The changing landscape for clinical research.

The authors review the history of U.S. clinical research and identify the profound changes stemming from advancements in the biomedical sciences, the recent transformation in the organization and financing of health care delivery, and the increasing application of information technologies. They observe that the enterprise must reorganize to account for the changed landscape, but there is a lack of the data necessary to monitor change and determine the extent to which clinical research is successfully realigning and sustaining itself. The authors discuss the evolving definition, scope, and venues for clinical research, and review previous analyses of clinical research's difficulties and remedies proposed: shared responsibility in the financing of academic medicine, support by federal and private health insurers for routine costs of patient care in clinical trials, and strengthened collaboration between and among industry, academia, insurers, and government. The authors conclude by describing two major initiatives to foster clinical investigation in the new landscape. The first is the Clinical Research Summit Project, a convocation of representative stakeholders from the health care system with an interest in clinical research, whose charge will be to formulate a national agenda for clinical research that has the broad-based support of the stakeholders. Among the challenges of this undertaking are the needs to identify new and stable sources of support for clinical research infrastructure, assess the future workforce needs for clinical investigation, and devise new methods to ensure the continued vitality and account-ability of clinical research. The second is the Clinical Research Task Force, an initiative of the Association of American Medical Colleges (AAMC), which is already exploring and advising on how AAMC member organizations can best strengthen their capacity to support clinical research programs in the current scientific, health care delivery, and financial environment.