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.

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.

Clinical Trials: Then and Now

Mankind has historically had great interest in findings antidotes and cures. Centuries ago, our ancestors were exploring the effects of different diets and keeping a watchful eye on the effects of different plants. As a species, we want to protect our own, and clinical trials align perfectly with these age-old priorities.

Here is some of the earliest evidence of early experimentation with homeopathic treatments:

  • Using plants and citrus, biblical history shows clinical trials were conducted as early as 500 B.C.
  • In 1537, a Renaissance surgeon conducted an unintentional clinical trial while he was treating wounds and ran out of the standard treatment. He mixed together egg yolk, turpentine and oil of rose, and found that this treatment healed the wounds much more effectively than the original standard treatment.
  • In 1747, naval surgeon James Lind conducted the first controlled clinical trial in order to remedy a group of sailors suffering from scurvy. He put all of the sailors on the same diet, but gave one group additional items such as cider and vinegar and gave the other group lemon juice. The group who had the lemon juice recovered from scurvy in less than a week. Eventually, lemon juice became a necessary part of a sailor’s diet.

Introduction of Placebo and Blind Trials

The concept of a placebo first appeared in medical readings in the early 1800s, defined in the Hooper’s Medical Dictionary of 1811 as, “an epithet given to any medicine more to please than benefit the patient.” Placebos have since become a crucial part of many clinical trials, since they work psychologically more than physiologically; though not technically helpful, placebos are harmless.

“Blind trials” emerged in the 1900s, as another aspect of the placebo effect in which neither group being tested knows which treatment they are receiving, one being a placebo and one being the new drug.

Medical Mishap and the Federal Food, Drug and Cosmetics Act

In 1937, a treatment for strep throat, Elixir Sulfanilamide, was put on the market in liquid form after showing positive results in tablet form. This treatment method had not been tested on people or animals prior to becoming publicly available, and as a consequence, more than 100 people died. This led to the 1938 implementation of the Federal Food, Drug and Cosmetics Act which still acts as the basis for FDA regulation. 

FDA Regulations in Action

The FDA continues to enforce strict regulation when it comes to developing (and even testing) new medicines and treatments. In the 1960s, another public health tragedy was prevented as FDA medical officer Dr. Frances Kelsey worked to prevent the approval of thalidomide in the United States. Women around the world had been using it as a sleeping pill and to prevent morning sickness, but were reportedly giving birth to children with severe deformations and other birth defects—it was eventually discovered that this medication had never been tested on pregnant animals, much less people, thus reinforcing the importance of close drug regulations.

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 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 to Get Involved in Clinical Research

How to Get Involved in Clinical Research

Medical research leads to medical advancements, which helps to improve the health of millions of Americans. Conditions ranging from allergies to cancer to digestive health are all being studied thanks to the help of volunteers across the country. These volunteers range from children to adults of varying health conditions and diagnoses, and play an important role in answering vital questions in the medical research process:
Does the treatment in question work? If so, how effective is it? Is it better than current treatments?
Is the treatment in question safe? What are the side effects? Do the benefits outweigh the possible risks?
How is the treatment metabolized? Is a treatment absorbed or eliminated from the body differently in people with impaired liver or kidney function compared to people without impairment?

There are four phases of clinical trials whereby researchers attempt to answer these questions:
Phase One—treatment is tested for the first time in a small group (20-80 volunteers), in order to assess safety and side effects.
Phase Two—treatment is tested with a larger group (100-300 volunteers) to evaluate effectiveness and further assess safety.
Phase Three—treatment is tested with larger groups (1,000-3,000 volunteers) to confirm effectiveness, monitor side effects, compare with standard treatments and evaluate any additional information to ensure the treatment is used safely.
Phase Four—following FDA approval, researchers continue to monitor the safety, benefits and risks of the treatment with the help of long-term research volunteers.

According to the American Cancer Society, “it takes an average of about eight years from the time a cancer drug enters clinical trials until it’s approved.” One of the most significant barriers in creating new treatments is the amount of time it takes to conduct clinical research. This is largely due to the fact that many people are unaware that participating in a study is an option for them. Of those willing to participate, however, only certain people may be eligible to volunteer for a specific trial.

Volunteer Requirements

All clinical trials have specific participation requirements that can vary from study to study, called “inclusion criteria;” factors that disqualify a volunteer from participating are called “exclusion criteria.” This can include but is not limited to age, gender, location, diagnosis, medical history, etc. Inclusion and exclusion criteria ensure volunteer safety and increase the likelihood of obtaining necessary information.  The first step to participating in a clinical trial is confirming that all inclusion criteria is met.

Participation in a clinical trial is always voluntary, and volunteers maintain the right to leave a study at any time. Before making a choice to discontinue, however, it is important to talk to your doctor about how quitting a study may affect your health and/or future treatment options.

Prior to participating in medical research, be sure to do your own research—make every effort to make an informed decision about the necessary requirements, potential placebo usage, and any possible risks and/or benefits.

Volunteer Opportunities

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 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.

How Does Clinical Research Help Improve Disease Management?

How Does Clinical Research Help Improve Disease Management?

For individuals struggling with physical pain, discomfort and pain management are a regular part of daily life. Chronic illness prevents millions of Americans from living their lives the way to their fullest and participating in the activities that would otherwise offer fulfillment.

But, the good news is that scientific advancements can truly make a difference in people’s lives. The innovative world of medical devices and joint replacements have revolutionized the way that people get around and the quality of life they experience. Also, when you participate in a clinical study, your contribution may improve healthcare for future generations to come.

Clinical Research Helps Improve Disease Prognosis

With every new study, researchers are providing more comprehensive treatment options for individuals managing chronic conditions. Here are some specific illnesses that clinical researchers are working to treat:

With regard to Neuromuscular diseases, clinical trials play a key role in the discovery and development of new treatments for neuromuscular diseases, like Parkinson’s disease. The National Parkinson Foundation (NPF) has been participating in one of the largest observational studies ever. Regarding their research, they note: “discoveries made in the laboratory can help people with Parkinson’s today and in the future. NPF is at the forefront of Parkinson’s research, and clinical studies are central to our vision. Every year, insights from the Project help optimize Parkinson’s care, leading to better quality of life for people with Parkinson’s today and better health for people with Parkinson’s tomorrow.” 

Additionally, the Muscular Dystrophy Association (MDA) has stated: “we know how critically important clinical trials are to finding treatments and cures, which is why we’ve committed, by 2020, to doubling our research investment in clinical trials and drug development.”

Another group of people who are directly impacted are those with Mesothelioma. According to the Mesothelioma center, “Clinical trials provide patients with access to cutting-edge treatments that can make a difference in their life expectancy, and they also play an essential role in future advancements in the fight against asbestos cancer.”

According to the National Center for biotechnology Information, the discovery of Herceptin, a commonly-prescribed antibody for individuals with breast cancer, was based upon research gathered from “a cohort of more than 9,000 breast cancer patients whose tumor specimens were consecutively received at the University of San Antonio.” This targeted therapy has prevented the growth and spread of breast cancer cells in women across the country, and is also prescribed to disrupt certain types of stomach cancers.

Many other forms of cancers are being addressed by clinical researchers. For a complete list of clinical study options, visit clinicatrials.gov.

Consider Being a Part of a Clinical Trial

At OCRC, we offer a variety of clinical trials and research studies in which you can participate in our state-of-the-art clinical research facility. The Phase I-IV clinical trials that we specialize in range from a few days to a few months. All study volunteers receive all treatments and medical care related to the trial. Additionally, participants may be compensated for their time and travel. Health insurance is never a requirement for participation.

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.

Five Ways Clinical Research Helps Improve Medical Treatments

Five Ways Clinical Research Helps Improve Medical Treatments

The clinical research data gathered today will help pave the way for an improved understanding of disease and illness in the future. Both Researchers and manufacturers are continually making progress on new medications that will one day be prescribed to patients. Through scientific advances and trial and error, researchers are uncovering answers to complex health problems that millions of Americans face. Here are just a few ways that clinical research helps improve the latest medical treatments:

1. Generate scientific data

Researchers go to great lengths to understand how medications will impact segments of the greater population. Because no two people are alike – we all have unique DNA, environmental stresses and lifestyles – it is important that clinical trial data is representative and encompassing of all of these factors.

For instance, according to the National Institute of Health, women are more likely to struggle with depression, osteoarthritis and kidney disease. With these genetic predispositions in mind, the data researchers obtain about the effectiveness of associated treatments or therapies in women is particularly important.

2. Help researchers determine the effectiveness of current medical therapies and treatments

When testing a new medication or therapy, researchers look into the medication’s efficacy, potency, dosage, side effects and psychological impact on study volunteers. Healthy volunteers are imperative for researchers to fully understand the safety and effectiveness of new treatments that may one day potentially prevent, treat or cure diseases.

3. Contribute to scientific breakthroughs

Clinical trials are the testing grounds for future therapies and medications that will help improve the management of serious health conditions. The data gathered in clinical trials helps researchers better understand the effects of disease and illness on the body, and which medications offer the best treatment.

Many of today’s medical advances are the direct result of clinical trials. Researcher’s findings can help uncover cures for illnesses, enabling people to live longer and healthier lives.

4. Increase knowledge of disease progression

Many clinical studies address the ways illness progressively impacts the body. This information may help researchers identify superior intervention methods, which can contribute to an increased patient life expectancy and better quality of life.

Doctors also provide guidance and care, free-of-charge, and the patients provide doctors with important data. For individuals who meet the specific study criteria, this relationship can be particularly beneficial.

5. Help improve the lives of those with illness

Many clinical trial participants find it gratifying to help facilitate medical advancements that will improve lives, and possibly saves lives, down the road. According to National Institutes of Health (NIH), “Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.”

Life can be tough for individuals with chronic illnesses. The hope for a cure or a new therapy never fades and the more people who sign up for clinical trials, the better researcher’s odds are for finding new treatments.

Read more about cutting-edge medical innovations in our related blog, “The Latest Clinical Trial Innovations & Technologies.”

Who Funds Clinical Trials?

Who funds clinical trials?

Similar to board members overseeing top corporations, sponsors guide clinical trials toward successful outcomes. The best performing operations have committed leaders who keep the end goal in mind. Likewise, a sponsor’s oversight is critical to investigational drug development.

Sponsors play an important role in clinical trials

According to the Food and Drug Administration (FDA), clinical trial sponsors may be “an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.” It is important to note that a sponsor does not actually work directly with volunteers or conduct the medical research.

Sponsor’s key responsibilities include:

  1. Ensuring all Investigational New Drug (IND) regulatory documentation is submitted in a timely matter to the FDA;
  2. Assessing the viability of a clinical study plan;
  3. Designing every study to address key research questions related to the medical treatment or product;
  4. Developing beneficial procedures to help guide a study towards a successful outcome;
  5. Staffing the study with trial with the right doctor, or principal investigator;
  6. Working with investors to ensure a study has sufficient budget, from start to finish;
  7. Keeping the board apprised of the investigational drug’s approval status;
  8. And monitoring the continued progress of a clinical trial.

Individuals or organizations can sponsor clinical studies

According to the U.S. National Library of Medicine, clinical trial sponsors may be:

Additionally, physicians, professors, or researchers may also choose to sponsor a clinical study. These individuals are known as sponsor-investigators, as they personally conduct research and gather data.

Sponsors oversee specific study budgets and needs

Sponsors help secure the budget necessary for a clinical trial by facilitating grants and soliciting investor contributions. The costs associated with a given trial may range depending on the following variables:

  1. Number of participants
  2. Necessary staff size for study completion
  3. Pertinent research materials necessary
  4. Patient compensation,
  5. Duration of clinical study 

Learn more about clinical studies

At OCRC, we pride ourselves on the policies we put into place to keep everyone safe — both our staff and study volunteers. OCRC recognizes the importance of timely start-up and thorough documentation processing from initial contact through completion. Our streamlined and thorough planning, coordination and monitoring process ensures both efficiency and exacting quality.

We offer a variety of clinical trials and research studies in our state-of-the-art clinical research facility. All study volunteers receive all 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’re interested in signing up, 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.