Clinical trials and the community physician

Further important advances in cancer treatment, and the development of regimens with fewer side-effects, may largely depend upon the subtle manipulations of available agents and comparison of results only possible in large numbers of patients. More than 80% of all cancer patients are treated within their own communities, and the opportunity to increase the overall cure rate significantly above the current estimate of 41% depends upon our ability to conduct clinical trials in these communities. A variety of models have evolved for the integration of the community physician into clinical cancer research. Abundant evidence exists that the quality of clinical research data generated by the community physician is usually not different from that of data generated by university hospitals or Cancer Centers. While the protocol which provides instructions for the clinical trial is often a formidable document, newly developed computer systems permit a highly simplified interaction between the physician or nurse and the office computer terminal. The process of randomization, which is often essential to eliminating bias in studies comparing treatments, has been difficult for community practitioners to accept. A new statistical technique, pre-randomization, may solve this problem. Even where patients do not formally enter a clinical trial, the introduction of protocols into a practice provides the benefits of all known technology. Thus, community participation in clinical research is a superb method for delivering optimal patient care.