CLINICAL RESEARCH
TURNS OVER A NEW LEAF

Following is a reprint of the Executive Summary of the report and recommendations of an NIH committee convened to review and electrify clinical research at NIH. The committee was headed by Stephen Straus, NIAID. An implementation plan is now being finalized and will be published along with the entire "Report of the NIH Committee on the Recruitment and Career Development of Clinical Investigators" in the months ahead. The implementation plan will be published in a future issue of The NIH Catalyst.

Rapid changes in academic medicine and science are "bedeviling" clinical investigators nationwide, as Dr. Joseph Goldstein described recently in the first Shannon Lecture¹. At the NIH, the morale of clinical investigators has waned in recent years, and clinical investigators have begun to feel undervalued and undersupported. Nonetheless, NIH, with its Clinical Center and large research portfolio, has the ability to transcend these problems and to remain a bastion of clinical research excellence. Revitalization of clinical research is now a major priority of the NIH leadership and the scientific community.

The Committee on the Recruitment and Career Development of Clinical Investigators was formed to review the current state of clinical research and to offer specific recommendations to the deputy director for intramural research and the NIH associate director for clinical research to improve the recruitment, training, development, and tenure process for NIH clinical investigators. A three-month study by more than 40 senior NIH scientists led to this report's key findings and specific recommendations.

The Committee found that NIH clinical researchers are disheartened by a perceived decline in numbers of patients, increased obstacles to studying patients, and diminished respect for patient-oriented research as a rigorous and valuable discipline.

The Committee concluded that these complaints need to be addressed if NIH is to mount and sustain a broad and vital patient-oriented research program. Rising national interest in the evolution and success of clinical research and substantive new commitments at NIH, such as the construction of a major new Clinical Research Center, make this a propitious time for the rejuvenation of patient-oriented research.

The Committee identified four focus areas and made recommendations for addressing problems in each:

• Ongoing NIH clinical research efforts and projections of existing trends.

• The nature and adequacy of training and professional development for clinical researchers.

• The mechanisms by which clinical researchers are reviewed, tenured, and promoted.

• Recruitment of clinical researchers to NIH and how that process should be improved.

Problem areas identified by the Committee led to 32 recommendations designed to forge a full career track for clinical researchers at NIH, to secure stable support for clinical research activities, and to ensure an optimal environment for conducting clinical research at NIH. The essence of these recommendations is summarized below.

Personnel Mechanisms and Funding

Despite the beneficial application of Title 38 at NIH, personnel, salary, and funding mechanisms continue to generate powerful disincentives to the recruitment and support of the best clinical investigators.

• Under newly clarified authorities, tenure-track clinicians are covered under Title 42 appointments with a pay cap of $148,400. Despite this, ICDs have largely been restricting salaries to a noncompetitive $77,000. ICDs should raise the general salary cap for Title 42 appointees to $115,700 (Executive Level IV), with the possibility of exceptions to $148,400 (Executive Level I) for scarce medical specialties.

• Because all clinicians, including those in training, must be protected under the Federal Tort Claims Act, they must occupy full-time-equivalent (FTE) positions. With shrinking FTE allocations, there is a disincentive to sustain clinical training. This disincentive does not hold for postdoctoral training in basic laboratory science, where non-FTE personnel mechanisms, such as the Visiting Fellow and IRTA Programs, are an option. NIH should develop alternatives to the use of a full FTE for each clinician or otherwise ensure that all can be readily supplied with malpractice insurance.

• The current method of funding the Clinical Center leads to progressively higher per capita management fund costs as ICDs reduce their clinical efforts. This funding formula must be changed to eliminate this negative feedback spiral, either by providing a fixed allocation to the Clinical Center or taxing all institutes in proportion to the size of their intramural budgets.

• Staff clinician appointments are being used to circumvent the tenure process. More than half of staff clinicians surveyed spend less than the requisite 50% of their time on clinical service obligations; many of them control substantial independent budgets. Staff clinicians' appointments must be distinguished from tenured investigators', and both appointment mechanisms must be used properly.

Promotion and Tenure

Patient care is a necessary but time-consuming part of clinical research. In addition, clinical investigators may have training and clinical service obligations. All of these activities must be weighed in performance and promotion reviews.

• Memberships of the Boards of Scientific Counselors and Institute Promotion and Tenure Committees must be supplemented by individuals who actively conduct clinical research to evaluate NIH clinical investigators fairly. Similarly, clinical researchers must be included among those whose opinions are solicited regarding an individual's potential for tenure or promotion. Letters soliciting this advice must summarize the candidate's clinical and teaching obligations.

• Because clinical research may take longer than basic research and may require more collaborative effort, the five-year/eight-year rule should routinely be relaxed to provide clinical researchers up to eight years of postdoctoral training prior to competition for tenure-track positions. Largely patient-oriented researchers should be permitted up to eight years in a tenure-track position, especially for outside recruits. The total length of stay in nonpermanent positions at NIH, however, should not exceed 14 years.

• To ensure the fairest tenure review of clinical investigators, a Committee on Clinical Investigation should be formed to advise the Central Tenure Committee, analogous to the role played by the ad hoc Epidemiology Committee and the Computer Science and Engineering Committee.

Research Support and Training

The best clinical investigation occurs in an atmosphere in which high-quality medicine is practiced. The NIH associate director for clinical research must develop and employ measures for supplementing clinical consultative services where required and for ensuring high overall quality of clinical services. Clinical directors and chiefs of clinically oriented laboratories set the standards
for their junior colleagues. Unless senior staff exhibit and demand the highest standards, their junior colleagues may fail to do so as well.

• Bench research requires adequate space and budget and also the support of technicians and fellows. Clinical research likewise requires specific resources, not just clinical associates and nurses who manage inpatients. Many studies would profit by the availability of research coordinators and data managers. Some ICDs have appreciated this; many have not. NIH must develop more uniform support for both inpatient and outpatient clinical studies. The current transition to greater reliance on the outpatient clinic has not brought a commensurate shift in support services for that area.

• It takes years of practice and formal training to become adept at bench research. Clinical research is also complex, and proficiency in it requires training that is not available in medical schools and residency programs. NIH has developed a valuable Core Curriculum for Clinical Research that serves as an excellent introduction to the field. The NIH should now expand this program for selected M.D.s and Ph.D.s to provide in-depth training in ethics, trial design, epidemiology, informatics, etc. These programs could lead to advanced degrees in clinical investigation.

• Clinical research is not a solitary venture. The advancement of medical understanding, as well as the advancement of one's career and reputation, may warrant participation in extramural or multicenter collaborations. Current regulations that limit such activities should be abandoned or interpreted as narrowly as possible.

In addition to these 12 major recommendations above, the Committee made 20 others, both general and specific. The thrust of all these recommendations is to reinforce the excitement, sense of discovery, and unbounded opportunity that clinical investigators once enjoyed at NIH. Restoring a creative clinical environment will require attention to many more issues than this Committee could consider. It will take resources, imagination, leadership, and courage: the imagination to create new ways of translating bench science into practical medicine, the leadership to recruit, unite and inspire talented people, and the courage to cast aside bureaucratic obstacles and old habits that stand in the way.

Therefore, the final recommendation of the Committee is to establish a Clinical Research Revitalization Committee - consisting of scientific directors, clinical directors and other NIH clinical researchers - to provide advice to the deputy director for intramural research and the associate director for clinical research in implementing these recommendations and suggesting innovations to improve clinical research at NIH.

¹ The NIH Shannon Lecture, January 13, 1997, Bethesda, Maryland.

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