Where do the ideas for clinical trials come from?
Ideas for clinical trials usually come from researchers. The first step is the development of new drugs or new uses for existing drugs, treatments and procedures. The first step is to test these in the laboratory and in animals. The drugs, treatments and procedures with the most promising results, established from the laboratory and animal studies, move into clinical trials that involve human participants. During a trial, more and more information is documented about the new drug, treatment and procedure, including its benefits and risks, and the optimal approach to treatment.
Ideas for clinical trials come from researchers working in a variety of settings. These researchers may be at hospitals or medical centers, universities, or may work for pharmaceutical or medical device companies. Initial research into a new drug or device or therapy is done in the laboratory and in animal studies. If the results of these initial studies are promising, a clinical trial is designed to further examine the safety and efficacy of that treatment or procedure.
The ideas for clinical trials often originate in the laboratory. Researchers develop a clinical trial protocol (the plan for a trial) after laboratory studies show promise for a new drug or procedure. The first clinical trials of a particular drug or procedure focus on safety (phase I). Later trials focus on whether the drug or procedure is effective (phase II or phase III).
