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.

How to Get Involved in Clinical Research

How to Get Involved in Clinical Research

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

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

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

Volunteer Requirements

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

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

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

Volunteer Opportunities

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

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.

Understanding the outlook for post-menopausal women

While menopause is a ubiquitous experience for women the world-over, the duration and intensity of the experience are as unique as the females themselves. When hormone fluctuations, night sweats, and insomnia subside and post-menopause sets in, new risks evolve for serious health concerns that all women should be aware of.

What is menopause?

At the onset of menopause, a woman’s estrogen levels will decrease, causing her menstrual cycle to change, and eventually conclude. Unless a woman had her ovaries removed at a young age, she will undoubtedly experience the symptoms of menopause.

Menopause happens in phases, typically beginning in a woman’s late 30s of early 40s. It frequently lasts around four years but can be longer or shorter depending on the individual. Additionally, once menopause occurs, pregnancy is no longer a viable option.

What are the signs of post-menopause?

Post-menopause usually occurs in a woman’s late 40s or early 50s. Women who have not had their period in over a year are considered postmenopausal.

While menopause only lasts a few years, post-menopause may actually stretch on for up to 10 years. During this time, the best way for women to combat their decreasing estrogen levels is to prioritize their health, diet and sleep habits.

What are the most common post-menopausal concerns?

Once the symptoms associated with menopause cease, it is important for women to monitor certain health concerns. According to the Cleveland Clinic, “as a result of a lower level of estrogen, postmenopausal women are at increased risk for a number of health conditions, such as osteoporosis and heart disease.”

Key concerns include:

  1. Risk for cardiovascular disease
  2. Bone density decline and/or osteoporosis
  3. Narrowing or hardening of the arteries
  4. Heart attack or stroke
  5. Unregulated salt intake, blood pressure or cholesterol

Women have unique health concerns as they age, and the same can be said of men. While men commonly struggle with prostate concerns or cancers, women need to keep an eye on bone density and breast tissue changes.

Take control of post-menopausal symptoms and experience

Here are a few tips to help you manage this temporary condition:

  1. Daily vitamins: Amazon offers a variety of different supplements specially designed for a woman’s changing needs.
  2. Education: Barnes & Noble offers many different books about menopause, authored by both doctors and every day women with helpful stories and tips.
  3. Stay active: Addressing cardiovascular health can dramatically improve energy levels, weight management, and life expectancy. There are a number of exercise routines and gyms to choose from, and there is a program suited to every woman’s unique needs.

It’s not all bad news…

The good news for all women is that there are extensive resources about this topic. Yes, there are additional concerns associated with menopause and post-menopausal health, but there are also a lot of positives, too. The days filled with cramps, acne breakouts, and unusual food cravings will be gone, along with concerns surrounding unplanned pregnancies. Changes associated with the aging process are inevitable, but a good attitude is the key to enjoying life to its fullest.

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.

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

How do researchers know if a clinical study is a success?

Clinical trials help researchers compare and contrast medications, which leads to better outcomes for patients across the country. The main objective of a researcher is to collect data to establish the effects of an investigational drug, but his or her specific goals may differ depending on the study.

Declaring a clinical trial a success means that the researchers have successfully met their objective. The following list details fundamental attributes of a successful clinical trial:

  1. A sufficient number of participants to generate accurate data.

Researchers must first meet the specific threshold for study participants before they can investigate a drug’s safety and efficacy. The volume of participants, based on study protocol and the Food and Drug Administration (FDA) requirements, must be sizeable enough to clearly demonstrate the validity of their findings.

  1. A clear difference in the data from the experimental drug and the placebo.

During a clinical trial, a “control” group receives a placebo drug, enabling researchers to avoid unintentional biases, and identify the statistically proven benefits or potential health concerns associated with an experimental drug.

Clinical researchers closely monitor participants for changes and meticulously document findings during the study. The more noteworthy the difference between these two groups, the more they can attribute to the drug’s effect.

  1. A demonstration of how the medication is metabolized in a certain segment of the population.

Researchers need to understand exactly how the medication is tolerated within unique segments of the population in order to complete the Investigational New Drug Application (IND). They also research which segments of the population experience the highest success rate with the investigational drug.

Both the FDA approval and the pharmaceutical manufacturer’s vested interest hinge on the results of the clinical study. If the drug does not perform well in clinical trials, it likely be reformulated or abandoned altogether.

Learn more about clinical research

ClinicalTrials.gov, the FDA website and our blog catalog are all great sources for 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 Orlando Clinical Research Center, study participants receive complimentary 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 for 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.