Various reports have hailed India as an upcoming ‘hub of clinical research’. What is the reality?
| Dr Tal Burt |
India is a ‘superpower’ in the making that would want indigenous clinical research capabilities to support an independent healthcare environment. It has many ‘pros’ relevant to clinical research such as English-speaking healthcare professionals, expert clinicians, access to large patient populations in diseases of public health interest, competitive operational costs, and internationally harmonised regulations. However, a few ‘cons’ emerged: less-than-optimal enforcement of regulations led to doubts over methodological and ethical rigor of clinical trials conducted in India. The future of clinical research in India depends on the management of the balance between these ‘pros’ and ‘cons’. It is in the hands of the Indian regulators, clinical research professionals and public stakeholders to guide the sector to a successful future. Instead of ‘reality’ I will offer my belief: it will happen.
What has been the impact on the practice of clinical research in India?
The media has reported instances of poor conduct and poor enforcement of clinical trial regulations. Activists protested. Alarmed government initiated a review and revision of the regulatory environment which further slowed regulatory approval timelines, scaring away sponsors. 2011 has seen a drop in the number of new clinical trials in India to levels of 2007 (according to the Boston Consulting Group [BCG] analysis of the data). This is an unprecedented trend in the developing world where growth in the clinical research sector has continued even in the face of global recession.
| PARTAKE Steering Committee |
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The PARTAKE Steering Committee are representative of the stakeholders involved 1. Dr Nandini Kumar, former Deputy Director General, Co-investigator NIH Project on Bioethics National Institute of Epidemiology, Chennai, India |
What is the objective of the PARTAKE – (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)—programme?
This clinical research educational programme has the following goal and objectives:
Goal is to enhance public awareness and partnership in clinical research and the objectives are as follows:
A. A public whose view of clinical research is evidence-based and reflecting an understanding of:
1. Clinical research effectiveness, usefulness and beneficence
2. Clinical research risks
3. Clinical research process—including the required resources and timelines
4. Clinical research regulatory process, ethics and accountability
B. A public who is an active partner in the effort to advance therapeutics and enhance medical knowledge
C. A public who is a knowledgeable observer and valuable endorser, educated supporter and empowered participant in clinical research operations
What are the activities being planned?
The first step, already completed is development and administration of pilot PARTAKE survey to study public knowledge and perceptions of clinical research. The second step is to have a meeting of all stakeholders involved in clinical research in India (public, NGOs, patient advocacy, media, government, industry, academia, clinicians). The PARTAKE stakeholder meeting will take place July 14 2012 in Delhi. The PARTAKE Survey results will be presented so that a balanced, informed stakeholder consensus will determine the next steps for the initiative.
What are the long term objectives of this initiative?
Practically, we will need to seek funding, to sustain our activities. The ultimate goal is: To promote awareness, knowledge, participation and partnership in clinical research so as to advance the promise of effective, safe, and ethical research to alleviate suffering from medical causes for the Indian people and the world at large.
Any other points you’d like to raise?
One of our main challenges is to engage the public at large, patient advocacy, NGOs in the initiative. Do help spread the word and our invitation to all stakeholders.