Recruitment of Research Participants
Increasing the volume and biomedical impact of clinical trials is a key element of our overall CTSA strategy. Trials that evaluate disease mechanisms, and test new therapeutic approaches are essential links in the chain that connects scientific discovery to improved human health. In decades past, clinical trial enrollment was largely diagnosis based (diabetes, COPD, asthma, arthritis, etc.). More recently, increased understanding of clinical and molecular phenotypes of disease, driven in part by increasingly specific therapeutic agents (including biologicals), has demanded a more sophisticated approach to clinical trials. For example, cancer trials are now enrolled virtually exclusively by molecular or biochemical tumor markers. Respiratory trials are enrolled by selected characteristics of airway inflammation. Rheumatology trials require presence or absence of specific immunologic markers. An important implication of this increasing clinical trial sophistication is that a decreasing proportion of patients with a given ‘disease’ will be eligible for entry into any given trial, and consequently, an increasingly large patient pool must be available to produce an acceptable number of patients with a specific sub-phenotype. Prior approaches using unsophisticated diagnosis-based recruitment will no longer suffice. Accordingly, we employ a research subject recruitment strategy based on a platform of Cohort Development Experts (CDE), that create standard testing panels for evaluation of specific disease entities. This approach is modeled after the US Severe Asthma Research Program (SARP) of which one of our CDE investigators was a founding member. Using this approach, the SARP recruited a cadre of patients with Severe Asthma, with relevant controls, and characterized them in consensus-based, standardized, and temporally consistent manner. This approach is applied more generally to establish research cohorts with sufficient phenotypic detail to facilitate enrollment into innovative clinical trials.