Series: Pragmatic trials and real world evidence: Paper 2. Setting, sites, and investigator selection

Journal of Clinical Epidemiology
Sally D WorsleyGetReal Work Package 3

Abstract

This second article in the series on pragmatic trials describes the challenges in selection of sites for pragmatic clinical trials and the impact on validity, precision, and generalizability of the results. The selection of sites is an important factor for the successful execution of a pragmatic trial and impacts the extent to which the results are applicable to future patients in clinical practice. The first step is to define usual care and understand the heterogeneity of sites, patient demographics, disease prevalence and country choice. Next, specific site characteristics are important to consider such as interest in the objectives of the trial, the level of research experience, availability of resources, and the expected number of eligible patients. It can be advisable to support the sites with implementing the trial-related activities and minimize the additional burden that the research imposes on routine clinical practice. Health care providers should be involved in an early phase of protocol development to generate engagement and ensure an appropriate selection of sites with patients who are representative of the future drug users.

Citations

May 16, 2017·Journal of Clinical Epidemiology·Paco M WelsingUNKNOWN Work Package 3 of the GetReal Consortium
May 16, 2017·Journal of Clinical Epidemiology·Elaine IrvingUNKNOWN GetReal Work Package 3
May 16, 2017·Journal of Clinical Epidemiology·Katrien Oude RengerinkUNKNOWN Work Package 3 of the GetReal consortium
Apr 6, 2018·Expert Review of Anti-infective Therapy·Matthew W McCarthy, Thomas J Walsh
Jan 14, 2020·Advances in Therapy·David A LeatherMike Thomas
Dec 7, 2019·Clinical and Translational Science·Charles A BrunetteJason L Vassy
Nov 13, 2018·Future Science OA·Fatih OzdenerAli Evrim Dogan
Jun 11, 2020·Journal of General Internal Medicine·Elena ByhoffUNKNOWN Society of General Internal Medicine
Apr 24, 2020·Journal of Clinical Epidemiology·Rafael Dal-RéStefan K James
Aug 30, 2020·Journal of the American Medical Directors Association·Kate H MagidCari Levy

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