In March 2019, the Health Ministry of India released new guidelines for clinical research. What is the state of pre-market and post-market safety for patients and drugs in India, six months after these new guidelines were announced? Dr. Srikanth Krishnamurthy, a consulting pulmonologist at Sri Bala Medical Centre and Hospital, discusses the pre-market clinical research safety perspective; and Dr. J. Vijay Venkatraman, Managing Director and CEO at Oviya MedSafe, contributes the perspective of post-market drug safety in India.
Where is real world data providing evidence that impacts therapeutic product development? “We're learning that, right now, the near-term uses are probably around label expansion and around providing information on new populations that's valuable but wasn't captured in randomized clinical trials or could not be captured in those trials,” explains Nicole Mahoney, Senior Director, Regulatory Policy, for Flatiron Health. “The real thing that you have to ask is: What decisions are you driving at? What is the regulatory question that you're trying to support with real world data?”
“We understand we need to educate people wherever they are about the power of personalized medicine,” says Edward Abrahams, President of the Personalized Medicine Coalition, which promotes the understanding and adoption of personalized medicine concepts. “We look forward to the day when patients ask, ‘Is this going to work for me?’ And we look forward to the day when providers can answer that question. It's a great question.”
FDA released its long-anticipated Communications with Payer Guidance in late 2018. “With rising healthcare costs, it's ever more important for payers to make the right informed decisions about access. From an industry perspective, we have to help them think about the value of the products,” suggests Sissi Pham, Founder and CEO of AESARA, Inc. and the AESARA Foundation. “This new guidance is actually a win for industry, but also a win for payers because now the channel of communication is open.”
Cell and gene therapy are raising new ethical questions in clinical research and practice. “It will probably be the case that breast cancer, which now affects both wealthy people and poor people, will increasingly be a disease of poor people because wealthy people were able to get rid of the mutation from their families,” suggests Robert Klitzman, Professor of Psychiatry at the Columbia University College of Physicians and Surgeons and Director of the University’s Bioethics Masters and Certificate Programs. “Is this the kind of world we want, where wealthy people can afford to have better genes?”
“Peoples’ data is valuable. We know that researchers want it. And people should be rewarded for sharing it,” suggests Dawn Barry, President and Co-founder of the public benefit corporation LunaPBC. In 2018, LunaPBC launched LunaDNA, a genomic medical research database owned by its community: LunaDNA members share in the platform’s value through ownership shares exchanged for their health data.
As Johnson & Johnson Chief Medical Officer, DIA 2019 Co-Chair Dr. Joanne Waldstreicher is responsible for the company’s collaborations in ethical science, technology, and R&D policies, including those related to clinical trial transparency and compassionate access. “When you ask people why they’re participating in a clinical trial, a big part of it is to benefit themselves, they might have a condition or a disease where they’re looking for a new treatment option,” she explains. “But a very large part of their motivation is to contribute to medical knowledge that will advance or help care for a future patient.”
The emerging digital healthcare landscape is already becoming quite visible around the world, especially in Japan. But what is the true impact of digital technology on clinical research, drug development, and healthcare? “Imaging data plus AI is one of the best combinations,” explains Dr. Kazuhiro Kanmuri, Founder and Chief Executive Officer of Inter-Professional, Inc. Dr. Kanmuri served on the Program Committee for the June 2019 DIA Japan Cutting Edge Series Workshop #1.
Conversations about disparate healthcare access often address therapies approved for market, but how can we ensure equity in the clinical R&D processes that generate these therapies? “There’s not a ‘one size fits all’ approach to overcoming all the barriers to recruiting diverse participants in clinical trials, and there may be specific considerations for various populations you’re intending to recruit,” explains CAPT Richardae Araojo, Associate Commissioner for Minority Health, and Director of the Office of Minority Health and Health Equity. “A plan to address inclusion should be developed early on; it should not be an afterthought, and it begins and ends with the patient in mind.” CAPT Araojo will help lead the Clinical Trial Diversity session at DIA 2019.
“Digitization is something that is happening to everything that we do. It’s being called the fourth industrial revolution,” explains Dr. Robert Califf, former FDA Commissioner and Vice Chancellor for Health Data Science at Duke Health. “And if we do it right, it will actually free up clinicians to spend more time directly with people and, when they become patients, with sick people, which is what we really want.”