Careers for Clinician Investigators

For the purposes of this article, we define clinical research as that form of medical research that involves human beings as the direct subjects of the research at the individual or a population level. The research may involve the study of biological samples (eg, blood, genes, proteins, and tissue) as a means to understand the individual or the group, but the ultimate objective for the clinical investigator is a better understanding of the diagnosis and treatment of human diseases. Many researchers not trained as physicians perform clinical research; eg, many with PhD degrees work in health services research. The limited scope of this article necessitated that we focus on the physician investigator, henceforth referred to as clinician investigator.The process by which our knowledge of new therapies advances from bench observations to proof-of-concept bedside research and ultimately to widespread regular use in community practice is complex, often chaotic, and usually very inefficient, typically involving several decades of time between an important new basic finding and a useful clinical therapy. To help clarify the conceptual steps involved in generating evidence to inform clinical decision making and healthcare policy, we have used concepts borrowed from continuous quality improvement, particularly the cyclical nature of the process (the Figure).1 In this model, concepts and new therapies born in the laboratory provide translational investigators with new ideas, molecules, biologicals, devices, and diagnostics to test in early-phase clinical experiments. Promising ideas and technologies next move into larger clinical trials to adequately assess efficacy and safety in selected populations. Results from well-done clinical trials provide the evidence base for recommendations in practice guidelines and performance indicators used as quality measures.2 Observational research using practice- and disease-based registries helps define the degree to which clinical trial results have been assimilated into clinical care outside the …