Investigation of the conduct of clinical trials in India, focusing on three trials conducted in India for drugs seeking approval in the European Union.
This research project was undertaken with the support of WEMOS, a Dutch campaign organization, which works for equity and justice in international health. The study involved the use of qualitative research methods and secondary data review.
It covered the background and context of clinical trials in India, an analytical understanding of the international scenario of clinical research, findings of the investigation of three controversial trials for drugs to be used in breast cancer (lapatinib), acute mania (resperidone) and schizophrenia (quetiepine). These drugs were selected for study as research on them involved vulnerable participants (those who were terminally ill or had compromised judgment). The main findings of the study indicated that there was exploitation of economic vulnerability of trial participants, who could not afford treatment alternatives. Participating in clinical trials for majority was the only hope to survival due to the appalling lack of access to basic healthcare services. Participation was influenced by incentives to providers and a patient-provider relationship. In placebo controlled trials, seriously ill patients were deprived of effective and available drugs that are “usual care even in government facilities in India”, which is against the international ethical guidelines for research. There was no transperancy and lack of accountability of the companies involved in the research. Most did not provide sufficient documentation and did not reveal full information. It was also seen that the existing regulatory apparatus, which included the ethics committees, the drug controller general of India were not successful in preventing trials with questionable ethical standards and which did not hold out any benefit to the Indian public.Ethical concerns in clinical trials in India: An Investigation
Informed Consent in research on reproductive health with adolescents
This was a qualitative study to understand what adolescents who participate in surveys of reproductive health understand about informed consent, their perceptions about their rights as participants and their views about the ideal way to seek consent from them as participants.
The study is based on focus group interviews and in-depth interviews with boys and girls aged 15-19 years, who were selected for interview in an evaluation study of a reproductive health programme in Ranchi and Hazaribagh districts of Jharkhand.
The first set of group discussions were conducted with the objective of understanding the participants perception about the research study, relevance to their reproductive health, their views about the investigators involved in the study and their opinion about the ideal strategy for involving adolescents in such a study and obtaining free and informed consent. The latter (in-depth) interviews were conducted with a view to understanding the individual’s comprehension of the objective of the study, their rights as participants and the process by which they decided to participate or not participate in the study.
Developing short-term indicators for life-skills programmes for adolescents
The objective in this study was to understand how trainers in life-skills programmes perceive the process of change among their trainees as a consequence of participating in a life-skills programme. Likewise, this study aims to understand how this process of change is reflected in the thinking and life experiences of adolescents and young adults who have been participants of a life-skills programme. This study is ongoing. Fieldwork has been completed and the report is being prepared.
Focus group discussions had been conducted previously with life-trainers in four organisations Institute of Health Management, Pachod, Maharashtra, Ritinjali, Jhalawar, Rajasthan, Sahyog and Akanksha, Mumbai. This year, in-depth interviews were conducted with 36 young people (nine from each organisation’s alumni), including 27 girls and 9 boys. The ages of the girls ranged from 15 to 22 years, the ages of the boys between 17 to 22 years.
The questions asked covered experiences of schooling, education, family life including relationships with parents, siblings and others, friendships, views about getting married, love relationships, marriage, career ambitions, actions taken to fulfil those ambitions, actual work experiences, views about gender and gender-based violence. In addition, there were asked to speak about their experiences of the life-skills programmes, what they had appreciated about them and how they had applied those skills.