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P&S Journal

P&S Journal: Fall 1995, Vol.15, No.3
Clinical Trials: Recruitment, Sometimes Easy Sometimes a Thankless Task. The Adventures of Six Clinicians Recruiting Patients for Trials By Lynne Christensen;

With the advancement of medical science relying on new and better treatments, the role patients play in participating in the clinical trials necessary to test the safety and efficacy of new drugs, devices, and procedures cannot be overstated. The extensive rules and regulations researchers must follow to try new therapies in human subjects are well documented. But what about the more human side of recruiting patients to participate in clinical trials? What issues and obstacles do investigators face as they try to persuade patients to try a therapy that may or may not work and to accept the risks of being randomized into the placebo arm of a study?

From the researcher's perspective the most effective method for testing the efficacy of a new treatment is to compare it against an inactive preparation using similar patients where neither the patient nor the investigator knows whether the active treatment or the placebo is being administered. Thus, placebo-controlled, randomized, double-blind clinical trials have become the gold standard experimental modality. For conditions where an effective treatment is available, particularly for life-threatening conditions, the currently accepted treatment must be compared against an experimental modality.

In some cases, due to the nature of a therapy, the trial cannot be blinded. Researchers must constantly struggle to design studies in ways that will provide the greatest scientific accuracy, given the obvious constraints of treating human subjects.

The experiences of researchers working in diverse areas of Columbia-Presbyterian Medical Center reveal the many factors that come into play when recruiting patients for clinical trials. Interesting dif-ferences are seen in the ease or difficulty of recruitment, the effect of the availability of an experimental treatment outside of a clinical trial, and the enemy of time in some trials. While some researchers have lines of people hoping to enroll in a clinical trial, others can find no takers. While one researcher has too many patients willing to undergo sham surgery, another researcher can't find enough people to do nothing more than sleep.

Included are the stories of six clinical researchers at P&S:

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