Who Oversees Clinical Trials?

Clinical trials are carefully conducted studies—using human volunteers—which are used to test potential medical treatments with an end goal of receiving an FDA approval for usages in a wider population. Any and all medical breakthroughs currently being used have, at some point, gone through the close observation during the clinical trial phases process. Because these treatments are being used on real subjects, it is important that these clinical trials are conducted in safe, ethical ways.

What are clinical trial regulations?

Before clinical research ensues, it must first be approved by an institutional review board (IRB). When conducting clinical trials, researchers should maintain communication with their study participants. Before volunteering to participate in a clinical trial, be sure that you are able to answer all of the important questions and that you know exactly what to expect. These should be laid out clearly in an informed consent form, which includes a summary of the clinical trial, treatment procedures and schedules, and risks and benefits. It will also lay out all of your rights as a volunteer, including the right to leave the study at any time.

How are clinical trial regulations enforced?

A Data Safety Monitoring Board (DSMB), which is a group of research and study topic experts, is required for all National Institutes of Health phase III clinical trials, in addition to earlier phase trials which involve more high-risk treatments. The DSMB reviews clinical trial data for any safety issues or differences in results among certain groups. Some trials may also be stopped early by the DSMB if they are causing harmful effects or revealing patient risks.

What is a Principal Investigator?

A Principal Investigator (PI) is the person in charge of conducting a clinical trial. The PI is responsible for ensuring that the study is following all regulatory requirements and meeting the international recognized standards for Good Clinical Practice (GCP). The PI is also responsible for making sure that all volunteers receive appropriate medical care related to the clinical trial.

What does it take for a study to become FDA-approved?

Before beginning a clinical trial, researchers must first submit an Investigational New Drug (IND) application to the FDA. This application should include data about side effects that may cause harm, manufacturing information, clinical protocols, and any prior human research data.

The FDA may be involved at any point in the drug development process—before completing an IND application, during the study (for guidance), and after the study to assess results. Developers may ask for help at any time, but are not required to take the FDA’s advice.   FDA-approval of the medical treatment itself takes place within a structured framework including analysis of target condition and currently available treatments, evaluation of benefits and risks from clinical research, and strategies for managing risks.  How can I learn more?

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

What Is the Placebo Effect?

“I’m a Cub Scout Camp Leader. When the kids start crying and want to go home, we just give them ‘homesick medicine’,” reads a submission on PlaceboArchive.org. “The kids always feel better within 15 minutes. The medicine is Tic-Tacs.”

“I was cutting onions one day, appreciating my contact lenses as they keep me from tearing up,” reads another submission. “After about a minute, I realized that I didn’t have my contact lenses in… I started tearing up within five seconds.”

The Power of the Mind

Our minds can do incredible things—they can even influence the ways our bodies respond to different situations. Similar to the above situations, many of us have likely experienced everyday examples of placebos: anything that seems to be a medical treatment, but isn’t. This phenomenon, called the “placebo effect,” is a significant part of clinical research.

While there are as many types of placebos as there are methods of medication, what all placebos share in common is that they do not contain any substances which affect health or wellbeing. In fact, many placebo pills are simply composed of sugar.

Why Use Placebos in Clinical Research?

Placebos, often used in studies of medical treatments, are used in clinical research as a controlled variable to test the effectiveness of said treatments. Volunteers in clinical trials will often be divided into groups; one group would receive the treatment in question, and the other would receive a fake treatment—the placebo—without knowing which one they are receiving. Researchers can then accurately compare the results of the experimental drug with the results of the placebo. If they both have the same reaction, this generally means that the drug is not effective.

The Placebo Effect
Ideally, volunteers in clinical trials would have no response to placebos, thus being able to determine the effectiveness of a studied drug with full accuracy. However, people can—and often do—have responses to placebos. One theory is that the placebo effect occurs because of a person’s expectations. If a volunteer in a clinical trial believes they are receiving a studied drug, they will likely expect the drug to do something. That person’s body will then be influenced to create similar effects to that of the actual drug.

The Placebo Effect: Helpful or Harmful?

For years, the placebo effect was considered to be an obstacle to overcome in clinical research. However, attitudes have evolved and researchers are looking into ways to utilize the placebo effect to its fullest potential. While the placebo effect may not speak directly to the effectiveness of a studied drug, it does speak to the complexity of our brain and body chemistry; the expectations which cause the placebo effect may involve genuine changes in brain chemistry, which cause a physiological reaction.

The placebo effect has opened doors to further research on the brain: if expectations of a medication can cause both positive and negative physical reactions, what else can our brains do?

Learn More About Clinical Studies

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

A Day in the Life of a Clinical Study Participant

Clinical trials are vital to the medical advancement process and to the development of new treatments. Clinical research participants get to play an active role in the development of modern medicine and health care. Incredibly, an experimental, life-saving treatment administered to a volunteer could one day be consumed by millions of Americans.

Take a deeper look into the clinical trial experience with our in-depth explanation of what goes into study participation.

What does it mean to be a clinical study participant?

Clinical studies are conducted with human volunteers in order to analyze the effectiveness of experimental new treatments. The study participants will receive medical care at health facilities for the duration of the trial and will receive access to new medical treatments before they are widely available to the public.

The number of desired volunteers and the length of the trial depends largely on the phase of the clinical study—this could be for weeks, months, or even years. Study organizers will always disclose this information upfront, as volunteers must be available for the duration of the time period.

What kind of clinical studies can I participate in?

Any health care treatments and medications you have heard of came to fruition after extensive research through clinical studies. This means that clinical trials cover a wide range of topics:

  • Intervention studies: Are there better treatment methods than those currently available?
  • Prevention studies: How can certain diseases and conditions be prevented?
  • Diagnostic and screening studies: Are there more effective ways to diagnose diseases?
  • Behavioral research: Which behavioral traits are related to a specific diagnosis?
  • Quality of life studies: How can the quality of life of those diagnoses with diseases/medical conditions be improved?
  • Observational studies: How can the health of individuals change over time?

Each study has different guidelines and eligibility requirements. If you are interested in joining a specific study, you must first find out if you meet the “inclusion criteria,” or factors that allow participation in the study. Some studies require healthy participants, while others seek those with specific diseases and/or medical conditions.

How does participating in clinical studies affect day-to-day life?

Because clinical study topics range so vastly, day-to-day protocol is also unique to each study. Before joining a study, make sure you are well-informed, and that you have asked yourself the following questions:

  • What are the possible risks involved?
  • What are the possible side effects? How severe are they?
  • How much time and energy would be spent with complex dosage schedules and/or frequent trips to the study site?

What do other clinical study participants think of their experiences?

According to Forte Research, only about 10% of Americans have participated in clinical studies. While about 95% of those clinical study participants said they would consider participating in another clinical study in the future, only about 88% of participants talk about their experience after the study concludes.

It’s possible that this is due to lack of public appreciation, a desire to keep health issues private, or a lack of immediate study visibility (as it often takes years for clinical research results to become public) resulting in a loss of interest. 

What is HIPAA?

HIPAA, or the Health Insurance Portability and Accountability Act, is a law designed to protect patient and participant privacy pertaining to medical records and other health information.

How can I get started?

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

You can also visit ClinicalTrials.gov and CenterWatch.com for clinical trial information in different locations across the country. Additionally, your doctor and/or community hospital may be involved in clinical trials and can advise you on which one may be the right fit for you.

Clinical Research FAQ

Clinical Research FAQ 

If you are new to the world of clinical trials, the terminology and procedures can be unfamiliar and even intimidating. The good news is that every medication that undergoes a clinical trial has been shown to be safe during extensive testing in preclinical trials (animal studies) To further explain the clinical research process, we’ve assembled some simple questions and answers to walk you through how it works.

What are clinical trials?

Clinical trials are studies conducted by clinical researchers in order to advance medical knowledge and develop new treatments/medications. Clinical trials, or research conducted through human volunteers, explore a variety of topics ranging from the use of daily vitamins to cancer treatments.  

How long are clinical trials?

The length of a clinical study varies according to what is being studied—this could range from several weeks to several years. Depending on the phase of the study, a participant may or may not be part of the entire study. Participants will always be informed of length of the study and ideal participation time prior to enrolling.

What are the benefits and risks of participating in clinical trials?

Advances in medical technology would be impossible without clinical trials; clinical trials are impossible without volunteers. Participating in a clinical trial can make you part of a process that will help to improve the health of millions.

Before enrolling in a clinical trial, potential participants are evaluated to ensure that they meet the volunteer requirements (age, gender, location, medical history, etc.). They should also discuss clinical trial involvement with their usual health care provider to make sure there will be no conflicts with ongoing medications or treatments.

Is there compensation?

Whether or not you get paid—and the amount you receive—for participating in clinical trials depends on the study being conducted. Factors include participant’s time and energy spent on the trial, amount of traveling associated and the phase of the study. Rates are generally determined by the study’s principal investigator 

What are my rights as a clinical trial participant?

Informed consent is a process used by researchers to communicate with potential participants about the study. This also provides participants with all necessary information, ensuring that the participant understands what the trial entails, and stresses that participation is always voluntary.

If you are thinking of joining a clinical trial, it doesn’t hurt to take the time to get answers to some important questions.  

What is a placebo?

Placebos are harmless, inactive “medications” that are sometimes used in place of the real medication. Participants aren’t told whether the treatment they are using is a placebo or not—this is to maintain consistency with the control and dependent factors by preventing bias or imagined results on behalf of the participant.

What is randomization?

Randomization is when treatments are selected by chance, not choice, in order to prevent the results from being skewed. If the researcher or participant is allowed to choose who receives a new treatment, the results may be influenced, subconsciously or not. Randomization reduces the occurrence of bias; without it, a doctor may inadvertently choose a patient that they think is more likely to benefit from the treatment. 

Where can I find clinical studies?

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

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.

How Does Clinical Research Help Improve Disease Management?

How Does Clinical Research Help Improve Disease Management?

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

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

Clinical Research Helps Improve Disease Prognosis

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

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

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

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

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

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

Consider Being a Part of a Clinical Trial

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

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

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.

Key Risk Factors for Liver Cancer

Key Risk Factors for Liver Cancer

Over time, behaviors like smoking, heavy drinking and poor health take their toll on the internal organs. The liver is a highly resilient organ, but recurring abuse does take a toll. Below, we examine the progression and risk factors associated with liver cancer.

Cancer often develops prior to liver infection

One important thing to remember is that cancers that appear in the liver often originate in other parts of the body. Many times, the liver becomes infected long after other body tissue. According to the Canadian Liver Foundation, “Most cancers of the liver begin elsewhere in the body and are spread to the liver. These cancers are not curable through liver transplantation. Tumors that originate in the liver are usually detected in an advanced stage.”  

Risk factors associated with liver cancer

Certain risk factors are inherent, like your age, gender or your family’s background. Other risk factors like smoking, alcohol consumption, stress and/or exercise levels can be modified to reduce the risk of liver cancer. It should also be noted that just because an individual possesses these trails or factors, that does not mean they will experience the condition.

Here are a few known risk factors for liver cancer:

  • Cirrhosis: Repeated liver abuse, known as cirrhosis, is the second most common cause of liver cancer. Long-term cirrhosis may accompany other serious health problems like malignant tumors, fluid buildup, jaundice and high blood pressure.
  • Gender: Males are known to be more susceptible to the condition than women.
  • Hepatitis B or C: Viral infection of the liver is the most commonly occurring risk factor for liver cancer. These infections are frequently correlated and are responsible for a significant amount of worldwide liver cancer cases. People with hepatitis C are almost twice as likely to experience liver cancer than other types of hepatitis. There are multiple types of hepatitis, but both hepatitis B virus (HBV) and hepatitis C virus (HCV) can cause cirrhosis.
  • Nonalcoholic fatty liver disease: Fatty liver disease affects about 25% of the U.S. population, according to the National Liver Foundation. Approximately one-fifth of individuals with fatty liver disease go on to experience liver cancer. According to Medscape, “from 2004 to 2009, the annual increase in hepatocellular carcinoma in fatty liver disease patients was approximately 5%.”
  • Race: Within the U.S., American Cancer Society’s data shows that “Asian Americans and Pacific Islanders have the highest rates of liver cancer, followed by American Indians/Alaska Natives and Hispanics/Latinos, African Americans, and whites.”

If you exhibit multiple liver cancer risk factors, be sure to speak with you doctor about liver disease. You may also consult with the doctor at OCRC if you meet our liver study criteria. 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.

 

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.

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.

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.

The Four Phases of Clinical Research

Clinical trials are comprised of a series of phases, focused on comprehensively investigating an experimental treatment or medication’s side effects, effectiveness and safety. All medications or treatments must sequentially complete the clinical trial phases before moving on to FDA consideration for release to the general public.

When an experimental medication comes into a clinic, researchers assess its benefits and shortcomings. Some of the questions researchers are looking to answer may include:

  • How does the medication affect the participant’s body?
  • Do the benefits of the medication outweigh the side effects?
  • How does this medication react when combined with other prescription medications or over-the-counter treatments?
  • How does this medication affect a certain segment of the population?
  • What is the recommended dosage recommendation breakdown?

The breakdown of the four clinical trial phases is as follows:

Phase I: Initial small group testing to determine safety and dosing, and identify side effects

During this phase, researchers pay particularly close attention to the way study volunteers metabolize the administered medication. Phase I trials are designed for a relative small number of healthy participants and typically last a few weeks to several months. Certain clinical trials may call for volunteers who are impacted by a specific cancers or conditions.

Phase II: Further safety and efficacy evaluation on a larger group

Phase II of a clinical trial may span several months to approximately two years. During this period, researchers evaluate the wellbeing of a group of volunteers who receive the experimental medication against a “control group” who received a placebo. This is done to ensure statistically valid data and to help rule out alternative explanations for study results.

Phase III: Large group testing to determine safety, effectiveness, efficacy and monitor side effects 

According to the U.S. National Library of Medicine, the primary goal of phase III is “to confirm the experimental medication’s effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.” Phase III studies may last anywhere from 1-4 years and offer the FDA and manufacturers a deeper understanding of the benefits and caveats of a treatment.

Phase IV: Post-market studies focused on long-term usage side effects

Phase IV trials, otherwise known as post-marketing surveillance, occur after the experimental drug has been approved marketed. This stage offers manufacturers further insight into the medication’s comparison against other treatments currently on the market. Phase IV trials also serve to highlight the long-term benefits of the treatment in a much larger patient population size.

Help shape the future of modern medical treatment

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 6-7 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.

fda-drug-approval-process
Learn more about clinical trials at clinicaltrials.gov.