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ACCP Report

From the Desk of an ACCP PBRN Community Advisory Panel Member: Practical Clinical Trials: The Pragmatic vs. Explanatory Debate

Written by Alan J. Zillich, Pharm.D.
Member, ACCP PBRN Community Advisory Panel


PBRN

Traditionally, clinical trials are developed and conducted to show the efficacy of a medication or device, and they often test a hypothesis in a well-defined, homogeneous population or clinical setting with limited outcomes data. Findings from these types of explanatory studies lead to significant evidence gaps to answer clinically and policy-relevant questions. Pragmatic (or practical) clinical trials are designed with the goal of generating data sufficient to make clinical decisions.1 In contrast to explanatory studies, pragmatic trials compare clinically relevant interventions, recruit a heterogeneous study population from a variety of practice settings, and collect a range of health outcomes data, including quality of life and costs. Tools are available to help investigators design studies that balance the pragmatic and explanatory components.2,3

Naturally, your ability as a scientist to conduct these studies requires access to patients, providers, and health care facilities. Practice-based research networks (PBRNs), particularly the ACCP PBRN, can provide the necessary access to successfully conduct a practical clinical trial. Fortunately, public and private funding for practical clinical trials is expanding. The National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), and the Veterans Affairs (VA) have funded and will continue to fund these trials. If you are developing a proposal, consider collaborating with the ACCP PBRN to conduct your practical trial of clinical pharmacy. Members of the ACCP PBRN invites all investigators (both funded and those seeking funding) to work with them on these studies.

References:

  1. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003;290:1624-32.
  2. Zwarenstein M, Treweek S, Gagnier J, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:2390.
  3. Thorpe KE, Zwarenstein M, Oxman AD, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 2009;62:464-75.