At The Polyclinic, the needs of the patient come first. Part of this commitment involves conducting clinical trials with the goal of helping people live longer, healthier lives.
Our trials are open to both established and new Polyclinic patients and include an array of medical disciplines, including allergies and asthma, cardiology, dermatology, endocrinology, gastroenterology, infectious disease, neurology, nephrology, rheumatology and urology.
Volunteering for a clinical trial is a personal choice. There are many things to consider before deciding to take part in a trial. The information below answers common questions about trials to help in your decision process.
- What is a clinical trial?
- What are the phases of a clinical trial?
- Why participate in a clinical trial?
- Who can participate in a clinical trial?
- What happens during a clinical trial?
- What happens after a clinical trial is completed?
Clinical trials are at the heart of all medical advances. Clinical trials look at new ways to prevent, detect or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.
An idea for a clinical trial often originates in the laboratory. After researchers test new treatments in the laboratory, the most promising are moved into clinical trials. Clinical trials are conducted in “phases.” Each phase has a different purpose and helps researchers answer different questions.
Phase I: Researchers test an experimental treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
Phase II: The experimental treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
Phase III: The experimental treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental treatment to be used safely.
Phase IV: After a treatment is approved by the FDA and made available to the public, researchers track its safety, seeking more information about its risks, benefits and optimal use.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they take part to help others and to contribute to moving science forward. Participants with an illness or disease also take part to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the study team. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
All clinical trials have guidelines about who can participate. Guidelines are based on factors as age, type of disease and medical history. These criteria are not used to reject people for any personal reason, but are used to identify appropriate participants and keep them safe.
The clinical trial process is determined by the type of trial being done. Each clinical trial is different, but all trials are carefully designed to safeguard a participants’ health and answer specific research questions.
All clinical trials conducted at The Polyclinic are approved and monitored by an Institutional Review Board (IRB) in order to ensure that the risks are minimal and are worth the potential benefits. An IRB is an independent committee that consists of physicians, statisticians and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected.
After a clinical trial is completed, researchers carefully examine information collected during the study before making decisions about their findings and any further testing.
After a phase I or II trial, researchers decide whether to move on to the next phase or to stop testing the treatment because it was unsafe or ineffective. When a phase III trial is completed, researchers examine data and decide whether the results have medical importance.
Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in news media, and discussed at scientific meetings and by patient advocacy groups before publication. Once a new approach has been proven safe and effective in a clinical trial, it may become the standard of medical practice.
Our goal is to ensure you feel comfortable and confident in your decision to participate in a trial. We are happy to answer any questions. Please contact us at: