Modernizing adverse events analysis in oncology clinical trials using alternative approaches: rationale and design of the MOTIVATE trial-Reference-Cited by-同舟云学术

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Modernizing adverse events analysis in oncology clinical trials using alternative approaches: rationale and design of the MOTIVATE trial

Published:2020-05-07 Issue:6 Volume:38 Page:1879-1887
ISSN:0167-6997
Container-title:Investigational New Drugs
language:en
Short-container-title:Invest New Drugs

Author:

Cabarrou Bastien,Gomez-Roca Carlos,Viala Marie,Rabeau Audrey,Paulon Rodolphe,Loirat Delphine,Munsch Nadia,Delord Jean-Pierre,Filleron Thomas

Funder

Bristol-Myers Squibb Foundation

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Oncology

Link

https://link.springer.com/content/pdf/10.1007/s10637-020-00938-x.pdf

Reference41 articles.

1. Ioannidis JPA, Evans SJW, Gøtzsche PC, O’Neill RT, Altman DG, Schulz K, Moher D (2004) CONSORT group, better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 141:781–788. https://doi.org/10.7326/0003-4819-141-10-200411160-00009

2. Péron J, Maillet D, Gan HK, Chen EX, You B (2013) Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review. J Clin Oncol Off J Am Soc Clin Oncol 31:3957–3963. https://doi.org/10.1200/JCO.2013.49.3981

3. Sivendran S, Latif A, McBride RB, Stensland KD, Wisnivesky J, Haines L, Oh WK, Galsky MD (2014) Adverse event reporting in cancer clinical trial publications. J Clin Oncol Off J Am Soc Clin Oncol 32:83–89. https://doi.org/10.1200/JCO.2013.52.2219

4. Basch E (2010) The missing voice of patients in drug-safety reporting. N Engl J Med 362:865–869. https://doi.org/10.1056/NEJMp0911494

5. E. Basch, B.B. Reeve, S.A. Mitchell, S.B. Clauser, L.M. Minasian, A.C. Dueck, T.R. Mendoza, J. Hay, T.M. Atkinson, A.P. Abernethy, D.W. Bruner, C.S. Cleeland, J.A. Sloan, R. Chilukuri, P. Baumgartner, A. Denicoff, D. St Germain, A.M. O’Mara, A. Chen, J. Kelaghan, A.V. Bennett, L. Sit, L. Rogak, A. Barz, D.B. Paul, D. Schrag, Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 106 (2014). https://doi.org/10.1093/jnci/dju244

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