Assessment of Frequency and Reporting of Changes in Cancer Trial Design After Initiation of Patient Accrual

Author:

Shepshelovich Daniel12,Tibau Ariadna3,Molto Consolación3,Goldvaser Hadar14,Ocana Alberto56,Šeruga Bostjan7,Amir Eitan18

Affiliation:

1. Division of Medical Oncology & Hematology, Department of Medicine, Princess Margaret Cancer Centre, Toronto, Ontario, Canada

2. Department of Internal Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

3. Oncology Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain

4. Department of Oncology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

5. Research Unit, Translational Oncology Laboratory, Regional Center for Biomedical Research (CRIB), Albacete University Hospital, Albacete, Spain

6. Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Castilla–La Mancha University, Albacete, Spain

7. Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia

8. Department of Medicine, University of Toronto, Toronto, Ontario, Canada

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Reference6 articles.

1. From protocols to publications: a study in selective reporting of outcomes in randomized trials in oncology.;Raghav;J Clin Oncol,2015

2. Characteristics of interim publications of randomized clinical trials and comparison with final publications.;Woloshin;JAMA,2018

3. Comparison of primary endpoints between publications, registries, and protocols of phase III cancer clinical trials.;Liang;Oncotarget,2017

4. CONSORT statement, 6b: changes to outcomes. http://www.consort-statement.org/checklists/view/32--consort-2010/81-changes-to-outcomes. Accessed June 12, 2018.

5. US Food and Drug Administration. Hematology/oncology (cancer) approvals & safety notifications. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm. Updated October 16, 2018. Accessed October 28, 2018.

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