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Clinical research translates basic science and discoveries into safe and effective tests, drugs, devices and procedures, eligible for approval by the U.S. Food and Drug Administration (FDA). Clinical trials are carefully designed and monitored studies intended to test and evaluate investigational drugs and treatment plans.
Many participants are patients whose own illnesses are not responding to standard treatment, and who hope that the study treatment – possibly an investigational drug, a device, or a combination of drugs or devices – will work better than standard therapy.
Other participants are healthy people who want to contribute to medical science and to help doctors and researchers find better ways to treat others’ illnesses.
Researchers follow strict ethical and scientific principles to ensure that patients are protected and that the results produced are valid. The study’s sponsor – a drug or device company – will draft a plan of how the study will proceed. This plan, or protocol, specifies how many individuals will be enrolled, how much drug will be used and when, what medical tests will be provided, and so on.
Evaluating new treatments involves some risks. Using a small group of volunteers, Phase I trials determine the best dosing and identify side effects. After a drug is shown to be safe and well-tolerated, Phase II and Phase III trials provide treatment to a larger numbers of patients with a specific disease. Side effects can vary, with dangerous complications possible.
To ensure that participants are not be exposed to unreasonable or unethical risks, every protocol is reviewed and approved by the sponsoring organization as well as an Institutional Review Board (IRB), which consists of health professionals, clergy and other community members. At Rochester General, the Office of Human Research Protection fulfills the IRB role.
Your doctor’s referral is not necessary, but anyone seriously considering a trial is urged to talk with his or her doctor and family about the potential benefits and risks. In order to participate, you will be evaluated by the medical staff conducting the study to determine whether you meet the medical criteria.
If you’re approved to join a trial, you should continue seeing your regular physician. Trial coordinators will consult with your doctor about how the study’s therapies are impacting you.
In most cases, the drugs and devices used, and any procedures for the study such as blood work, urine samples, x-rays and travel expenses are provided free to participants. Other costs unrelated to the trial may be covered by the patient’s insurance company or Medicare. Be sure to get a full accounting of costs before committing to a trial.
Each phase of clinical research is designed to gather specific information about the study drug, device or treatment.
The National Institutes of Health produces a booklet – “What Are Clinical Trials All About?” – that guides potential participants in deciding whether to participate, and encourages that individuals ask the following questions:
The following organizations provide additional information: