Learning Session 9: Clinical Trials and Learning Healthcare Systems Research

4/20/20

Presenter: Kate Deans, MD, MHSc, Nationwide Children's Hospital

Learning Objectives:

  1. Understand the definition of a clinical trial according to the NIH, and the implications of standardization. (https://grants.nih.gov/policy/clinical-trials/definition.htm)
  2. Define and discuss pragmatic clinical trials and their particular relevance to LHS research.
  3. Define and discuss the strengths and limitations of adaptive trial designs and their sustainability to LHS research. 

References:

    1. Marquis-Gravel G, Roe MT, Robertson HR, Harrington RA, Pencina MJ, Berdan LG, Hammill BG, Faulkner M, Muñoz D, Fonarow GC, Nallamothu BK, Fintel DJ, Ford DE, Zhou L, Daugherty SE, Nauman E, Kraschnewski J, Ahmad FS, Benziger CP, Haynes K, Merritt JG, Metkus T, Kripalani S, Gupta K, Shah RC, McClay JC, Re RN, Geary C, Lampert BC, Bradley SM, Jain SK, Seifein H, Whittle J, Roger VL, Effron MB, Alvarado G, Goldberg YH, VanWormer JL, Girotra S, Farrehi P, McTigue KM, Rothman R, Hernandez AF, Jones WS. Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial. JAMA Cardiol. 2020 Mar 18. doi: 10.1001/jamacardio.2020.0116.
    2. Pallmann, P., Bedding, A.W., Choodari-Oskooei, B. et al. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med 16, 29 (2018). https://doi.org/10.1186/s12916-018-1017-7
    3. Marsolo, Keith & Brown, Jeffrey & Hernandez, Adrian & Hammill, Bradley & Raman, Sudha & Syat, Beth & Platt, Richard & Curtis, Lesley. (2020). Considerations for Using Distributed Research Networks to Conduct Aspects of Randomized Trials. Contemporary Clinical Trials Communications. https://doi.org/10.1016/j.conctc.2019.100515

    Learning Session 9 Slide Deck