Clinical trials are the testing of new treatments in humans after extensive laboratory research has been completed. Clinical trials find better ways to treat a specific disease and are a critical step in the development of new medications to treat diseases. Advances in medicine and science are the direct result of new ideas and approaches developed through research.
A clinical trial is a research study in human volunteers to answer specific questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Intervention trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
Each clinical trial is carefully designed to evaluate if these new therapies are safe to give to patients and determine how effective they are in preventing or treating disease. Before a new treatment is approved for general use in the United States, clinical research must be conducted to prove it is safe and effective.
Research studies may be paid for by pharmaceutical or biotechnology companies, the federal government, or foundations or associations who select physicians that are qualified to conduct clinical trials.
All research studies involving human participants are reviewed by an Institutional Review Board (IRB). This board is a committee of local researchers and lay people that volunteer to review research studies that involve human participents performed at individual institutions. The purpose of this review is to ensure that the rights and welfare of the subjects who are willing to participate are adequately protected.
Participants can include people with specific disorders or diseases. You should ask your doctor if there are any available research studies for your condition. There are also multiple research studies that require otherwise healthy participants.
Why are Clinical Trials Conducted?
Clinical trials answer specific scientific questions such how to prevent, diagnose, treat, or study the psychological impact (ie, quality of life) of a particular disease in humans.
Who Offers Clinical Trials?
Usually a physician who is interested in research at a university, hospital or private practice offers clinical trials. The physician is called an investigator and a research nurse coordinates trials.