3:25 PM
Nov 14, 2017
 |  BioCentury  |  Regulation

Rules of engagement

How an NHC framework could allay concerns about regulatory pitfalls of patient engagement

An upcoming publication from the National Health Council on good practices for sponsor-patient interactions could help companies overcome fears that their outreach could be construed as promotional. Several executives told BioCentury that having guardrails established by a trusted third party could get more companies to engage with patients during drug development.

In the future, companies also want principles on how to engage patients most effectively.

NHC released a summary of its work, titled “Sponsor-Patient Interactions During Drug Development: Good Practice Insights on Patient Engagement,” on Nov. 2. The summary is based on discussions at a June 15 meeting co-hosted with Genetic Alliance Inc. and the Food and Drug Law Institute, with participation from patient advocacy groups, life science companies, government agencies including NIH, academic institutions, non-profit organizations and professional and industry trade associations.

It describes general principles that sponsors can adopt to avoid engaging with patients in a way that is or could be misinterpreted as promotional. The full framework will be submitted for publication this month.

The principles start with establishing and articulating up front a clear objective for the engagement. NHC SVP of Strategic Initiatives Eleanor Perfetto said this is one of the most important elements in a good sponsor-patient interaction.

“If your reason is sound, it’s easier for the rest of the things to fall into place.”

Eleanor Perfetto, National Health Council

“If your reason is sound, it’s easier for the rest of the things to fall into place. But if the rationale is unclear, then the rest of it can very well be all over the place,” she said.

According to the summary, goals for the partnership should be mutually agreed upon. And sponsors should document in writing how the parties interacted, how participants were chosen and the forum where the parties engaged. Both sponsors and patients should benefit from the interaction in ways that are clear from the outset.

The principles say sponsors should engage patients in long-term partnerships throughout a product’s life cycle, starting before a company has selected a product candidate and continuing through commercialization.

In contrast, the document says, it would be poor practice for a sponsor only to make a product-specific outreach close to the time of approval, without an established history of outreach to patients or a clearly stated purpose for the interaction.

Sponsor-patient partners also should decide up front how to select participants from each organization, including what sponsor employee roles or patient types are needed. They should ensure that the resulting participant mix is balanced so that patient participants are...

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