MAKING PRAGMATIC TRIALS WORK
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1 MAKING PRAGMATIC TRIALS WORK iden6fica6on of opera6onal challenges & development of a decision support tool for pragma6c trial design WP3 Iris Goetz, Mira Zuidgeest November 24, 2016
2 Pragma6c trials on the rise Number of PubMed hits with pragma6c and trial in 6tle Term Pragma6c trial introduced Schwartz&Lellouch Journal of Chronic Diseases Extension consort statement Zwarenstein BMJ PRECIS tool Thorpe JCE Update to PRECIS-2 tool Loudon BMJ 2015
3 Pragma6c trials as a solu6on for RWE need Randomiza0on = prognos6c comparability between pa6ent groups Explanatory trial Pragma6c trial Observa6onal study Real World Evidence = How does treatment strategy A compare to treatment strategy B (ojen usual care) in daily clinical prac6ce?
4 What are pragma6c trials? explanatory con0nuum pragma0c Can treatment work? è EFFICACY Hypothesis tes6ng : Assess cause effect of drug Minimize varia6on: Rigid protocol, ideal circumstances - Selec6ve inclusion of par6cipants & sites WHAT? WHY? HOW? WHO? Does treatment work? èeffectiveness Generalisable to real world popula0on Compare treatment strategies : Guide prescribing in daily prac6ce Maximise generalizability Protocol reflec6ng usual care In rela0on to real - Broad world inclusion alterna0ves of par6cipants & sites - Compare drugs or against placebo - Outcomes research relevant - Data collec6on & monitoring > usual prac6ce METHOD? - Compare usual care treatment strategies Important to decision/ - Outcomes policy clinically makers relevant & - Data collec6on pa0ents & monitoring = usual prac6ce
5 Pragma6c trial example
6 Pragma6c trial example Design choices Opera6onal challenges Nawar 2013; New 2014
7 Pragma6c trials J opportunity to generate RWE in early stage of drug development L limited experience & unan6cipated opera6onal challenges WP3 Iden6fy opera6onal challenges Analyse impact on generalizability, validity, precision, stakeholder & ethical acceptability, resource use Iden6fy and propose solu6ons Overview paper series Develop decision support tool for pragma6c trial design PragMagic
8 PRAGMAGIC a decision support tool for pragma6c trial design
9 Forces at work Retropro & elung Van Staa 2014 TRIAL DESIGN ELEMENTS Choice 59% of sites: of sites expressed GENERAL PRACTICES interest in trial par6cipa6on OPERATIONAL CHALLENGES 4% training requirements & data collec6on à change of sites in usual actually prac6ce recruited & low/selec6ve pa6ents par6cipa6on generalizability GENERALIZABILITY, & feasibility VALIDITY, PRECISION generalisability STAKEHOLDER generalisability & ETHICAL ACCEPTABILITY par6cipa6ng GPs differed from feasibility those not RESOURCES par6cipa6ng elung trial did not recruit sufficient N of Programme (FP7/ ) and pa6ents EFPIA companies in kind contribu6on.
10 03Brussel-GetReal-Pragmagic-klikmodel.mov
11 The goal of PragMagic What PragMagic is NOT NOT a decision-making tool; NOT a checklist to assure (regulatory/ethical) compliance; NOT a quality check/verdict on study design.
12 Watch this space: first version of tool available early 2017 Run through a touch-and-feel version of PragMagic 12:00h-13:15h this ajernoon! agreement no [115303], resources of which are composed of financial contribu6on from the European Union s Seventh Framework
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