Publication rate and characteristics of cancer clinical trials in India

• Published in: Journal of cancer policy Vol. 26; p. 100248
• Main Authors: Thomas, Vinay Mathew, John, Vineeth Mathew, Alexander, Swetha Ann, Roy, Arya Mariam, Mathew, Aju
• Format: Journal Article
• Language: English
• Published: Elsevier Ltd 01.12.2020
• Subjects: Cancer clinical trials; Clinical trials registry; Clinical trials registry-India; Non-publication; Publication bias; Publication rate; Publication bias; Clinical trials registry; Non-publication; Cancer clinical trials; Clinical trials registry-India; Publication rate
• ISSN: 2213-5383; 2213-5383
• DOI: 10.1016/j.jcpo.2020.100248

•Non-publication of clinical trials leads to publication bias.•First study that looks at the publication rate of cancer clinical trials in CTRI.•Close to half of cancer clinical trials registered in CTRI remain unpublished.•Trials funded by international pharmaceuticals are more likely to be published.•Trials conducted at a multinational level are more likely to be published. Non-publication of clinical trials gives rise to publication bias which distorts data available in medical literature. Prior research indicates that a large number of clinical trials remain unpublished. We conducted a study to determine the publication rate of clinical trials related to cancer which were registered in the Clinical Trials Registry-India (CTRI), the clinical trials registry of India. We performed a cross-sectional analysis of CTRI to determine publication rates. We searched CTRI for completed interventional clinical trials related to cancer. A comprehensive search for publications of the registered trials was performed by three different investigators. We considered a trial to be published if the study or any outcome data pertaining to the study was accepted for publication in a peer-reviewed journal. 73 of the 133 trials (54.9 %) included in our study were published. Randomized controlled trials were more likely to be published than non-randomized trials (61 % vs 34 %, p 0.007). Trials funded by international pharmaceutical companies were more likely to be published than the ones by Indian pharmaceutical companies (72 % vs 24 %, p <  0.00001). Trials conducted at a multinational level were more likely to be published than the ones conducted only in India (84 vs 37 %, p <  0.00001). Large number of cancer clinical trials remain unpublished. This could be due to reluctance on the part of the investigator to publish statistically non-significant results, and sometimes to protect intellectual property. There is much scope for improvement in the rates of trial publication and information dissemination.