DIA: Driving Insights to Action

Participatory Medicine Changing Information Exchange

“Patient engagement is a subset of participatory medicine. Participatory medicine is about partnership between the patient and the clinical or scientific expert,” explains “ePatient Dave” deBronkart. “The whole purpose, the context, for this entire initiative is not to have physicians feel threatened, but to help healthcare achieve its potential with the patient contributing what they're able to.” Author of Let Patients Help: A Patient Engagement Handbook, Dave is a cancer survivor, patient advocate, and activist working to revolutionize the relationship between patients and healthcare providers.

New Ethics and Consent Guidelines Pillars for Safety in India

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.

Real World Data Expanding into Label Expansion

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?”