it is declining—less than half, in 2003-2006. Finally, 38 percent of principal investigators who participated in clinical trials between 2000 and 2005 did not return to conduct another clinical trial within the next 3 years.

Cultural Obstacles

More than 90 percent of trial delays are caused by overambitious timelines and difficulties with patient enrollment. Timelines turn out to be too optimistic in large part because investigators encounter administrative and institutional hurdles, such as protracted budget negotiations, slow IRB review and approval, and, as noted, poor patient recruitment. At

BOX 8-1a
Building Connections Between Community Physicians and Clinical Trials: Challenges and Potential Solutions

Community physicians play a key role in the clinical trials enterprise. In discussing the need to bring clinical trials to where the patients are, workshop participants noted that community physicians are important stakeholders and partners in conducting clinical trials. Community physicians can engage in a number of points across the lifecycle of a clinical trial—from the generation of research questions, service as the principal investigator, facilitating the recruitment and retention of patients, and community-focused dissemination of trial results. Panelists and workshop participants discussed a number of challenges and potential solutions to facilitate the development of effective connections between community physicians and researchers conducting clinical trials in academic medicine.

Challenges discussed at the workshop for community physician engagement in clinical trials:

•   Significant time constraints due to busy clinical practice and the concern that it will take the physician extra time to locate an appropriate clinical trial for a patient and explain the value of the trial to the patient.

•   Information overload (e.g., a physician receiving “100 emails per day” concerning clinical trials, but none of those coming from an entity or individual the physician knows or trusts).

•   Failure of communication with researchers throughout the lifecycle of the trial— including concern that physicians will be caught by surprise or will be unaware of treatments and side effects their patients experience as part of the trial.

•   General lack of physician knowledge as to the array of clinical trials available and how the trial might help their patients.

•   Heterogeneous patient mix and a diversity of patient medical needs that may or may not be solved or improved through care received in a clinical trial.



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