Patient Engagement Leadership Series: Applying The Voice Of The Patient

In Making Patient Engagement Work, my colleague, Jeff Terkowitz, discussed a 2015 survey of pharmaceutical companies in which 76% had started or were thinking of starting a patient advocacy program but less than 20% actually had a program with staff and 39% had budgeted less than $50,000.1

Companies that have created a position with the express purpose of patient engagement are seeing significant positive change in their cultures.

“The culture at TESARO has always emphasized putting patients at the center of everything we do.  However, the formalization of a position whose sole purpose is to keep the patient’s perspective front and center has served as a frequent reminder of this company value,” said Beth Zaharoff, Director of Patient Focused Clinical Trial Engagement at TESARO.

By having someone who formally prioritizes the patient voice present at meetings across multiple disciplines, “a wide swath of the company is regularly reminded of the importance of keeping our science robust while at the same time keeping it relevant to patients and as burden-free as possible,” Zaharoff said.  “One big difference that I’ve seen in our efforts to bring the patient voice into the development of our clinical trials is that the study teams now ask early on, ‘How soon can we get patient/advocacy input into the protocol?’”

Beyond culture, patient engagement could affect the bottom line.  An evaluation by the Office of the Assistant Secretary for Planning and Evaluation at the US Department of Health and Human Services (HHS) reported that 9% of amendments are caused by difficulties in recruiting study participants and 11.3% by protocol design flaws.2 Patient engagement might reduce the need for these costly amendments.

“The pharmaceutical industry employs a lot of very smart scientists who spend inordinate amounts of time developing protocols to answer complicated scientific questions…in the vast majority of cases, those scientists have never experienced the diseases they are writing protocols to study,” Zaharoff said.  “It is important then (both as a matter of practicality and dollars and cents) to ask for input from those who know if what is being asked of study participants is reasonable and can be accomplished.”

Zaharoff begins the process of patient engagement in clinical trials at TESARO by attending meetings when a new clinical trial protocol is first discussed.  She then reaches out to patient advocacy organizations supporting patients who have the disease that the medication in development is targeting.

“We explain that we would like their input/guidance and that of their constituents. We have criteria for the qualities we think a good reviewer should have which helps the organization to determine whom to reach out to for volunteers.  We developed guidelines for reviewers, have a mechanism for questions to be answered rapidly, and most importantly, we follow-up to let the reviewers know what has been changed as a result of their input,” she said.

This final step – letting the people who have helped know how their input has impacted the process – is critical for building trust.

“Being patient centric is simply listening to and applying the voice of the patient,” Zaharoff said. “Quite simply, it’s the right thing to do!”

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Inspire offers a trusted community to patients and caregivers.  Our goal with this blog, this website and our content is to provide the life science industry access to the true, authentic patient voice.  In so doing, we support faithful operationalization of patient-centricity.  Take a look at our case studies, eBooks and news outlet coverage.