印度之旅 - 生物医学研究与质量的重要性
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印度之旅 - 生物医学研究与质量的重要性
笔记 2014-02-22 FDA Voice Margaret A. Hamburg，医学博士 在忙碌而富有成效的印度之旅接近尾声之际，我有机会与这个国家最杰出的一些女性会面，留下一段共同的记忆。这是由印度工业联合会（CII）组织的孟买妇女圆桌会议。会议汇集了很多印度产业界和学术界的领袖，进行了引人深思的讨论，提供了一个与这些成功女性分享观点的绝好机会。 我们讨论的内容涵盖了一系列重要和正当其时的话题，如果时间允许，我们本可以谈得更久。我们讨论了职业女性在当今的工作中经常会遇到的很多挑战，包括努力实现工作和生活之间的平衡，以及在专业和个人发展的各个阶段对女性开展教育、激励、指导和赋予女性权力的重要性。我们还集中讨论了生物医学研究、临床试验、食品药品监管框架方面的一些紧迫问题。 这些杰出女性最为引人注目的，不仅仅在于支持各自专业领域奋进，还在于致力于提高印度人民和世界人民的生活质量的担当。 我们讨论的过程中产生了两大主题：印度生物医学研究的重要性，尤其是临床试验设计和受试人群招募；质量的重要性以及这些药品和食品生产部门的杰出领袖在传达质量所起的重要性过程中所发挥的作用。 与会者表达对印度临床试验体系现状的担忧。很多印度人对临床试验的进行方式以及如何选择和信息知情表现持谨慎态度。印度已经着手重新审视临床试验基础设施和未来开展研究法律、法规、伦理和科学要求。 当然，我们明白灵活、可靠、透明的临床试验体系的重要性。FDA接受和审查来自美国和国外的临床试验，这是对所有的新药和现有药品做出决策的至关重要的部分。如果没有这些，我们将不能获取重要信息，例如药物作用方式，药品对患者的安全性是否合理，以及人体如何代谢该药物。除此之外，对于针对患有严重的、致命疾病的患者的研究药物，临床试验可能意味着一种非常重要的获得研究用药品的机制。 多年以来，FDA与学术界、产业界和患者权益保护团体密切合作，提高为医药产品审评与审批提供数据的临床试验设计及实施的透明度。FDA一直与医疗保健和研究团体合作，提高临床试验受试者对于参加一项临床试验意味着什么，以及他们正在考虑是否入组的临床试验细节的认识。 由于我们从临床试验中了解到的数据可能对全世界人民有益，而且临床试验可能在很多国家进行，政府官员、产业界以及研究组织、患者组织通力合作，确保受试人员得到恰当保护，临床试验设计严谨以及必要的医疗保健措施非常重要。我们期待与政府、产业界以及学术组织继续探讨这些重要议题。 质量是我在这次印度之旅中反复出现的话题。很高兴参加圆桌会议的女性像我一样致力于质量问题。作为他们产业界和学术机构领袖，这些女性在帮助强化质量所发挥的作用的信息，以及在教育下一代相关领域和组织的带头人保证使质量成为所有事情的固有组成的重要性方面，有着得天独厚的优势。我很高兴，与会者充分肯定明智监管可有助于塑造、支持和加强产品开发和生产工艺过程，确保持续的高质量。用会议主持人Swati Piramal，今天印度药业名望最高，最杰出的领导者的话来说，“好的监管机构造就好公司。”这种强强组合将成就更好、更安全、质量更高的产品——这将益于我们两个国家以及全世界人民的健康。 翻译：识林-Kapok Visiting India: The Importance of Biomedical Research and Quality 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. |