Cultivating a New Generation of Clinical Investigators
Recruiting smart, highly motivated physicians and helping them become outstanding clinical researchers—those are the goals of Baylor’s Clinical Scientist Training Program. VIICTR.org spoke with Ashok Balasubramanyam, M.D., professor of medicine and molecular and cellular biology at Baylor and the program’s new director, about what it takes to cultivate a new generation of clinical investigators.
What is the Clinical Scientist Training Program (CSTP) and what are its origins?
Dr. Morey Haymond, a pediatric endocrinologist at Baylor, started this program through a grant from the National Institutes of Health (NIH) about 14 years ago to train clinicians who are interested in research but do not have the skills or tools to conduct the kinds of research that can be funded. He recruited Dr. Olga Watkins, who continues to oversee important administrative and educational aspects of the program. Dr. Jesus Vallejo, professor of pediatrics, is the new co-director.
All program candidates are required to prepare a K-type NIH-style grant application, which is a mentored career development award. K Awards are highly competitive, and earning one gives the recipient a prestigious and productive start to an research career. Clinicians who obtain these awards work under a mentor and receive theoretical and practical training in clinical research. Many Baylor trainees have gone through the CSTP, and many have subsequently received K Awards or NIH Merit Awards.
Give us an overview of the CSTP—for example, describe what it entails and the type of commitment it requires.
The program has three tracks with different levels of commitment and goals. There is the Certificate of Added Qualification (CAQ) track, a 1-year program typically taken by second-year fellows who have completed the clinical portion of a training fellowship that also requires a year of research. The track requires a 1-month intensive course called “Fundamentals of Clinical Investigation” and a biweekly seminar with the CSTP faculty during which participants present and hone their research proposal. Candidates do not complete a research project or present a thesis, but they do learn how to write a grant proposal. This track is excellent for clinicians who are already completing an independent project as part of their clinical fellowship but want additional training to receive the CAQ certificate.
The next level is the master's degree program, which requires a 2-year commitment. Candidates for this track are more likely to be senior fellows who, in addition to having completed a clinical fellowship, would also have started a research project and want to expand it. Their Baylor department or center must be permit them 75 percent protected time (meaning that they have a salary source that is not more than 25 percent clinical) and be able to provide the resources to conduct the research project. To receive a master’s degree from Baylor’s Graduate School of Biomedical Sciences (GSBS), candidates must earn 30 credits in didactic work, with both core courses and additional electives in the areas that support their research interest. They must also complete and defend their final thesis, and complete a K Award-level grant proposal.
The third track results in a Ph.D. degree from the GSBS. This track includes candidates who are already junior faculty members who have the support of their mentors and departments to spend the 3 to 6 years it takes to earn the advanced degree. The number of didactic courses in this track are similar to those for the master's program, but the research project is more advanced. Ph.D. candidates must publish several papers in addition to completing and defending their thesis and writing a K Award proposal.
Who would most benefit from this program?
A typical candidate for the CSTP is an energetic, intelligent, academically oriented physician who has spent 4 to 8 years completing a clinical internship, a residency, and part of a subspecialty fellowship and who is interested in clinical investigation rather than basic research. For these people, the CTSP is an ideal program.
We have also physicians in the program who have conducted basic research and have decided that their real passion is translational research. These physicians, however, have never been exposed to the clinical aspects of research in humans. What makes them wonderful candidates is that they already understand scientific methodology, and many of them have already written papers and grant proposals. Although the scientific approach is not new to them, they need to learn how to conduct clinical trials and patient-oriented research. These physicians are the minority of applicants. The majority are outstanding clinicians who have never conducted clinical or basic research in the past and seek fundamental scientific training from scratch.
What is the selection process for potential candidates?
Program applicants are selected based on certain criteria. First, they should show a serious intent to pursue a career in clinical research. Second, they should have a mentor and a clear plan that details how the candidate and mentor will work together, the type of research the candidate will conduct, and the resources that will be available to the candidate. Finally, if the candidate is entering either of our graduate degree tracks, the mentor must confirm that the candidate will have 75 percent protected time for research.
What types of research projects are typically generated in the program?
One kind of project is health services oriented, with a focus on outcomes research. A second type is clinical trials, often in the area of cancer or infectious diseases. A third very large group of projects are considered translational—carried out by candidates whose mentors have completed sufficient basic research to yield a discovery that needs to be investigated in humans. That investigation could either be from careful longitudinal analysis of patients, or it could be sampling of blood or tissue, or it could be a drug trial with some mechanistic component to be investigated. As you can imagine, all three of these kinds of clinical research have a very heavy analytical component. So regardless of the kind of research candidates wish to pursue, each candidate must study biostatistics, study design, ethical conduct of clinical trials, data analysis, and develop a comprehensve understanding of a sound research project.
As the program’s new director, are there any changes in store for the CSTP?
We have designed several new courses for the 2014–2015 academic year. These include biostatistics, drug discovery, and a course on “omics” that, like genomics, has an information technology slant and shows how to use information derived from large databases of gene sequences, proteins or metabolites. We are also adding a scientific commercialization course, because we understand that many clinical scientists will not necessarily become pure academics but, rather, will want to bridge the gap between academia and industry.
Despite these changes, our overall goal remains the same—to develop a cadre of superbly trained clinical investigators who, as physicians, conduct outstanding clinical research. It would be gratifying to see that every physician who pursues training beyond the 1-year CAQ program will write a successful K Award proposal. To me, this is the real mark of success—to train clinicians who are passionate about clinical research and give them the first big boost in launching their academic careers.
To learn more about the Clinical Scientist Training Program, visit: https://www.bcm.edu/education/programs/clinical-scientist-training/