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 Causes Low Testosterone Levels?

What Causes Low Testosterone Levels?

One in every six American men experiences low testosterone levels. The condition is so common that Low-T (as it’s abbreviated) affects approximately 13-15% of all American men. Most people who have not personally managed Low-T levels may be familiar with the hormone testosterone, but may not grasp the symptoms and prevalence of the condition. Read below to learn more about how this important hormone affects male and female physical development. 

What Is Testosterone?

A hormone found in both genders, testosterone is present in much higher levels in men than women. As boys mature during puberty, the testicles produce increasingly more testosterone. Many physical changes accompany this time period, including deepening of the voice, the presence of facial and body hair and increased height and body mass.

What role does testosterone serve?

According to Healthline.com, “testosterone stimulates sperm production and a man’s sex drive and also helps build muscle and bone mass.” Testosterone is responsible for red blood cell production and fat distribution throughout the body. It is also a required hormone for the creation of babies.

Within the ovaries, women’s bodies produce a fraction of the amount of testosterone that men’s bodies need. Known as a sex hormone, this hormone affects bone mass, reproductive tissues, growth and behavior.

What are the symptoms of low testosterone?

After age 30, the male body slows down production of the hormone and testosterone levels decrease every year thereafter. As levels continue to drop, men can experience fatigue, low sex drive and a decrease in muscle tone and mass.

Some of the physical changes associated with low testosterone are:

  • Increased body fat (especially around the mid-section)
  • Decreased libido or sex drive
  • Bone fragility
  • Exhaustion or malaise
  • Altered cholesterol
  • Lowered sperm count
  • Insomnia or sleep apnea
  • Hot flashes

Additionally, certain conditions like testicular cancer, COPD, obesity, diabetes, HIV, kidney or liver disease, or drug addiction can exacerbate the symptoms of low testosterone. If low testosterone levels are present in a patient, doctors will monitor hormone levels via urine or blood tests throughout treatment.

Early detection of Low-T: Watch for these symptoms

  • Note a sharp decrease in libido or erectile dysfunction

A dramatic decrease in sexual desire or difficulty maintaining an erection can be signs of low testosterone. Per Healthline, “Testosterone alone doesn’t cause an erection, but it stimulates receptors in the brain to produce nitric oxide — a molecule that helps trigger an erection. When testosterone levels are too low, a man may have difficulty achieving an erection prior to sex or experience spontaneous erections (for example, during sleep).”

  • Pay attention to your energy levels

Sudden moodiness, a lack of mental concentration or excessive fatigue may be attributed to low testosterone levels. You may notice that you are constantly tired, even though you sleep the same number of hours every night. Perhaps focusing on your work is growing increasingly difficult. Be sure to keep in mind that hormone levels can be at fault for the abrupt changes in your motivation.

  • Sudden weight gain or hair loss

Certain symptoms can have a variety of root causes. Weight gain and hair loss can be wrongly attributed to stress, however, in men over 50, low testosterone is often the culprit. Additionally, low testosterone levels can cause specific fat distribution patterns. One such pattern is known as Gynecomastia, which involves swollen or enlarged breast tissue. While this is not usually a serious medical issue, it can be frustrating or unpleasant for the individual experiencing the condition.

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 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 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

Five Tips For New Clinical Trial Participants

Clinical trial data helps researchers create new treatments and facilitates innovations in the field of medicine. These studies rely heavily on volunteers, and the data that researchers collect from study participants impacts the drug development industry.

Medications available to the general public face a rigorous testing and FDA screening process before they are made available to the mass market. Clinical study participants help researchers understand the effects of experimental drugs or medical devices, and thus help improve the modern selection of medicines available to the general population.

A few things all study participants should understand are:

1. Study lengths vary depending on study phase and protocol

All clinical trials adhere to a master plan – otherwise known as study protocol – which includes the study duration. For example, the clinical studies at OCRC range from just a few days to 6-7 months.

Typical clinical study lengths are as follows:

– Phase I trials typically lasts several months

– Phase II may range from several months to approximately two years

– Phase III make take anywhere from one to four years

– Phase IV trials monitor the drug safety and may be ongoing after a drug has been marketed

2. Understand risks and benefits associated with a clinical study

All clinical trials have some level of inherent risk. A few of the benefits may include:

– Medical expertise, free of charge

– Access to medicine or devices that are unavailable to the general public

– Providing scientific research that may lead to medicinal improvements

Make sure you are comfortable with all study requirements and expectations. It’s smart to have a few questions in mind that you can ask the medical staff at the clinic.

3. Clinical researchers recruit individuals with certain conditions or backgrounds

The average clinical trial criteria may include age, gender, race, current and/or preexisting medical conditions. Researchers may also have mandatory exclusions for a study, depending on which variables they are looking to isolate. For example, women have been excluded from recruitment for the low testosterone study at our clinic.

4. A variety of organizations may sponsor a clinical study

Funding for clinical trials may come from different organizations, both in the public and private sector. Large health maintenance organizations, the National Institute of Health and pharmaceutical companies are all frequent sponsors of trials. Learn more about what a sponsorship entails here.

5. You may receive an investigational drug or a placebo during the trial

It’s important to note that a percentage of clinical trial participants may receive a placebo medication. The primary reason why patients are not told which medication they are receiving is to avoid a human bias in the research findings.

Learn more about current studies at OCRC

We are committed to making all of our volunteers feel comfortable during their visit to our clinic. 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.

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

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

Who Are Clinical Trial Sponsors?

Sponsors play an important role in determining the viability of a clinical study. They oversee the overall study design, facilitate funding sources and develop beneficial procedures to help guide the study towards a successful outcome.

Sponsors are responsible for overseeing the study’s continued progress.

Clinical study sponsors may either be an individual or a pharmaceutical company, charged with overseeing various tasks that are critical to the success of the study.

Some of the responsibilities of a sponsor may include:

  1. Designing the study to address key research or medical questions
  2. Finding and hiring qualified study investigators
  3. Ensuring investigators are fully briefed on all data pertinent to the clinical study
  4. Monitoring the clinical study and verifying the trial is compliant with the protocol identified in the Investigational New Drug (IND) application
  5. Keeping the FDA, ethics boards or regulatory agencies abreast of any identified side effects, safety concerns or benefits of the investigational drug
  6. Ensuring budget adherence, managing investor expectations and communicating issues to stakeholders

A variety of organizations may sponsor a clinical trial.

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

  • Government agencies, such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA)
  • Private individuals, companies or organizations
  • Pharmaceutical, biotechnology and medical devices companies
  • Health care institutions, such as academic medical centers and health maintenance organizations (HMOs)

Funding sources may range depending on the study scope.

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

  1. Volume of participants
  2. Staff size needed for study completion
  3. Manufacturing of research materials needed
  4. Amount of patient compensation,
  5. Length of clinical study
  6. Approval status of the investigational drug.

According to Wikipedia, “the cost of a study depends on many factors, especially the number of sites conducting the study, the number of patients required, and whether the study treatment is already approved for medical use. “

Learn more about clinical trials.

OCRC sponsors and Contract research organizations, like Covalence, work hard to streamline our regulatory process, volunteer recruitment and data management capabilities. Our website explains the full nature of their specific contributions and responsibilities.

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. 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.