What are Clinical Trials?
Clinical Trials are research studies that involve people. All patients who participate in clinical trials are volunteers. They can choose to stop their participation in a clinical trial at any time. The main purpose of a clinical trial is to find a better way to prevent, diagnose, or treat a disease. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in very strictly scientifically controlled studies, and are required for regulatory authority approval of new therapies. In the USA, the approval of the Food and Drug Administration is required before new therapies can be used broadly in the marketplace. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions.
Why are clinical trials important?
Clinical trials are important to develop new treatments for diseases. Many of today’s standard treatments are based on the results of previous clinical trials.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
Who are the members of the clinical trials team?
Principal Investigator: The principal investigator, usually a doctor, is responsible for the design, development, and conduct of the clinical trial. He or she evaluates data and helps participating doctors manage the trial. You will continue to see your primary doctor if he or she is not the principal investigator.Research Coordinator: The research coordinator directs and coordinates patient care during a clinical trial, and is a good contact for patients who have questions. He or she will:
- Teach you about participation in the clinical trial
- Make sure the protocol’s instructions are followed
- Teach you about side effects
- Help manage clinical trial data
What are the different types of clinical trials?
Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening trials test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
What are the phases of clinical trials?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
- In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.