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Advances in scientific discovery are converging with unparalleled policy and regulatory action for medical research. At FasterCures, we have surveyed the landscape and interviewed subject matter experts to come up with our recommendations of the top 10 issues to keep an eye on in 2016:
1. Patient engagement: Put a ring on it (with apologies to Beyoncé)
Patient engagement was the “hot date” of 2015, and it’s about time, right? Now, 2016 must be about turning it into a lasting commitment before the passion fades. Anecdotal evidence is building about the positive impact of patient input on R&D efficiency and effectiveness, but this needs to become a discipline that is scalable and actionable. Methods for collecting and applying patient perspective data must be created and consensus built around them. Skills and capacities need to be built in organizations, from industry to patient groups to regulators and, yes, even payers. Concerns about conflict-of-interest must be addressed. The U.S. Food and Drug Administration (FDA) is leading the way by offering guidance on incorporating patient preferences into clinical trial designs and using those data to inform approval decisions; its new Patient Engagement Advisory Committee will convene in 2016.
2. Value frameworks: The time has come to put patients in the picture
2015 saw the introduction of multiple frameworks for determining the value of new medical products, including those from American Society of Clinical OncologyInstitute for Clinical and Economic ReviewMemorial Sloan Kettering Cancer Center and National Comprehensive Cancer Network. These tools will continue to proliferate, with varying audiences and objectives. While all claim to have patients’ interests at heart, none have included patient participation and insight in any significant way. And all this at a time when patients are paying an increasing load for their health care. What are the critical elements of value from patients’ perspective? How can and should they be considered in reimbursement decisions? What’s the value proposition for payers in particular to engage with patient groups? Look for patients to get more engaged with these exercises in 2016 as they realize decisions are being made “about them without them.” It’s time.
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