care workforce. In a true learning health system, every patient with an incurable disease—and that is eventually most of us—would present an opportunity for active learning. Each practicing clinician and his or her consenting patients would be engaged in a massive tapestry of well-designed trials that would enable all of us to answer real-world questions in the most robust way possible: through randomization.
Some have argued that routine implementation of electronic health records (EHRs) and large-scale registries would suffice. While these tools would make observational research easier, they cannot by themselves enable rigorous scientific evaluation of the most important clinical questions, which can only be properly addressed with randomization.
We view the ideal clinical trials workforce as one in which all clinicians think scientifically. When confronted with a clinical problem for which definitive evidence is lacking, the clinician’s first thought should be, “What good trial would apply here? How can my patient and I be part of the solution?” Of course, effective deployment of EHRs with standardized data elements would allow randomized controlled trials (RCTs) to be done at a much lower cost by reducing or eliminating redundant data collection, but unless knowledge generation is embraced as a fundamental component of practice, the gap between existing evidence and practice needs will remain cavernous.
The ideal clinical trials workforce will be orders of magnitude larger than its present size, because it will include nearly all of the 90 percent of clinicians who currently are not part of the clinical trials enterprise. These clinicians will embrace research as a critical, indeed morally imperative, component of their work as medical professionals. They will work closely with professional clinical trialists who implement clinical research in the context of practice and will collaborate with them to prioritize, design, analyze, and interpret the trials that will be embedded into their practices. Of course, with a much larger proportion of American clinical practitioners and patients participating in the trials, there will also be an acute need for a larger workforce of professional trialists and clinical research professionals (see Table 1: Core Competencies in Clinical and Translational Research).
COMPETENCIES, FUNCTION, AND LOCUS OF NEEDED WORKFORCE
Realizing the vision of a significantly expanded clinical trials workforce will require major training efforts, both for new and veteran health care workers. A core set of competencies, including principles of responsible trials conduct and the fundamentals of study design, should be part of training programs for most of the clinical trials and clinical care