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Better recognition for research participants: what society should learn from covid-19

BMJ 2023; 380 doi: https://doi.org/10.1136/bmj-2022-071178 (Published 17 January 2023) Cite this as: BMJ 2023;380:e071178

Rapid Response:

Research participants to be share holders in profit- life long reciprocation of research participants

Dear Editor

Research participants in covid-19 clinical trials cannot be simply classified as participants only. Rather they should be called as real covid warriors because the trials were conducted with many flaws and minimal preclinical data on animal trials and possible long term side/adverse effects on human health. Societal respect normally considers participants’ needs from initial engagement until after the trial ends. Informed consent, transparent communication, meager travel concessions, compensation for research related injury, access to study findings and research products, purchase insurance policies are not actually part of reciprocation for participants, indeed a responsibility of all stake holders (regulatory authorities, funders, clinical sites, and monitoring committees) in clinical trials and the vested right of participants. During COVID pandemic, a huge number of pharmaceutical giants signed various Memorandum of understanding worth trillions of dollars for various pharmaceutical products like vaccines, oral products, etc. under clinical trials.

In our opinion, a structural framework is needed to keep a nominal percent of share in projections of profit of the pharmaceutical companies developing, producing/selling the products. This should be provided to all participants in any clinical trial leading to product development for profit organizations as a royalty. To be a share holder in a company’s profit will make the participants more responsible and positive towards clinical trial conduct and results. This will also significantly decrease the number of drop outs and fake reporting of adverse drug actions and increase the drug dosage compliance.

The COVID-19 crisis led to a flurry of clinical trials activity. The COVID-evidence database shows 2814 COVID-19 randomized trials registered as of February 16, 2021 with only 18% having a planned sample size > 500 and only 283 trial published results promptly. Similarly data from Clinical Trials.gov and the World Health Organization International Clinical Registry Platform showed registry of more than 500 RCTs in the first 100 days of the pandemic with most of trials to assess interventions for treating patients with COVID-19 and only 11% focused on interventions to prevent COVID-19 infection whereas none assessed social distancing or lock down measures. Most of trials were small and often investigated the same interventions (1). Hence the other way of better recognition to participants could be planning, permitting and executing those clinical trials which work on 360 degree angle of any disease. Planning trials with redundant data is never in favor of participants. Poorly designed, poorly reported (2) and duplication of many small studies (1) during the pandemic was a clear cut evidence of research waste. Repeating the similar type of work in different trials is misleading and disrespect to naive trial subject participants.

In COVID-19 unprecedented volume of research was quickly disseminated in the scientific literature and preprint servers, with over 200,000 items having been published by early December 2020, and the JAMA Network recorded 53% more submissions in the first quarter of 2020 compared with the year before (3). Another way of better recognition is not to use research participants only as publication material to incentivize the career progression of principle investigators.

1. Janiaud P, Hemkens LG, Ioannidis JP. Challenges and lessons learned from COVID-19 trials: should we be doing clinical trials differently?. Canadian Journal of Cardiology. 2021; 37(9):1353-64.
2. Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014; 383:267–276.
3. Kwon D. How swamped preprint servers are blocking bad coronavirus research. Nature. 2020; 581:130–131.

Competing interests: No competing interests

25 January 2023
Parveen Bansal
Joint Director
Dr.Renu Bansal, Dr.Cherry Bansal, Dr.Vikas Gupta
University Center of Excellence in Research, Academic Block, Baba Farid University of Health Sciences, Faridkot, Punjab, India.