There is a continuing need for the development of scientifically sound, efficient, ethical, and safe methods for the assessment of medical interventions. The proposed conference will consider special statistical issues in the design, conduct, and analysis of “pragmatic” trials. This is an area of rapidly emerging interest, as we recognize that many important public health questions cannot be feasibly addressed using more traditional, resource-intensive approaches. Pragmatic trials are more likely to be conducted in the community than in academic health centers, may utilize electronic health records rather than active data collection via case report forms, and will require special considerations for design, conduct, and analysis. We expect the conference to promote the development of improved methods for pragmatic clinical trials that will benefit all stakeholders, including trial participants, patients, practicing clinicians, research leaders and funders, and payers.
The projected outputs from this project include an interactive conference on statistical issues in pragmatic clinical trials with presentations and panel discussion to contribute to the development of statistical methodology for the design, conduct and analysis of pragmatic clinical trials; and a peer reviewed publication of presentations as well as highlights from panel discussions to be published in Clinical Trials.
Project collaborators include the Perelman School of Medicine at the University of Pennsylvania; Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania; American Statistical Association; and Society for Clinical Trials.