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The mystery of India’s missing clinical trial results

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4835 (Published 18 December 2020) Cite this as: BMJ 2020;371:m4835
  1. Shreya Dasgupta, freelance journalist
  1. Bengaluru, India
  1. shreya.dg{at}gmail.com

India made the registration of clinical trials mandatory in 2009. But published results are only available for around a quarter of those registered between then and 2015, pointing to a lack of accountability and transparency. Shreya Dasgupta reports

Vivek Tomar, 38, is a staunch advocate of clinical trials in India. His wife Kusum, diagnosed with a rare type of lung cancer in 2012, benefited from one. When the first line of treatment stopped being effective, the Tomars tried to access new drugs being tested in clinical trials and were elated when Kusum was enrolled in a study testing a drug called ceritinib in India’s capital Delhi. Kusum died in 2019, but the experimental drugs gave her more years of life than doctors had initially predicted, Tomar says.

Yet, as a pharmaceutical regulatory professional who likes to keep informed about the latest medical developments in the field of lung cancer, Tomar struggles to find published results of trials that either Kusum or other patients within his advocacy groups were a part of. “If a paper isn’t published and results not shared, we won’t know what happens in the Indian setting, what the side effects are,” Tomar told The BMJ. “Not knowing results creates a lack of confidence in clinical trials.”

Tomar isn’t alone in his frustration. A recent study1 found that 45% of 133 cancer related clinical trials registered in the Clinical Trials Registry of India (CTRI) up to February 2016, and that had completed recruitment, hadn’t published their results as of June 2020. Such non-publication of results is both scientifically and ethically problematic, says Aju Mathew, from the University of Kentucky Markey Cancer Center in the US, and director of Kerala Cancer Care in Kochi, Kerala. Some patients enrol in trials hoping that their participation will help save …

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