Present advances in molecular medicine are providing enormous scientific opportunities. Never before has the bench/bedside interface been more exciting and productive and never before have clinical trials been more promising as new products of the genetic revolution flow from pharmaceutical and biotechnology companies. Despite the development of these opportunities for clinical research, it has been recognized that there is a crisis in clinical research centering around the fact that insufficient number of individuals are being trained for careers in clinical research. The Institute of Medicine and the NIH Director's Panel of Clinical Research called for a multifaceted and concerted effort to address this issue by developing clinical research training programs, thus encouraging more of the best and brightest young people to pursue careers in clinical research. The objectives of the new or modified programs were to generate a cadre of superb clinical or physician scientists and to provide them with the methodologic, quantitative, creative, critical and intellectual skills to perform first class research; to combine in one award in depth formal didactic training, including core and elective curricula tailored for their specific scientific interests, and mentored clinical research projects(s); and to provide adequate stipends and resources. An important aspect of the NIH response was the creation of the K-30 Clinical Research Curriculum Award (CRCA). It was clear to the NIH as well as to the faculty who train clinical fellows that merely adding a special clinical research training component to present clinical training programs is problematic. The added component would significantly lengthen the overall time required to complete the clinical program, and thus not be practical in terms of funding nor attractive to potential trainees in terms of time. Moreover, there are not enough qualified mentors to supervise such training. Thus the NIH, through the CRCA Award Program has developed more imaginative ways of improving training of clinical investigators. This award was offered only twice (1998 and 1999). Tulane University was one of the universities awarded a 5-year CRCA.

The Tulane CRCA Program is a new, 2-year graduate training program in clinical research jointly sponsored by Tulane Schools of Medicine and Public Health and Tropical Medicine that was funded as of September 30, 2000. Tulane's K30 Program was developed to identify, recruit, and train the best possible post-doctoral candidates from diverse academic backgrounds including medicine, pediatrics, surgery, infectious disease, pharmacy, and biomedical engineering and prepare these individuals to become highly skilled and independent clinical investigators who can eventually be successful in applying for NIH grant support. The Program will bring together trainees from Tulane Medical School, Tulane School of Public Health and Tropical Medicine, Tulane Department of Biomedical Engineering and the Xavier University College of Pharmacy. As part of the Program, a Master of Science in Clinical Research degree has been established.

The goal of Tulane University's CRCA Program is to identify, recruit, and train the best possible candidates from diverse academic backgrounds including medicine, pediatrics, surgery, infectious disease, pharmacy, and biomedical engineering. The further goal is to prepare these individuals to become highly skilled and independent clinical investigators who can eventually be successful in applying for NIH grant support. For the trainees, this award will allow for an increase in experience and training in clinical research; and for the institution, this will increase the opportunities to develop competent investigators in clinical research that will be able to compete successfully for grant funds that are presently less than that available for laboratory research. It is fair to say that before the development of the CRCA by the NIH, the number of programs that could provide formal training in clinical research for qualified and interested individuals was limited.

Tulane University is well positioned to implement a comprehensive multi-disciplinary clinical research curriculum that will meet the requirements of the CRCA by offering specialized clinical research training within the time frame of a clinical training program.

The leadership and faculty of the CRCA has the collective experience, commitment and enthusiasm to make the program a successful endeavor and are in agreement that our program should be of the highest possible quality and a national model for excellence. The CRCA faculty have over $25 million in total research funding including grants and contracts from the NIH, as well as from other federal agencies (e.g., DHSS, CDC, DoD, VA) as well as from industry and foundations.

In summary, the proposed CRCA Program at Tulane offers the formal course work and mentoring necessary to provide trainees the strongest possible start in their preparation for t a successful clinical research career.