As we attempt to train and encourage new generations of clinical investigators, with a focus on research that benefits and utilizes patients, I thought it might be useful to get a new generation perception of what exactly is clinical research or, in our context, patient‐oriented research (POR). I currently work at a medical school‐affiliated teaching hospital, with trainees at all levels and active fellowship programs. There is a local IRB for the entire medical center that reviews 12–15 protocols per month from all specialties, and there is an annual institution‐wide resident and fellow research fair, that is widely supported. On site, there is limited laboratory‐based research.
I conducted a nonscientific, nonstatistically tested survey of my current colleagues in medicine, including faculty (10), fellows (10), and residents (15). The following questions were asked:
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1
Is patient oriented research important to the advancement of your specialty?
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2
Have you participated in patient‐oriented research, and at what level of development—medical student, resident, fellow, faculty?
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3
Is the ability to conduct patient oriented research a factor in choosing your current employment?
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4
Are opportunities for conducting patient oriented research important considerations for future employment opportunities?
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5
What obstacles exist in the current medical environment for participation in patient oriented research?
Regarding Question #1, all uniformly agreed that this is important. Answers to the other questions were more complex. All said they had participated in research. From the faculty side, some had participated in research during training, but no longer were participating. Others continue to conduct patient‐oriented clinical trials. The types of faculty research included drug development clinical trials, database epidemiology, and investigator‐initiated therapy in critical care and anesthesiology. One faculty member was collecting pedigree data to derive exploratory molecular markers of genetic predisposition for disease. They all expressed a commitment to continuing a research path along with clinical care, but expressed concern that the current environment is not friendly to clinical researchers, and there is little to no funding for exploratory research.
Concern was expressed by both junior and senior faculty that the competition for funding limits both new and experienced investigators, and does not encourage exploratory ideas. Especially among senior investigators, there was concern that IRBs are becoming more and more restrictive as legalities dominate research concerns in studies related to human subjects. Senior investigators also indicated that pharmaceutical industry‐driven drug development studies are designed for drug approval, and may not ask the interesting additional questions related to drug mechanism and ancillary events. This situation cannot be modified by individual investigators when the sponsor controls the studies. There is limited partnership with academic patient oriented research programs to address both types of research questions.
Junior investigators were concerned about getting a start, obtaining mentoring that provides job security, and obtaining funding for additional research efforts. As more and more emphasis is placed on clinical reimbursement as the driver for a clinical faculty position, the junior investigator feels pulled more toward clinical care. This is a major concern when thinking about innovative, time consuming, patient‐oriented research and career development.
As a faculty member of the AACR/ASCO Clinical Trials Workshop for several years, the major complaint I heard from participants, many from what we would consider major academic centers, was lack of mentorship at their local institution. Many faculty are apparently too busy and too encumbered to mentor! More clinically oriented institutions like mine often lack the infrastructure to support patient‐oriented research.
Of interest, the residents and fellows had similar respect for research, and similar concerns about funding and mentoring, although most of them were anticipating entering a private practice environment. This is likely a reflection of the clinical nature of our training program. Many said that they have participated in clinical research—as residents and fellows, and eight of them had submitted posters to our research fair. However, protected research time is limited to only a few weeks. One resident had participated in collecting patient survey data to evaluate quality of life among patients undergoing bone marrow transplantation, and this was ongoing throughout his middle year of residency. Others have entered patients into clinical trials during training, or have treated research subjects by writing orders for patients on clinical trials. None had written an independent research protocol. Six had written and presented unusual case reports and three of these were presented at national meetings.
They commented that clinical research is time consuming, needs a lot of extra effort outside of patient care, and requires additional support staff. They have also heard that the IRB process can be prohibitory. They know this from talking to faculty. So, not surprisingly, it seems that clinically oriented training programs like ours are focused on clinical training, even when there are faculty on site who are committed to patient‐oriented research. There are limited funds and time to develop an infrastructure that allows the trainees to conduct pilot projects or learn about the clinical research process.
Dr. Weiner, in a previous commentary [Reference] spoke of an industrial academic partnership, and particularly for patient‐oriented research, this seems the most feasible approach. This could support the goals of both the academic researcher and the needs of industry to develop new medications and devices. When industry goes where the research infrastructure already exists, this limits exposure of new generations of trainees to patient oriented research. Sadly, this reinforces research becoming a distant option.
What is to be gained from supporting clinically oriented institutions for patient oriented research? Much information can be derived from this environment, for example studies of drug toxicities, additional mechanisms of action, and additional uses of these agents. In addition, this can contribute to the new generation of researchers that needs to be developed. Given the enthusiasm noted from my straw poll survey, mechanisms need to be developed and championed to enhance access to patient‐oriented research in the clinically oriented training environment. Otherwise, access to POR will continue to narrow.