Francisco E Vera-Badillo1, Marc Napoleone1, Monika K Krzyzanowska1, Shabbir M H Alibhai2, An-Wen Chan3, Alberto Ocana4, Bostjan Seruga5, Arnoud J Templeton6, Eitan Amir1, Ian F Tannock7. 1. Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Department of Medicine, University of Toronto, 610 University Ave, Toronto M5G 2M9, Canada. 2. Division of General Internal Medicine and Geriatrics, University Health Network, Department of Medicine, University of Toronto, 610 University Ave, Toronto M5G 2M9, Canada. 3. Women's College Hospital and Research Institute, Division of Dermatology, Department of Medicine, University of Toronto, 76 Grenville St, Toronto M5S 1B2, Canada. 4. Medical Oncology Department and Translational Research Unit, Albacete University Hospital, Calle Hermanos Falco, 37, Albacete 02006, Spain. 5. Sector of Medical Oncology, Institute of Oncology Ljubljana, University of Ljubljana, Zaloska cesta 2, Ljubljana 1000, Slovenia. 6. Department of Medical Oncology, Kantonsspital St Gallen, Rorschacher Str. 95, St. Gallen 9007, Switzerland. 7. Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Department of Medicine, University of Toronto, 610 University Ave, Toronto M5G 2M9, Canada. Electronic address: Ian.Tannock@uhn.ca.
Abstract
BACKGROUND: Bias in reporting efficacy and toxicity in clinical trials may impact treatment decisions. Here, we report quality of reporting of efficacy and of toxicity in articles describing randomised controlled trials (RCTs) of cancer therapy and the association between biased reporting and study results, funding and financial relationships of the authors with the sponsor. MATERIALS AND METHODS: We reviewed articles published from July 2010 to December 2012 in six high-impact journals reporting RCTs of systemic treatment for cancer. Bias in reporting of the primary end-point and toxicity were assessed. Associations between biased reporting and study results, funding source and financial ties of the author with the funding source were evaluated using logistic regression. RESULTS: Two hundred articles were identified. Among 107 RCTs where there was no statistically significant difference in the primary end-point between the two arms, 50 (47%) reports used biased reporting in the abstract of the paper to imply benefit of the experimental treatment. Toxicity was not reported in the abstract in 18.5% of the studies and this was associated with a positive primary end-point. Source of funding and financial ties were not associated with biased reporting. CONCLUSIONS: Bias in reporting of efficacy outcomes is common for studies with a negative primary end-point and can lead to off-label misuse of experimental therapies, if they are approved for other indications. Toxicity is under-reported, especially for studies with a positive primary end-point, leading to a biased view of the safety of new treatments.
BACKGROUND: Bias in reporting efficacy and toxicity in clinical trials may impact treatment decisions. Here, we report quality of reporting of efficacy and of toxicity in articles describing randomised controlled trials (RCTs) of cancer therapy and the association between biased reporting and study results, funding and financial relationships of the authors with the sponsor. MATERIALS AND METHODS: We reviewed articles published from July 2010 to December 2012 in six high-impact journals reporting RCTs of systemic treatment for cancer. Bias in reporting of the primary end-point and toxicity were assessed. Associations between biased reporting and study results, funding source and financial ties of the author with the funding source were evaluated using logistic regression. RESULTS: Two hundred articles were identified. Among 107 RCTs where there was no statistically significant difference in the primary end-point between the two arms, 50 (47%) reports used biased reporting in the abstract of the paper to imply benefit of the experimental treatment. Toxicity was not reported in the abstract in 18.5% of the studies and this was associated with a positive primary end-point. Source of funding and financial ties were not associated with biased reporting. CONCLUSIONS: Bias in reporting of efficacy outcomes is common for studies with a negative primary end-point and can lead to off-label misuse of experimental therapies, if they are approved for other indications. Toxicity is under-reported, especially for studies with a positive primary end-point, leading to a biased view of the safety of new treatments.
Authors: Fabio Y Moraes; Lucas C Mendez; Neil K Taunk; Srinivas Raman; John H Suh; Luis Souhami; Ben Slotman; Eduardo Weltman; Daniel E Spratt; Alejandro Berlin; Gustavo N Marta Journal: J Neurooncol Date: 2017-11-21 Impact factor: 4.130
Authors: Eliane Rohner; Michael Grabik; Thomy Tonia; Peter Jüni; Frank Pétavy; Francesco Pignatti; Julia Bohlius Journal: PLoS One Date: 2017-12-11 Impact factor: 3.240
Authors: Huseyin Naci; Courtney Davis; Jelena Savović; Julian P T Higgins; Jonathan A C Sterne; Bishal Gyawali; Xochitl Romo-Sandoval; Nicola Handley; Christopher M Booth Journal: BMJ Date: 2019-09-18
Authors: Angela MacCarthy; Shona Kirtley; Jennifer A de Beyer; Douglas G Altman; Iveta Simera Journal: Br J Cancer Date: 2018-02-22 Impact factor: 7.640