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Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
Ladanie A, Schmitt AM, Speich B, Naudet F, Agarwal A, Pereira TV, Sclafani F, Herbrand AK, Briel M, Martin-Liberal J, Schmid T, Ewald H, Ioannidis JPA, Bucher HC, Kasenda B, Hemkens LG. Ladanie A, et al. Among authors: speich b. JAMA Netw Open. 2020 Nov 2;3(11):e2024406. doi: 10.1001/jamanetworkopen.2020.24406. JAMA Netw Open. 2020. PMID: 33170262 Free PMC article.
Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data.
Speich B, von Niederhäusern B, Schur N, Hemkens LG, Fürst T, Bhatnagar N, Alturki R, Agarwal A, Kasenda B, Pauli-Magnus C, Schwenkglenks M, Briel M; MAking Randomized Trials Affordable (MARTA) Group. Speich B, et al. J Clin Epidemiol. 2018 Apr;96:1-11. doi: 10.1016/j.jclinepi.2017.12.018. Epub 2017 Dec 27. J Clin Epidemiol. 2018. PMID: 29288136 Review.
Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list.
Speich B, von Niederhäusern B, Blum CA, Keiser J, Schur N, Fürst T, Kasenda B, Christ-Crain M, Hemkens LG, Pauli-Magnus C, Schwenkglenks M, Briel M; MAking Randomized Trials Affordable (MARTA) Group. Speich B, et al. J Clin Epidemiol. 2018 Apr;96:73-83. doi: 10.1016/j.jclinepi.2017.12.022. Epub 2017 Dec 30. J Clin Epidemiol. 2018. PMID: 29292203
The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs.
Ladanie A, Speich B, Naudet F, Agarwal A, Pereira TV, Sclafani F, Martin-Liberal J, Schmid T, Ewald H, Ioannidis JPA, Bucher HC, Kasenda B, Hemkens LG. Ladanie A, et al. Among authors: speich b. Trials. 2018 Sep 19;19(1):505. doi: 10.1186/s13063-018-2877-z. Trials. 2018. PMID: 30231912 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. PLoS One. 2019 Jan 11;14(1):e0210669. doi: 10.1371/journal.pone.0210669. eCollection 2019. PLoS One. 2019. PMID: 30633776 Free PMC article.
Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial).
Speich B, Bausch K, Roth JA, Hemkens LG, Ewald H, Vogt DR, Bruni N, Deuster S, Seifert HH, Widmer AF. Speich B, et al. Trials. 2019 Feb 19;20(1):142. doi: 10.1186/s13063-019-3237-3. Trials. 2019. PMID: 30782183 Free PMC article.
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