Abstract 1608P
Background
Timely dissemination of clinical trials helps physicians provide the best possible care for patients. Non-publication of clinical trials gives rise to publication bias which distorts data available in medical literature and violates an ethical obligation to study participants. Prior research indicates that a large number of global clinical trials remain unpublished. The Clinical Trials Registry-India (CTRI) is the clinical trials registry of India. We conducted a study to determine the rate of publication of clinical trials related to cancer which were registered in CTRI and conducted in India.
Methods
We performed a cross-sectional analysis of the CTRI to determine publication rates. We searched the 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. Conference proceedings were excluded from the analysis.
Results
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).
Conclusions
Our study reveals that a large number of cancer clinical trials remain unpublished.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. This study reveals there is much scope for improvement in the rates of trial publication and information dissemination.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.