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.

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.

A Deeper Look at The Drug Development Process

The United States is a global leader within the pharmaceutical industry and one of the largest markets in the world. With the help of clinical researchers and the U.S. Food and Drug Administration (FDA), medications are tested, manufactured, and disseminated to pharmacies across the country.

The primary objective of the pharmaceutical industry is to manufacture medications and devices that help prevent infections, maintain health, and treat diseases. Read on to learn more about the unique role clinical trials play in the drug development process.

Understanding Clinical Study Approval Phases and Processes

The clinical research process for all new medications is comprehensive, rigorous, and extends through multiple stages. At any given time, thousands of clinical trials are in-progress, yet “only one in every 5,000 compounds that makes it through lead development to the stage of pre-clinical development becomes an approved drug.”

The following FDA infographic summarizes the process that an investigational drug undergoes:

clinical trial process
The initial process begins with researchers isolating compounds in the lab. Then, “using the in vitro laboratory, 5,000-10,000 new and previously developed compounds are tested for biological activity,” per the FDA.

Next, Investigational New Drug Application paperwork must be filed and eventually reviewed by the FDA. Once the researcher receives an initial approval, lead compounds are tested on animals. Animal testing typically begins with fish, mice, or rabbits to determine if the medication is safe enough to be tested in humans. Certain animals, like mice, are similar enough to humans on a molecular level, for scientists to gather plausible causation.

The FDA reviews all animal testing findings and results before making their final decision. Provided the medication passes this step, FDA-monitored human trials begin to assess whether the drug is effective and safe for humans.

Phase 1: A small group (20-80) of healthy individuals or individuals with special conditions participate in this phase. Safety is a top priority for researchers overseeing this phase, which focuses on small groups of special patient populations, such as those with kidney disease, liver disease, and diabetes for example.

Phase 2: A slightly larger group participates in Phase 2, which addresses the investigational device or medication’s effectiveness. Safety is continuously evaluated and side effects are also carefully monitored.

Phase 3: A large group (up to 1,000+) participates in this phase, which allows researchers to develop a further understanding of dosing and side effects of the medication when combined with other drugs.

Once trials are completed, the FDA reviews the application and determines a final ruling at a review meeting. If the drug receives the final approval, it is released to the general public. 

Learn More About Clinical Trials

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

At OCRC, we explain our methodology to every participant and we pride ourselves on the policies we put into place to keep everyone safe — both our staff, and study volunteers. The Phase I-IV clinical trials that we specialize in test investigational medications being developed by pharmaceutical and biotech companies. All participants receive treatments and medical care related to the trial at no cost. Additionally, participants may be compensated for time and travel. Health insurance is never a requirement.

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

What is the Drug Development Process?

What is the Drug Development Process?

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

Initial Development and Discovery

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

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

Preclinical Research

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

Clinical Research

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

The key objectives are to:

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

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

FDA Review

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

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

Postmarket Studies

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

Learn More About Clinical Trials

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

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

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

5 Ways to Give Back to Your Community this Holiday Season

5 Ways to Give Back to Your Community this Holiday Season

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

  1. Volunteer at a local hospital

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

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

  1. Donate a toy to a child in need

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

  1. Give blood

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

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

  1. Donate supplies to our veterans

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

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

  1. Participate in a clinical trial

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

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

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

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

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

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

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

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

Germs as a Cause of Disease

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

Smallpox

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

Fleming’s Breakthrough Penicillin Discovery

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

The “Flu Shot”

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

Polio Vaccination

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

The First Heart Transplant

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

Hepatitis A, B, and C

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

Modern day Innovations

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

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

What is kidney dialysis?

What is kidney dialysis?

Kidneys are small fist-sized organs on either side of the abdomen that purify blood and help rid the body of waste. You might not be fully aware of the importance of your kidneys, but they play an important role in your body. From regulating blood pressure and mineral balances to regulating fluids, to creating red blood cells; if your kidneys are impaired, your health and wellbeing will eventually be compromised.

What is dialysis?

Kidney dialysis is a common procedure designed to mimic the functionality of the kidneys. This life-saving treatment helps restore salts, removes waste and fluids in the blood, stabilizes blood pressure and helps the body reach a healthy balance.

What are the different types of kidney dialysis?

Hemodialysis patients typically visit a treatment center three times per week and stay between 2-4 hours. According to The National Kidney Foundation, patients visit “a special building that is equipped with machines that perform the dialysis treatment. Additionally, the hemodialysis machine “adds the proper materials to purified water for the dialysis machines.”

Peritoneal Dialysis, inversely, relies on a catheter or a tube to clean the blood internally. Blood remains within arteries and veins while it is filtered and the impurities exit the body via the catheter.

What are the symptoms of kidney damage?

Kidney damage signs include fatigue, frequent urination, itchy skin, tissue inflammation, excessive water retention, high blood potassium, shortness of breath, loss of appetite and anemia. Not all of these symptoms are present in all patients, and it is important not to assume that just because one or more of these symptoms are present that an individual needs kidney dialysis.

What is the purpose of kidney dialysis?

Proper kidney functionality is imperative to good health, mobility and longevity. When the kidneys are compromised, an individual’s waste will quickly build up within the bloodstream. Eventually, enough waste in the blood may lead to a coma or death.

Kidney dialysis helps treat:

  • Acute Kidney Injury: This condition may result from a sudden drop of blood flow, certain infections, serious urinary blockages or ingesting poison. Dialysis may only be temporary in this case, requiring just a few sessions.
  • Diabetic Kidney Disease: Patients with Diabetic Kidney Disease experience a “leak in abnormal amounts of protein from the blood into the urine,” according to patient.info. Healthy kidneys pass trace amounts of albumin to the urine stream. Additionally, “a raised level of albumin in the urine is the typical first sign that the kidneys have become damaged by diabetes.”
  • End-Stage Renal Disease: As the kidneys increasingly work to keep up with the needs of the body, Chronic Kidney Disease may develop. Diabetes and high blood pressure are often to blame for this serious health problem, which typically evolves over years. This condition may often precede a kidney transplant for patients who are blessed with a blood-type-matched donor.

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 Aranesp® for low blood count, 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.

Clinical Research Toolbox

While Americans face unique health risks, thanks to modern clinical research and medical advancements, our overall life expectancy has increased in the past 100 years. Clinical trial participants provide researchers with invaluable data, but with so many different study options, it can be overwhelming to find the right study, with applicable requirements, in a convenient location. Here are a few different resources that prospective volunteers should bookmark to simplify the process of finding and signing up for a clinical study.

Clinicaltrials.gov

As a service of the U.S. National Institutes of Health, clinicaltrials.gov provides a full database of:

  • Currently-enrolling clinical trial studies;
  • Clinical study requirements;
  • Study glossaries and FAQs; and
  • Data and resources about clinical studies.

The website was established due to the Food and Drug Administration Modernization Act of 1997 (FDAMA). “FDAMA required the U.S. Department of Health and Human Services (HHS), through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions.”

 

Stay informed with the clinicaltrials.gov full list of open clinical studies

This website aggregates all of the different clinical trials across the country. Currently, 229,011 studies are in progress across all 50 States and in 193 countries. Clinical researchers are looking for diverse participants – with study topics ranging from mental health to HIV/AIDS, to cancer to alcoholism. Anyone who is interested in clinical trials can sort the studies by topic, location, enrollment status or required pre-existing conditions.

 

The National Institutes of Health

The National Institutes of Health (NIH), “serves as the nation’s medical research agency — making important discoveries that improve health and save lives.” With a goal of promoting the health and wellbeing of Americans, the organization is made up of 27 different components, each which focus on a different part of the body or illness, with respective budgets, staff, and facilities. “Some research is performed on campus in state-of-the-art laboratory facilities, although more than 80% of research activities are conducted by scientists working in every state and around the world.”

Under the U.S. Department of Health and Human Services, the goal of NIH is to foster creative discoveries and innovative research to improve Americans’ health; develop, maintain and expand new scientific knowledge to help prevent disease; to hold researchers to the highest level of accountability; and to ensure the public’s return on investment with regard to research.

 

The U.S. Food & Drug Administration

The U.S. Food & Drug Administration, or the FDA, protects consumers health and wellbeing by regulating medications and medical devices, intended for consumption by the general public. The FDA is also “responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”

Additionally, the Center for Drug Evaluation and Research, under FDA authority, monitors all products consumers interact with – from whitening toothpaste to homeopathic lotions to back pain relief – medications across the board are reviewed by this important government agency. Visit their website to learn more about the latest drug technologies and approvals.

 

Learn more about the clinical study process

If you are interested in learning more about clinical trials, our staff at OCRC is happy to offer tours at our state-of-the-art clinic to volunteers who meet study criteria. Visitors receive a firsthand experience in our clean and stress-free space located in sunny Orlando, FL. Additionally, if any prospective clinical trial volunteers have questions or are seeking trials for a particular condition, we are available to help them find a location that may be recruiting, even if we do not have any related open studies.

Five Things You Didn’t Know About Clinical Trials

Every year, researchers work with thousands of volunteers to collect new data about medications; and shortly thereafter, new treatments enter the marketplace in part, due to the impactful findings collected. Clinical studies are essential to the current U.S. drug-approval process, to establishing medication efficacy and safety, and to the future of medical innovation.

Here are a few interesting facts about clinical studies that you might not already know:

  1. Sponsors enlist the help of medical researchers to facilitate clinical studies

Sponsors manage and monitor clinical studies to ensure continual progress. Either an individual or an organization may sponsor a clinical trial, but this role is always critical to the study’s outcome.

Additionally, sponsors are in charge of:

  • Selecting and hiring a principal investigator entrusted to oversee the study;
  • Keeping the FDA apprised of study findings; and
  • Ensuring budget adherence and upholding investor relations.
  1. An Institutional Review Board (IRB) determines the viability and soundness of all newly-proposed studies.

An IRB determines which studies are approved for the respective clinical study phases, and also ensures the well-being of all participants throughout the clinical trial process. These researchers, doctors and members of the medical community defend the ethical rights of all study volunteers.

With volunteer safety and welfare being a top priority for Institutional Review Boards, trial protocols and research methods are closely examined to prevent any unnecessary risks or dangers.

  1. Medications are still monitored well after entering the market place.

Post-market surveillance examines the long-term safety and effectiveness of new medications and seeks to expose any previously unidentified side-effects. The Federal Drug Administration (FDA) explains, “These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance and clinical outcomes, and facilitate the development of new devices, or new uses for existing devices.”

With regard to medical devices, the FDA also keeps a watchful eye on tracking, device malfunctions, injuries or deaths and product registrations.

  1. Many organizations reimburse participants for travel and time.

In addition to certain private organizations, the federal government provides clinical trial funding. Clinical research facilities have differing policies, and it is important to carefully review volunteer compensation and reimbursement policies prior to enrolling and participating in a clinical study.

At OCRC, all study participants receive study treatments and medical care related to the trial. Additionally, participants may be compensated for time and travel. Health insurance is never a requirement.

  1. Today, there are more than 226,579 clinical studies underway.

Clinical researchers work in many different locations, across all 50 states, to advance medical knowledge and to improve the health and wellbeing of the general population. Clinical studies are performed at hospitals, medical clinics and at cancer centers. This is often the case because of the innovative therapies available at cancer centers.

Researchers are currently looking for volunteers with diverse backgrounds, ages, ethnicities and health conditions to enroll in current clinical studies. Learn more at clinicaltrials.gov.

How Does The Body Metabolize Medication?

When medications make their way through the human body, they encounter different organs before finally being released in the bloodstream. While the process may sound straightforward, different drugs dissolve at different rates, different formulas, and dosages breakdown differently – and, everybody’s body metabolizes medication uniquely. These are just a few of the many complexities behind the nature of drug absorption and metabolism.

How does medication enter the bloodstream?

The vast majority of medications are taken orally and are broken down within the gastrointestinal tract. Once the medication arrives, it is broken down by stomach acids before it passes through the liver and then enters the bloodstream. Certain medications may stay in the bloodstream longer – it all depends on the dosage and drug family consumed. 

What factors influence medication absorption?

There are several factors at play when determining the overall time required for medication to fully digest. The following factors all impact an individual’s sensitivity to and absorption of medication:

  • Age
  • Weight
  • Gender
  • Time of day taken
  • Level of physical activity
  • Level of stress
  • Content of stomach and PH level
  • Presence of other medications

Gastric acids may prevent or slow the breakdown of certain medications. Additionally, when a medication is metabolized in the liver, its potency will decrease along with its effectiveness before the therapeutic reaches the bloodstream.

According to Merck, in order “to be absorbed, a drug given orally must survive encounters with low pH and numerous GI secretions, including potentially degrading enzymes.” This research exemplifies the reasoning behind doctor’s common orders to take a medication with a full stomach. There is science behind the reason why it’s advisable to follow his or her orders.

How long does it take for the body to absorb medication?

The method of drug consumption affects the rate at which the medicine travels throughout the bloodstream. The solubility of the medication also affects how long it will take for the medication to dissolve. In general, it typically takes approximately 30 minutes for most medications to dissolve.

When a medication is coated in a special coating – which may help protect the drug from stomach acids – often times it may take longer for the therapeutic to reach the bloodstream. For example, an aspirin may dissolve in a matter of minutes, while gel caps may take much longer, due to their gel coating. These pills may also be easier to swallow, so it is important to weigh the pros and cons of different medications.

How is medication administered?

  • A tablet, capsule or syrup taken orally
  • Tablets or pills dissolved sub-lingual
  • Medication Inhaled or droplets administered to eyes, ears, nose or throat
  • Injection via IV or intravenously in a vein
  • Rectal administration
  • As a patch or gel applied to the skin
  • Controlled-release

Certain medication forms are associated with more potent medications. For example, intravenous medications may be more potent than capsule. A sublingual tablet typically moves more quickly through the circulatory system, and is thus rapidly metabolized. The same is true of rectal medications, where a significant number of blood vessels are present.

How do clinical trials help improve the future of medicine?

Clinical trials are an integral and essential part of the drug development process. Each and every week, researchers across the country work closely with study participants to understand the effects of newly-developed medications. Once this information is gathered and documented, researchers are able to evaluate the overall effectiveness of the new medication or treatment. The data that is produced in the successful studies eventually yields medications that are sold to the public. In short, these trials are the testing grounds for the future therapies available to the American public, and the medications that help improve drug management.

Here are a few ways that clinical trials are shaping the future of modern medicine:

Clinical Trials Increase Knowledge Surrounding Disease Progression

Clinical research requires sophisticated and comprehensive testing in collaboration with communities that are affected by a given disease or illness. With this data, researchers are better able to treat or cure disease and illness.

According to National Institutes of Health (NIH), “Only through clinical research can we gain insights and answers about the safety and effectiveness of drugs and therapies. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those diagnosed with an illness, in clinical research.” Without clinical research, many of these scientific advances simply would not exist.

New Technologies May Lead to New Medicinal Alternatives

Clinical trials may help researchers identify superior intervention methods, which can contribute to an increased patient life expectancy. The technologies that researchers test may offer doctors a better understanding or method of measuring a patient’s wellbeing.  Unique alternatives can be developed for different ages, genders, ethnicities, genetic profiles, chronic or acute conditions, and for different co-occurring diseases.

A Quintiles article on this topic states, “Through the expedition of data sharing, improving clinicaltrials.gov, and creating linkages between Electronic Health Records (EHR) and clinical research databases, we can facilitate more rapid and accurate identification of patient recruits, which is one of the most time-consuming and high-risk steps in the trial.”

Researchers Explore Ways to Measure or Improve the General Population’s Overall Quality of Health

By increasing the volume of knowledge surrounding how medication improves human health, researchers can help improve patient’s disease management and quality of life. According to Joan Chambers, Chief Operating Officer, CenterWatch, “Clinical trials help educate researchers and physicians on the types of treatments that work or do not work in people as well as providing different medical options for patients to consider.”

Consider Enrolling in 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, and test investigational medications being developed by pharmaceutical and biotech companies. All participants 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 are interested in participating, please tell us a little more about yourself in the Current studies section of the home page and we will respond to you to determine your eligibility for current and future studies. Your contribution may improve healthcare for future generations.

What is Liver Disease?

The liver is the largest internal organ and the largest gland within the human body. It is approximately the size of a football and serves as important metabolic functions. The liver produces proteins that are necessary for coagulation and blood clotting. The liver also converts nutrients or fats into substances the body can utilize, and breaks down toxic substances into matter that the body can efficiently release.

Liver disease includes anything that damages or negatively impacts liver cells. Liver damage can range from minor to severe. Here are a few commonly occurring types of liver disease: 

Alcoholic Hepatitis

According to liverfoundation.org, “Alcoholic hepatitis is characterized by fat deposition in liver cells, inflammation and mild scarring of the liver. Symptoms may include loss of appetite, nausea, vomiting, abdominal pain, fever and jaundice.” Fortunately, this condition can be reversed with the right lifestyle changes, including abstinence from alcohol.

Hepatitis A, B or C

Hepatitis is a disease involving inflammation of the liver. While there are five different types of Hepatitis, they all cause liver disease. Chronic hepatitis may lead to damage to the liver or Cirrhosis.

According to the World Health Organization (WHO), “The condition can be self-limiting or can progress to fibrosis (scarring), cirrhosis or liver cancer. In particular, types B and C lead to chronic disease in hundreds of millions of people and, together, are the most common cause of liver cirrhosis and cancer.” Thankfully, today we have a vaccine available for hepatitis A and B and new treatments available to successfully treat hepatitis C.

Cirrhosis

Cirrhosis is often times asymptomatic until it has progressed to a more sever level. According to WebMD, “Cirrhosis is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue, eventually preventing the liver from functioning properly. The scar tissue blocks the flow of blood through the liver and slows the processing of nutrients, hormones, drugs, and naturally produced toxins. It also slows the production of proteins and other substances made by the liver.”

Hemochromatosis

Hemochromatosis is a disease where too much iron builds up inside the body. This inherited disorder affects predominantly Caucasians. According to the National Institute of Diabetes and Digestive and Kidney Diseases some of the side effects of Hemochromatosis include: joint pain, fatigue, unexplained weight loss, abnormal bronze or gray skin color and abdominal pain.

Nonalcoholic Fatty Liver Disease

The cause of nonalcoholic fatty liver disease (sometimes referred to as NASH) is unknown, but doctors know it is often caused by obesity, high cholesterol, type 2 diabetes or certain medications. It affects people who do not drink or drink very little. When caught early, people who experience this disease may partially or fully recover.

Learn more about liver disease from your doctor

If you are experiencing liver disease symptoms, talk to your doctor about liver disease. You may also consult with the doctor at OCRC if you meet our liver study criteria. If you’re interested in signing up for a clinical trial, please tell us a little bit more about yourself in the Contact section of our home page and we will respond to you to determine your eligibility.

What Are Exclusionary and Inclusionary Clinical Trial Criteria?

Inclusionary and exclusionary criteria are specific limitations that clinical researchers place on a recruited study population. Researchers may screen and select specific participants in order to isolate variables that pertain to the experimental medication’s safety, effectiveness, dosing recommendations, or side effects.

What is the difference between inclusionary and exclusionary criteria?

Inclusionary or exclusionary factors include age, gender, weight, ethnicity and medical history. These variables are closely connected to a specific medication’s effectiveness and metabolic breakdown in the body; consequentially, it is important for researchers to control these variables for the benefit of the study.

According to the National Institutes of Health, “Inclusion and exclusion criteria are not used to reject people personally; rather, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information they need.”

Why do these criteria exist?

Excluding or including a specific variable can have a dramatic impact on the volunteer population, and thus the scientific validity of the researcher’s findings. Selecting the right group of participants enables researchers to generate more accurate data.

For instance, if a researcher excludes young men from a study about a medication’s effectiveness, additional research will be required before a manufacturer can move forward with mass distribution.

Clinical trial requirements and criteria

Pre-existing conditions and requirements vary depending on a researcher’s study protocol. Currently at OCRC, our studies have slightly different criteria.

Our Low Testosterone study requires that participants:

  • Are between 18-75 years old
  • Have low testosterone (we can do the test if levels are unknown)
  • Have no history of prostate or breast cancer

Our Kidney disease study participant qualifications are:

  • Age range between 18-80
  • Presently have kidney impairment or disease
  • Currently seeing a nephrologist and taking medicine such as: Procrit® or Aranesp® for low blood count, or PhosLo® or Renagel® for high blood phosphorus

Our Liver Studies participants should:

  • Be between 18-75 years old
  • Have liver impairment or disease
  • Study volunteers are more likely to qualify if presently taking medicines such as spironolactone, lasix®, lactulose, aldactone®, or Rifaximin
  • Individuals with abdomen fluid (called ascites) or cirrhosis are also welcome