Ethics in Clinical Trials and Access to Medicines

Biomedical research such as clinical trials are filled with many complex ethical issues, which includes quality of health care, post-trial access to medicines for research participants as well as general population, improper compensation mechanism in any incident of trial related injury etc. With the growing number of clinical trials in India, there have been many examples of clinical trials that have taken place with disregard to ethical aspects and participants’ rights. There exists a striking lack of transparency at the levels of planning, design and implementation of these trials. In the absence of adequate regulatory jurisdiction and systematic review of the industry, the reliability and validity of drug research in the country is jeopardized.

Sama considering health a fundamental human right, advocates for a rights based approach to health care for trial participants. Sama is involved in research on ethical issues in clinical trials, and access to medicines, capacity building initiatives to raise awareness on the issue, and policy level advocacy and engagement with ICMR (Indian Council of Medical Research), CDSCO (Central Drugs Standard Control Organisation), MoHFW (Ministry of Health and Family Welfare) etc.

”The invisible”: Participant’s experiences in clinical trials

Sarojini Nadimpally, Divya Bhagianadh | PICR | 2017 The paper discusses the perspectives of clinical trial participants about the various aspects of Clinical Trials (CTs) and is based on the primary research conducted by Sama in 2012-13. The paper describes the perspectives of participants on the relevant aspects of recruitment into… Continue reading

Study on ‘Compensation for Clinical Trial Injuries: A comparative analysis of seven countries’

Sama conducted an exploratory research focusing on compensation mechanisms in clinical trials. A systematic review of the compensation mechanism in seven countries including India was undertaken. Policy documents, legislations, published papers and studies, clinical trial registries, websites of the country regulatory bodies and case laws related to clinical trial injury… Continue reading

International Consultation on Bio Economies

Sama organised a two-day International Consultation Bio(Medical) Economies Today: Understanding Issues of Ethics, Markets and Labour on 29- 30 May, 2015 in Delhi. Major themes discussed in the consultation included the processes of co-constitution of economy and biomedical technologies, how women’s reproductive capacity and patients’ participation in clinical trials are giving rise… Continue reading