Would you rather?

How patient preference data make patient engagement real

Medical product developers, regulators and patients are starting to apply social science to life science, using techniques created to measure the preferences of individuals and groups to shape how medicines are designed, tested, regulated and used.

The integration of quantitative, testable methods for determining preferences into medical product development is being driven by the realization that reorienting the entire healthcare system to focus on the patients it serves is the best way to remove roadblocks to innovation.

Companies are adjusting to the reality that their customers are patients, not physicians or payers, and every step of the development continuum from target selection to trial design and product labeling can be improved by incorporating information about what patients want and need.

Regulators are realizing that physicians and government reviewers cannot serve as proxies for patients when assessing acceptable risk thresholds or determining the value of benefits, especially when the balance between risks and benefits is uncertain.

Well-conducted reproducible preference studies are a tool to make patient engagement, a stated goal of FDA and Congress, a reality. Through its patient-focused drug development meetings, FDA has already learned the value of patient perspectives.

"The patient-focused drug development meetings have created a cultural 'aha moment' at FDA," National Health Council CEO Marc Boutin told BioCentury. "Regulators, reviewers, academics and providers thought they understood the patient perspective, and in each one of the meetings they've held they've walked away saying that what they thought was most important to patients was wrong."

The NHC is a non-profit that advocates for patients with chronic diseases.

Patient advocates and caregivers are determined to overturn paternalistic doctor-knows-best medicine by taking the controls for as much of the healthcare journey as possible, and occupying the co-pilot's seat for the rest. They are demanding that their preferences about the trade-offs and risks inherent in medical decisions take precedence over the judgments of medical experts and government officials.

While preference research

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