To include your compound in the COVID-19 Resource Center, submit it here.

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

Read the full 2089 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE