The outlook for clinical research: impacts of federal funding restraint and private sector reconfiguration.

Accustomed to congressional and industry support, patient-centered clinical research is at a crossroads in 1995. Forced to look into the next century by the seven-year budget cycle selected by Congress, its path seems hindered by threatened cuts in funding for the National Institutes of Health (NIH), cost pressures on private-sector organizations that support research initiatives, and market restraints on the academic health centers that traditionally have served as research bases for many clinical investigators. Assuring public and private financial support for clinical research has become an important topic on policy and industry agendas, as has the need to sort out the roles of the NIH, academic health centers, managed-care plans, and pharmaceutical firms in backing and conducting research. The very character of clinical inquiry seems to be reshaping itself amid conflicts over basic versus applied research, ongoing versus new investigations, and scientific discovery versus product development. How these issues are approached--let alone resolved--is significant not only for the future of clinical research but also for the health of the public. The author discusses these issues and concludes with a list of specific questions that must be addressed in confronting policy issues of clinical research.