Seven Ways to Keep Your Organs Healthy

Sun up to sun down, your body’s organs are working together to keep you healthy. Your liver breaks down harmful substances in your body, excreting that waste into your blood; your kidneys cleanse your blood of that waste, and your heart pumps the blood throughout the body.

This means that people with a liver, kidney or heart problem also have an increased risk of having problems with another organ—diabetes, high blood pressure, smoking or being overweight can all add to the risk.

On the other hand, this also means that by making efforts to improve the health of one organ, you are simultaneously improving your overall health. Here are seven ways to keep your organs healthy.

Stay hydrated

Water helps kidneys remove waste from blood, so it’s always a good idea to stay hydrated by drinking at least four to six glasses per day. If you become dehydrated, toxins can build up and affect your kidneys and your liver. While hydration keeps your blood vessels open to help blood travel freely, dehydration can make your blood thicker and more difficult for your organs to detoxify.

Eat a balanced diet

Natural sources of sugar such as fresh fruit are easier than refined sugars for your body to metabolize without overwhelming your organs. It also helps to eat a lot of fiber, such as fruits, vegetables and whole grains.

In addition to refined sugars, limiting high fructose corn syrup (soft drinks, baked goods, sweets) and foods with saturated fat and refined carbohydrates (white bread, white rice and pasta) will keep your body healthy and functioning properly. Additionally, too much salt can cause high blood pressure, which is a risk factor for heart and kidney problems.

Exercise consistently

Physical activity helps to decrease blood pressure and cholesterol levels, increase muscle strength, improve sleep, and control overall body weight. You don’t have to have an intense workout routine—just do something to get your heart rate up on a regular basis.

Be careful with supplements and over-the-counter medications

Mixing medications or taking more than the recommended amount can damage your liver, as it is where most drugs are broken down after being metabolized. Too much of certain vitamin supplements and even herbal remedies may be harmful to your kidneys, as they may build up and cause damage, or react poorly with prescribed medications.

If you’re unsure about which medicines may be more harmful than helpful, talk to your doctor.

Don’t smoke

Smoking causes hardening of the arteries, or even hardening of the kidneys, reducing blood flood in the kidneys and to the heart. It can also cause high blood pressure, which is a cause of both heart and kidney problems.

Additionally, limiting alcohol consumption can reduce damage to the liver.

Keep blood sugar controlled

High blood sugar can cause damage to heart, blood vessels and kidneys, among other essentials in the body. Monitor blood sugar levels frequently, and naturally lower them by following the steps listed above.

Get checked

If you have heart disease, get your kidneys checked; if you have kidney disease, get your heart checked—especially if you have diabetes or high blood pressure. Organs are precious – be sure to protect yours!

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 Do Data Privacy Laws Affect Clinical Trials?

Clinical research is a vital part of maintaining and improving the effectiveness of modern medicine. Many medical advancements are the direct result of diverse clinical study participants who all play an important role in new treatment developments. 

Clinical Study Data Privacy

As clinical research is collected, there are several benefits to sharing information among researchers. It is more economical, more efficient, and safer to recycle existing data than to conduct redundant clinical studies. However, with these benefits of sharing data comes the possibility of putting patient privacy at risk. 

Two ways that clinical data can be shared is through either an open-access or controlled-access model. Open-access can be the riskier option, as it means that the data is made publicly available and can be accessed by anyone without restrictions. In contrast, controlled access means that data is only released under certain conditions—for example, if the party requesting data can prove authenticity and genuine intent to research.

Understanding Volunteer Rights

Before deciding to take part in a clinical trial, potential volunteers should make sure that they fully understand their rights. Along with the right to leave a study at any time, clinical trial participants are entitled to informed consent through the Patient Bill of Rights.

Among one of these rights is the Health Insurance Portability and Accountability Act, or HIPAA. Essentially, the goal is to ensure that clinical study participants can be unidentifiable as individuals—in other words, anonymous. Data anonymization refers to the process of de-identifying those participants by removing “direct identifiers,” including:

  • Names and photographs
  • Geographic information smaller than a state (address, zip code, etc.)
  • Any date smaller than a year (birth date, admission date, etc.)
  • Contact information (telephone numbers, email addresses)
  • Social security numbers
  • Medical record, health plan numbers, account numbers
  • Vehicle/device identifiers
  • Websites and IP addresses

This listed information is referred to as Protected Health Information, or PHI. Once all of the PHI is removed from the data, it may be used without HIPAA restriction. 

Protecting Volunteer Privacy is a Top Priority

In certain studies, where exact numbers are necessary but may compromise a participant’s privacy, a random offset may be applied. For example, if the exact age of a participant is necessary, the birth date and date of record collecting would be calculated by adding exactly 91 days to each in order to generate a “dummy date.”

Information including place of treatment, sex, diagnosis, socioeconomic data, ethnicity, household and family composition is referred to as “indirect identifiers.” Indirect identifiers are much less likely than direct identifiers to pose a risk to a clinical study participant’s privacy.

The General Data Protection Regulation protects the health information of any individual, or “data subject” within the EU. The confines of the GDPR, which went into effect in May 2018, are much stricter than those of HIPAA, as they also protect data which researchers in the US may consider to be an “indirect identifier.”

Need More Info? 
Check out our Frequently Asked Questions. You can also contact us to inquire about current clinical trial volunteer opportunities, or check ClinicalTrials.gov and CenterWatch.com for current research volunteer opportunities.

Clinical Study Volunteer Protection: Understanding Your Rights

Medical research innovations and scientific breakthroughs are rooted in data that is predominantly obtained in clinical trials. These important studies provide improved treatment options and help medical professionals treat and prevent diseases and viruses. The outcomes of clinical trials have the potential to change millions of lives, but without the help of clinical study participants, clinical research would not exist as it does today.

How can I get involved?

There are several opportunities to get involved in clinical research as a volunteer:

ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants; your own doctor and/or community hospital may also be involved in clinical trials. Once you find a clinical trial that you are interested in volunteering for, check to see that you meet the inclusion criteria. “Inclusion criteria” refers to the factors that qualify participants for clinical trials, such as age, gender, diagnosis, medical history, etc. Factors that disqualify participants from clinical trials are called “exclusion criteria.”

Once you have decided to join a clinical trial, be sure that you know exactly what it entails.

What are my rights as a clinical study volunteer?

Regardless of what type of clinical trial you are joining, you are entitled to informed consent through the Patient Bill of Rights, including but not limited to:

  • The right to safe, considerate and respectful care
  • Volunteer confidentiality
  • Complete information (such as protocols, risks and benefits), explained in a way that is understood by all volunteers
  • Appropriate assessment and treatment of pain and discomfort
  • A medical summary sent to your physician once the trial has concluded

As a clinical study participant, you also maintain the right to withdraw from a trial at any point. However, you will want to check with your doctor about any negative side effects that may occur if you are not present for the full duration of the trial.

In addition to the Patient Bill of Rights and informed consent procedures, there are other safeguards which protect the rights and safety of any clinical study participants. The Protocol Review Process ensures that all protocols must be reviewed and approved by an institutional review board before a trial can begin. There is also a Patient Representative, who assists in communication between the patient and hospital and is readily available to discuss any issues with the volunteer.

Be sure to do your research before joining a clinical trial in order to ensure that you are making an informed decision. As a participant, you will always have the right to know the answers to important questions—you have the right to ask clinical study staff any questions you have at any pointin the process.

What questions should I ask?

The information that you will need about a clinical trial ranges depending on the type of study. Of course, you will want to know the following:

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

If you would like to know more about participating in clinical research, you can always contact us to inquire about current research volunteer opportunities.

How Does Randomization Affect Clinical Trials?

Scientific validity is a top priorty in clinical trials and thus, methodologies and processes are essential to the overall success of the study. Clinical trials are typically conducted by comparing two medical treatments—with at least one factor being manipulated—in order to test the effectiveness of new and existing treatments.

Often, the test is done to address one of the following:

Superiority: is one treatment better than the other?

Non-inferiority: is one treatment no worse than an already existing one?

Equivalence: are the two treatments in question essentially the same?

Of course, volunteers are crucial to these clinical trials. Effectiveness of experimental treatments can only be accurately analyzed through the use of human volunteers, who get to play an active role in the development and improvement of treatments.

When assigning either medications or placebos to volunteer groups, there is—ironically enough—a strategy to making sure that the groups are, in fact, completely random.

So, what is randomization?

Participants in each volunteer group should be systematically different in terms of age, sex, diagnoses, or any other factors that may be influential in the clinical trial. This is done in order to ensure scientific validity and minimize any potential bias. For example, without randomization, a researcher may subconsciously decide to offer the new treatment to the group that is more likely to respond well.

How do researchers randomize their clinical trials?

While there are some less popular methods of random sampling, the most common randomization methods include simple randomization, block randomization, and stratified random sampling.

Simple Randomization

When you want to choose a card from a deck, or a number from a hat, how do you make sure it’s random? Most likely, you simply make a choice at random… or use a random number generator. Simple randomization is just that: simple. Each individual or group has an equal chance at being selected to either try the new treatment or the placebo, with no preconceived ideas about how they will respond.

Block Randomization

Block randomization takes it a step further from simple randomization. Volunteers are randomly separated into groups, or “blocks,” of equal size. Within each of those groups, the treatment is assigned at random to an equal number of people. With this method, there are more opportunities to compare and contrast the placebo-assigned and treatment-assigned participants with several smaller sample sizes instead of one large sample size.

Stratification Randomization
With this method, volunteers are strategically categorized into groups based on certain criteria, such as age, sex, or diagnosis. Once they are split into those groups, simple randomization is used to select an even number of participants from each group. This is often used to ensure that sample groups do not overlap, and to make sure that the results are as close as possible to being truly representative of the sample population.

How Can I Participate in Clinical Trials?
ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants. Your own doctor and/or community hospital may also be involved in clinical studies and trials. Additionally, you can always contact us to inquire about current research volunteer opportunities.

 

Clinical Trials 101: A guide to Understanding Clinical Research Language

Clinical research relies upon an ongoing process that evolves as new data becomes available. Any and all medical treatments that are used now first underwent multiple phases of clinical studies in order to become FDA-approved.

There is always a diverse variety of new information being discovered, which can be fascinating to keep up with. However, you shouldn’t have to conduct your own research just to figure out what it all means. We’ve compiled our own glossary of clinical research terminology, so you don’t need to have a career in clinical research in order to understand the basics. 

Clinical Research vs. Clinical Trials

Clinical research is a type of medical research which uses human volunteers to develop and improve medical treatments. While clinical researchers will continue to evaluate the data post-study, clinical trials are simply the individual studies in which data is collected.

Inclusion & Exclusion Criteria

Inclusion and exclusion criteria refers to the volunteer requirements for participating in a clinical trial. These factors can include age, gender, medical history, etc., and vary according to each clinical trial. Inclusion criteria are the factors which allow someone to participate as a volunteer, while exclusion criteria disqualify participation.

Healthy volunteer vs. Patient Volunteer

A healthy volunteer is someone with no significant health problems related to the study, while a patient volunteer is someone with a diagnosis or health problem related to the clinical trial in question. Both types of volunteers are important for testing and helping to better understand treatments.

Informed Consent

Informed consent is an agreement (in writing) which includes a summary of the clinical trial, treatment procedures and schedules, and risks and benefits. It also lays out all of one’s rights as a volunteer, including the right to leave the trial at any time.

Phases of Clinical Trials

There are four phases of clinical trials: the first phase being a test in a small group of 20-80 volunteers, the second with 100-300 volunteers, and the third with 1,000-3,000 volunteers. The fourth phase is continued research following the FDA approval. OCRC specializes more in Phase 1 clinical trials.

Placebo
A placebo is a part of a treatment which visually appears as the new treatment being investigated, but does not have any active ingredients. Volunteers generally do not know whether they are being given a placebo or active treatment; therefore the effects can compared side-by-side. 

Principal Investigator
A Principal Investigator is the person in charge of overseeing a clinical trial. In addition to PIs, there are also several other paths that can be taken within the clinical research career.

Randomization

Randomization is when two or more treatments are assigned to volunteers by chance rather than choice, comparing new treatments and standard therapy. This is done in order to prevent bias, such as when doctors assign volunteers to trial groups based upon their medical history or diagnosis.

Single-Blind vs. Double-Blind

A single-blind study means that the participants in a clinical trial do not know whether they are receiving a placebo or the active treatment; a double-blind study means that both the participants and the researchers do not know whether the treatment is the placebo or not. This is done to reduce the risks of bias or a placebo effect, which can produce superficial results.

Need More Info?
Check out our Frequently Asked Questions. You can also contact us to inquire about current clinical trial volunteer opportunities.

Is a Career in Clinical Research Right for Me?

Clinical research has led to the development of countless scientific breakthroughs—in fact, before any drug or treatment can become FDA-approved and publicly available, it must first go through four trial phases with the help of clinical trial volunteers and closely monitored evaluation and analysis.   

There are several ways to get involved with clinical trials by volunteering—ClinicalTrials.gov and CenterWatch.com provide listings for clinical trials which are recruiting participants; you can also contact us to inquire about current research volunteer opportunities.

But what about being on the other end of things? Have you ever wondered how to become a clinical researcher, or if a career in clinical research could be right for you? If you want to put your science degree to use, make a difference in people’s lives, and further the development of both your career and the medical world, there’s a good chance that this could be the career for you.

What types of work can a clinical researcher do?

With the variety of diseases, treatments and ongoing studies that exist, there is also a variety of people working together—this, of course, also means a variety of work environments, including (but not limited to):

  • Clinical Research Scientist
  • Data Manager
  • Quality Assurance Auditor
  • Medical Writer
  • Biostatistician
  • Clinical Safety Analyst

What qualifications are needed in order to be a clinical researcher?

If you have obtained or are pursuing an undergraduate degree in a field relating to biology, physics or mathematics, you have already taken the first step toward a career in clinical research. Depending on which area of clinical research you want to specialize in, you may then go on to pursue a master’s degree, and an M.D. or Ph.D. Keep in mind that it is important to have a strong academic record throughout your studies, as many programs are quite competitive.

Licensure may be required depending on your specialization. If performing medical procedures on human volunteers, a medical license is required.

Where do clinical researchers work?

“There are a number of things that appealed to me as a CRA (Clinical Research Associate),” writes a DOCS member with said job title. “I liked the flexibility—you can work from a number of different locations… I enjoy working from home when I can.” Clinical researchers may also work in hospitals and medical labs; they may also travel frequently for their work.

What is a typical career path for a clinical researcher?

There is no “one size fits all” formula for becoming a clinical research—as mentioned earlier, this career field is full of variety. New or inexperienced employees often start in administrative or assistive roles before moving on toward setting up trials and collecting data, and then toward project management and design.

If you are science-minded, detail-oriented, and have good communication skills, there are several options out there for you within the field of clinical research. Consider connecting with others within an area of the field that you are interested in to learn more about the specifics of day-to-day life as a clinical researcher.

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.

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.