Summary
This research program monitors the quality, fate and transparency of randomized clinical trial protocols approved by research ethics committees in Switzerland, Freiburg (Germany), Hamilton (Canada), and Oxford (UK). In close collaboration with involved stakeholders we investigate the prevalence of and underlying reasons for trial discontinuation, non-registration, and non-publication of clinical trials using mixed methods. Our aim is to identify lever points to improve trial conduct and results availability. 

Publications

• Briel M, Elger BS, von Elm E, Satalkar P. Insufficient recruitment and premature discontinuation of clinical trials in Switzerland: Qualitative study with trialists and other stakeholders. Swiss Med Weekly 2017;147:w14556
• Schmucker C, Blümle A, Schell LK, Schwarzer G, Oeller P, Cabrera L, von Elm E, Briel M, Meerpohl JJ on behalf of the OPEN consortium. Systematic review finds that study data not published in full text articles have unclear impact on meta-analyses results in medical research. PloS One 2017;12(4):e0176210
• Schandelmaier S, Tomonaga Y, Bassler D, Meerpohl JJ, von Elm E, You JJ, Blümle A, Lamontagne F, Saccilotto R, Amstutz A, Bengough T, Stegert M, Olu KK, Tikkinen KAO, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Sun X, Busse JW, Ferreira-González I, Nordmann A, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Vandvik, PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Guyatt GH, Bucher HC, Kasenda B, Briel M. Premature Discontinuation of Pediatric Randomized Controlled Trials: A Retrospective Cohort Study. Journal of Pediatrics 2017;184:209-214
• Alturki R, Schandelmaier S, Olu KK, von Niederhäusern  B, Agarwal A, Frei R, Bhatnagar N, von Elm E, Briel M. Premature trial discontinuation often not accurately reflected in registries: comparison of registry records with publications. J Clin Epidemiol 2017;81:56-63
• Briel M*, Olu KK*, von Elm E, Kasenda B, Alturki R, Agarwal A, Bhatnagar N, Schandelmaier S. A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable. J Clin Epidemiol 2016;80:8-15
• Kasenda B, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl JJ, Stegert M, Olu KK, Tikkinen KAO, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann AJ, Gloy V, Raatz H, Moja L, Ebrahim S, Schandelmaier S, Sun X, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens LG, Bucher HC, Guyatt GH, Briel M. Agreements on publication rights – An investigation of protocols and publications of randomized clinical trials. PLoS Med 2016;13(6):e1002046
• Schandelmaier S, von Elm E, You J, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl J, Stegert M, Olu KK, Tikkinen KAO, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla S, Mertz D, Akl EA, Sun X, Bassler D, Busse J, Ferreira-González I, Lamontagne F, Nordmann AJ, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Vandvik PO, Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens L, Bucher HC, Meade MM, Cook DJ, Kasenda B*, Briel M*. Premature discontinuation of randomized trials in critical and emergency care: A retrospective cohort study. Crit Care Med 2016;44(1):130-7
• Kasenda B, von Elm E, You J, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl J, Stegert M, Tikkinen KAO, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla S, Mertz D, Akl EA, Bassler D, Busse J, Ferreira-González I, Lamontagne F, Nordmann AJ, Gloy V, Raatz H, Moja L, Rosenthal R, Ebrahim S, Schandelmaier S, Sun X, Vandvik PO,  Johnston BC, Walter MA, Burnand B, Schwenkglenks M, Hemkens L, Bucher HC, Guyatt GH, Briel M. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA 2014;311(10):1045-1051

Basel research team
Dmitry Gryaznov, Benjamin Speich, Katherina Klatte, Benjamin Kasenda, Lars Hemkens, Christiane Pauli-Magnus, Matthias Briel