Clinical trials are essential to the development of new medications and treatments. Because of clinical research, we now have effective treatment for hundreds of diseases. Survival rates for breast cancer, HIV, and prostate cancer have all increased in the last decade due, in large part, to research advances made by doctors and the participation of thousands of clinical study volunteers.
Before a medication is approved for use in the U.S. by the Food and Drug Administration (FDA), it must undergo three phases of clinical trials to assure its safety and efficacy. The FDA requires that a drug is proven safe and effective for an illness or disease before it is made widely available to physicians and patients.
Participating in a clinical trial is a great way to play an active role in your own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research. While in a clinical trial, participants are seen regularly by the researcher staff, which monitor their health and determine the safety and effectiveness of their treatment.
The same ethical and legal codes that govern medical practice also apply to clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB). The IRB is an independent review board which is usually composed of physicians, statisticians, and community advocates. The objective of the board is to ensure that a clinical trial is ethical and that the rights of the study volunteers are protected. The IRB also reviews the studies protocol to ensure the potential benefits significantly outweigh the risks involved in participating in a trial.
Anyone participating in a clinical trial in the Unites States is required to sign an informed consent form. This details the nature of the trial, the risks involved, and what may happen to a patient during the study. It also informs the patients of their right to leave the study at any time.
In some studies you may receive placebo, which contains no actual study medication. It is used in comparison to the treatment being tested to determine the treatment?s efficacy. Not every clinical trial uses placebos; some trials provide every participant with an active medication.
Clinical trials are sponsored or funded from both federal government (i.e. National Institutes of Health, the Department of Defense, and the Department of Veteran?s Affairs) and private industry (i.e. pharmaceutical and biotech companies). The sponsor of the research hires physicians to conduct the clinical trial. Trials can take place in a variety of locations, such as hospitals, doctors? offices, universities, or community clinics. Patients may also be compensated for their time and travel to participate in a clinical trial.
Each clinical study has a protocol which is the study plan that all clinical trials are based. This plan is designed to answer specific research questions. It describes what kinds of participants are needed, such as age, gender, or medical condition. The research staff will look at your medical history and study requirements to find out if you are eligible.
If you are interested in learning more about participating in a clinical trial, or if you are looking for a clinical research study that is right for you, please call our research staff at (251) 631-3023 or 1-800-844-LUNG (5864).