the kidneys remain healthy well into old age:

  • Keep high blood pressure in check: Normal blood pressure helps ensure the kidneys are healthy and functioning normally. When blood pressure increases beyond what is considered healthy, the kidneys are forced to work harder and over time, the organs become less efficient at cleansing the body.
  • Monitor your cholesterol levels: Weight, diet, gender, alcohol use, stress levels and background are all factors in the development of high cholesterol. Exercising regularly and healthy eating habits are the best ways to prevent high cholesterol levels. Liver, thyroid and kidney health may also affect cholesterol levels.
  • Cease tobacco usage: Smoking or tobacco usage can cause a number of avoidable health problems like certain cancers, atherosclerosis, high blood pressure, and heart disease.
  • Stay at a healthy weight: Maintaining a healthy weight will help you avoid diseases like diabetes, high blood pressure and heart disease.
  • For more information about kidney disease prevention, visit our blog here and learn about the science behind kidney functionality and nephrology.

5 Ways to Give Back to Your Community this Holiday Season

5 Ways to Give Back to Your Community this Holiday Season

With so many errands to run and presents to track down, it can be easy to overlook the spirit of the holidays. It’s important to spread joy and show your loved ones how much you care; but, don’t forget to take time for those who are less fortunate and unable to provide for themselves. Here are just a few different ways that you can make a difference in the lives of people who truly need your help.

  1. Volunteer at a local hospital

There are a number of ways you can bring a smile to the face of people in the grips of illness. Think about what your special talents and what ways you’d like to serve. Perhaps you play a musical instrument, or you’re an expert crafter, or maybe you’d like to read to children – whatever way you choose – know that someone out there will appreciate your efforts more than you realize.

Also, remember that hospitals treat patients around the clock. You can plan around your busy work schedule and find a window of time to dedicate to helping others.

  1. Donate a toy to a child in need

Every child deserves to feel special, particularly on a big holiday like Christmas. Unfortunately, with expensive medical bills, many parents simply cannot afford to provide gifts for their little ones. Things like DVDs, stuffed animals, video games, or electronics all make great gifts. It may seem like a small gesture, but for a family in need, outside help lessens the financial responsibilities associated with gift giving.

  1. Give blood

Organizations like the American Red Cross look for blood donors year-round.  Every time an individual donates blood, they are literally saving lives. Nearly all people can comfortably spare some blood without any adverse side effects. Those who do experience temporary lightheadedness or dizziness.

Giving blood is particularly important if you a universal blood type. O blood types (positive and negative) are universal, meaning that can be transfused to any blood type.

  1. Donate supplies to our veterans

Give back to those who serve and sacrifice for our great nation. Organizations like the Disabled American Veterans (DAV) help soldiers get back on their feet after they return home from duty.

Two popular ways to help include: providing hospitals with assistance and finding meaningful ways to thank the vets for their services. Hospitals, nursery homes and clinics all rely upon volunteers to perform small, but important tasks. Appreciation for vets can come through assistance with housework, yard work, grocery shopping, or just being a friend and lending a sympathetic ear.

  1. Participate in a clinical trial

Many of today’s advances are direct results of clinical studies, and because of the diligent work of researchers, people have lived longer and healthier lives. These trials are the testing grounds for the future therapies available to the American public, and the medications that help improve drug management.

Clinical trials generate new scientific findings, leading to new innovations that can change the future of modern medicine. Additionally, improved medical care and treatment options for common diseases like diabetes, leukemia and lymphoma can truly impact millions of people.

If you are interested in participating in a clinical trial, please tell us a little more about yourself in the Contact section of the home page and we will respond to you to determine your eligibility for current and future studies.

A Look Back at Modern Medicine: How Did We Get Where We Are Today?

A Look Back at Modern Medicine: How Did We Get Where We Are Today?

Hundreds of years ago, herbs and plants were used as natural remedies for everything from headaches to mouthwash to poor digestion. Leaves, nuts and berries, known as botanicals, were all cultivated in an attempt to cure disease.

We’ve come a long way since those days. Today, routine immunizations are administered to toddlers, and as adults, we head to the doctor for annual check-ups as a preventative health measure. Modern doctors and researchers are committed to furthering medical developments and collectively improving our quality of life.

Here is a timeline highlighting some of the most significant modern medicine innovations:

Germs as a Cause of Disease

Chemist Louis Pasteur, known for pasteurization, was the first to make the connection between microorganisms and disease. Prior to his groundbreaking work, germs known as pathogens were not acknowledged as a cause of illness. His research laid the foundation for researchers for years to come.

Smallpox

Smallpox was a viral disease, with symptoms including rash, pustules and flu-like feelings. In the late 18th century, physician Edward Jenner experimented with exposing patients to the cowpox virus. Jenner’s was the very first vaccination developed to help prevent the spreading of a disease. Many consider him to be one of the most influential members of immunology.

Fleming’s Breakthrough Penicillin Discovery

In 1928, Scottish scientist Alexander Fleming discovered the first true antibiotic, capable of killing microorganisms, or pathogens. To this day, penicillin is still commonly used to cure bacterial infections like staph or strep throat. Fleming would later receive a Nobel prize for his scientific contributions.

The “Flu Shot”

The first influenza vaccination was developed in 1933, after researchers determined that the illness was caused by influenza virus types A and B. According to eMedicine Health, the vaccination was used to protect US troops in World War II. These vaccines “were not as purified as more modern vaccines, and the impurities in vaccines were thought to contribute to side effects such as fever, aches, and fatigue.” Today, similar symptoms may appear after a flu shot, but rest assured, the vaccination is designed to prevent the virus.

Polio Vaccination

Jonas Salk is credited with developing the vaccine for polio, which he announced to the general public on a radio show in 1953. Polio was a debilitating viral disease capable of immobilizing anyone afflicted. Wealthy and poverty-stricken children alike contracted polio; with famous Americans like Franklin D. Roosevelt suffering from the crippling disease. Fortunately, the polio vaccination has been widely used since 1961 and the disease itself has been virtually eliminated in the U.S.

The First Heart Transplant

In 1967, the first successful heart transplant was performed by Dr. Christiaan Barnard, lasting just over six hours. This time-consuming, invasive surgery, relies on the replacement of an unhealthy heart with a healthy heart from a donor. In addition to saving countless lives, Dr. Barnard’s surgical advances paved the way for future organ transplants.

Hepatitis A, B, and C

Hepatitis spreads through bodily fluid contact, like blood, saliva or semen. The disease causes inflammation of the liver and can lead to cirrhosis, liver failure, and liver cancer. Per Wikipedia,” The first Hepatitis B vaccine was approved in the US in 1981.” Additionally, “The first hepatitis A vaccine was approved in Europe in 1991 and the United States in 1995.” Hepatitis A and B are both routine immunizations for young children and have been since 1994. There is no vaccine available as of yet for Hepatitis C, but several vaccines are currently under development.[2]

Modern day Innovations

Today, stem cell research allows scientists to generate organs for qualifying patients. Livers and artificial kidneys are being developed by doctors to prevent patients from the long and stressful wait for healthy organs. According to Discover Magazine, “by making embryos, then removing stem cells from the embryo and cultivating them to grow into tissues that could cure diseases, replace organs and heal injuries.”

Learn more about modern medical innovations in our related blog, “The Latest Clinical Trial Innovations & Technologies.”