that should be supported by someone else. However, society and the payers as society's representatives must recognize the value to all society of support for clinical research. The committee fears that a health care environment that focuses solely on costs or the effort to contain costs will increase the disincentive to invest in clinical research.

Current medical practice and health care rely on sound scientific principles. Clinical research into new therapies, diagnostics, prevention strategies, as well as outcomes assessment of current medical practice requires methods every bit as sophisticated as those required to isolate and clone genes. To develop a sound scientific basis for health practices, a thorough understanding of hypothesis testing and knowledge base in areas such as biochemistry, pharmacology, cellular and molecular biology, statistical methodology, economics, medical informatics, and the social and behavioral sciences is necessary. Design of clinical research without attention to preclinical studies is inappropriate.

Identifying and enrolling suitable patients into clinical research protocols is very time consuming. It is estimated that in many studies only 20 percent of the pool of apparently suitable patients are actually appropriate candidates (Friedman, 1987; Hunter et al., 1987; Martin et al., 1984). Thus, considerable effort is expended by the physician member of a research team who screens patients to enroll suitable subjects into research protocols. Many feel that this time commitment is underappreciated by other scientists and research administrators.

Although clinical investigators are commonly sought for academic departments, highly skilled and talented individuals who understand and can perform complex human studies are also needed by industry and government agencies (Shaw, 1992; Spilker, 1992). Career trajectories are vague, however, and clinical research funding appears tenuous when compared with the funding base for laboratory-based research (Wyngaarden, 1983). For many, the lengthy periods of training required to become skilled in providing high-quality health care conflict with the time demands of becoming outstanding researchers. High levels of educational debt, pressures to develop a unique academic practice and earn one's salary, obligations to family, responsibility to serve on numerous committees, and other commitments add to the pressures confronting junior faculty. On top of these pressures, faculty often find that the institutional paperwork required for different committees overseeing human research activities is virtually endless. Although these are just a few of the barriers and obstacles confronting individuals who choose to perform a human study in academic institutions, these and other problems affect investigators in both the federal government and the private sector.

The academic model in the past was the "triple-threat" faculty member who was expected to be an outstanding researcher, teacher, and clinician simultaneously. Because of the increasing complexity in all three realms, many



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement