In FY 99 the Center for Biologics Evaluation and Research approved one vaccine and seven therapeutics. All of these advances came about in a scientifically and methodologically sound fashion and required the willingness of patients to participate in clinical trials. From a patient's standpoint, often the primary purpose of participating in a clinical trial is to get access to an important new treatment that is not commercially available. Patients clearly volunteer for altruisic reasons as well, reasoning that if a treatment does not benefit them directly, others will benefit from the knowledge gained. Particularly when a perceived blockbuster drug is developed and made available to clinical trial participants, patients will stand in line to get into a trial.
Clinical trials have both paybacks and drawbacks for physician investigators as well.
Being involved with discovery and development of new therapies is exciting as we all want something even better for our patients than most of today's treatments offer. But participation in a clinical trial means spending the extra time and dealing with the necessary but tedious detail of proper clinical trial conduct. We know that the attitude of a physician can have a great deal of influence on his or her patient's desire or willingness to pursue a clinical trial. If the physician seems negative about the clinical trial option, the patient may be less inclined to pursue the option. If the physician is too enthusiastic or optimistic, patients may receive a false impression about the promise or the benefits in participating.