Publication rate and characteristics of cancer clinical trials in India

Abstract

BackgroundNon-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 Prior research indicates that a large number of clinical trials remain unpublished.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. MethodsWe 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. Results73 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). ConclusionLarge number of cancer clinical trials remain unpublished.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.