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Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study.
Lohner S, Gryaznov D, von Niederhäusern B, Speich B, Kasenda B, Ojeda-Ruiz E, Schandelmaier S, Mertz D, Odutayo A, Tomonaga Y, Amstutz A, Pauli-Magnus C, Gloy V, Bischoff K, Wollmann K, Rehner L, Meerpohl JJ, Nordmann A, Klatte K, Ghosh N, Heravi AT, Wong J, Chow N, Hong PJ, McCord K, Sricharoenchai S, Busse JW, Agarwal A, Saccilotto R, Schwenkglenks M, Moffa G, Hemkens LG, Hopewell S, von Elm E, Blümle A, Briel M. Lohner S, et al. Among authors: von elm e, von niederhausern b. J Clin Epidemiol. 2021 Nov;139:340-349. doi: 10.1016/j.jclinepi.2021.05.011. Epub 2021 May 23. J Clin Epidemiol. 2021. PMID: 34029678 Free article.
An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.
Stegert M, Kasenda B, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Briel M; DISCO study group. Stegert M, et al. Among authors: von elm e. J Clin Epidemiol. 2016 Jan;69:152-60. doi: 10.1016/j.jclinepi.2015.05.023. Epub 2015 Jun 4. J Clin Epidemiol. 2016. PMID: 26361993 Review.
Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis.
Speich B, Gryaznov D, Busse JW, Gloy VL, Lohner S, Klatte K, Taji Heravi A, Ghosh N, Lee H, Mansouri A, Marian IR, Saccilotto R, Nury E, Kasenda B, Ojeda-Ruiz E, Schandelmaier S, Tomonaga Y, Amstutz A, Pauli-Magnus C, Bischoff K, Wollmann K, Rehner L, Meerpohl JJ, Nordmann A, Wong J, Chow N, Hong PJ, Mc Cord-De Iaco K, Sricharoenchai S, Agarwal A, Schwenkglenks M, Hemkens LG, von Elm E, Copsey B, Griessbach AN, Schönenberger C, Mertz D, Blümle A, von Niederhäusern B, Hopewell S, Odutayo A, Briel M. Speich B, et al. Among authors: von elm e. PLoS Med. 2022 Apr 27;19(4):e1003980. doi: 10.1371/journal.pmed.1003980. eCollection 2022 Apr. PLoS Med. 2022. PMID: 35476675 Free PMC article.
Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE).
Gryaznov D, von Niederhäusern B, Speich B, Kasenda B, Ojeda-Ruiz E, Blümle A, Schandelmaier S, Mertz D, Odutayo A, Tomonaga Y, Amstutz A, Pauli-Magnus C, Gloy V, Lohner S, Bischoff K, Wollmann K, Rehner L, Meerpohl JJ, Nordmann A, Klatte K, Ghosh N, Taji Heravi A, Wong J, Chow N, Hong P, McCord-De Iaco KA, Sricharoenchai S, Busse JW, Agarwal A, Saccilotto R, Schwenkglenks M, Moffa G, Hemkens L, Hopewell S, Von Elm E, Briel M. Gryaznov D, et al. Among authors: von elm e. BMJ Open. 2022 May 24;12(5):e053417. doi: 10.1136/bmjopen-2021-053417. BMJ Open. 2022. PMID: 35613804 Free PMC article.
Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.
Kasenda B, von Elm E, You JJ, Blümle A, Tomonaga Y, Saccilotto R, Amstutz A, Bengough T, Meerpohl JJ, Stegert M, Olu KK, Tikkinen KA, Neumann I, Carrasco-Labra A, Faulhaber M, Mulla SM, Mertz D, Akl EA, Bassler D, Busse JW, Ferreira-González I, Lamontagne F, Nordmann A, 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. Kasenda B, et al. Among authors: von elm e. PLoS Med. 2016 Jun 28;13(6):e1002046. doi: 10.1371/journal.pmed.1002046. eCollection 2016 Jun. PLoS Med. 2016. PMID: 27352244 Free PMC article.
Resource use, costs, and approval times for planning and preparing a randomized clinical trial before and after the implementation of the new Swiss human research legislation.
Speich B, Schur N, Gryaznov D, von Niederhäusern B, Hemkens LG, Schandelmaier S, Amstutz A, Kasenda B, Pauli-Magnus C, Ojeda-Ruiz E, Tomonaga Y, McCord K, Nordmann A, von Elm E, Briel M, Schwenkglenks M; a collaboration of the MARTA (MAking Randomized Trials Affordable) and ASPIRE (Adherence to Standard Protocol Items: REcommendations for interventional trials) Study Groups. Speich B, et al. Among authors: von elm e, von niederhausern b. PLoS One. 2019 Jan 11;14(1):e0210669. doi: 10.1371/journal.pone.0210669. eCollection 2019. PLoS One. 2019. PMID: 30633776 Free PMC article.
172 results