By: Margaret A. Hamburg, M.D.
As my busy and productive trip to India drew to a close, I had the opportunity for one final meeting and one last memory with a group of some of the country’s most extraordinary women. The occasion was a Women’s Roundtable in Mumbai, organized by the Confederation of Indian Industry (CII). It brought together a diverse collection of female industry and academic leaders in India for a thought-provoking discussion and a wonderful chance to share perspectives with these accomplished women.
We covered a wide range of important and timely topics and could have gone on for much longer had time allowed. We discussed the many challenges that professional women often face in today’s workplace including efforts to achieve work-life balance and the importance of educating, motivating, mentoring and empowering women at every stage of both their professional and personal development. We also focused on a number of pressing issues in biomedical research, clinical trials and the regulatory framework for food and drugs.
What was most striking about this remarkable group of women is the commitment each has made not only to support one another in their diverse professional endeavors, but also to work to improve the lives of people living in India and around the world.
Two themes emerged during our discussion: the importance of biomedical research in India, specifically clinical trial design and enrollment; and the importance of quality and the role these prominent leaders in the pharmaceutical and food production sectors can play in communicating why quality matters.
The group expressed concern about the status of the clinical trial system in India. Many Indians have been wary of the way clinical trials have been conducted and how trial participants are chosen and informed. India has been in the midst of a significant re-examination of its clinical trial infrastructure and the legal, regulatory, ethical and scientific required for future research.
Certainly, we understand the importance of a vibrant, reliable and transparent clinical trials system. The information FDA receives and reviews from clinical trials conducted in the U.S. and abroad is an essential part of the agency’s decision-making for all new and existing drugs. Without it, we would not have important information such as how a drug works, whether it is reasonably safe for patients, and how the human body metabolizes the drug. Additionally, clinical trials may represent a vital mechanism to access an investigational drug for patients living with serious and life-threatening diseases.
Over the years, the FDA has worked closely with academia, industry and the advocacy community to improve transparency around the design and conduct of the clinical trials used to generate data for medical product review and approval. The agency has been working with the health care and research community to improve a clinical trial subject’s understanding of what it means to participate in a clinical trial, as well as the specifics of the trial in which they are considering enrollment.
Because the information we learn from clinical trials has the potential to benefit people living around the world – and the trials may be conducted in a wide range of countries – it is important that government officials, industry, the research community and patient organizations work together to ensure appropriate human subject protections, rigorous clinical trial design, and needed health care. We look forward to continuing our discussions with government, industry and academia on these important topics.
Quality was a recurring theme during my visit to India. I was pleased that the women who participated in the roundtable were as committed to quality as I am. As leaders in their industries and academic institutions, these women are uniquely positioned to help reinforce the message that quality matters and to educate the next generation of leaders in their respective industries and organizations about the importance of building quality into everything they do. And I was delighted that the group appreciated how smart regulation can help shape, support, and strengthen the product development and manufacturing processes that can help ensure continuous quality. In the words of moderator Swati Piramal, one of the highest ranking and most eminent leaders in Indian Pharma today, “good regulators make good companies.” And that combination can lead to better, safer and higher quality products – which benefits the health of people in both our nations and around the world.
Margaret A. Hamburg, M.D., is Commissioner of Food and Drugs