Dear Sponsor: The Patient Will See You Now
Tipping Point in Clinical Research

Roslyn Schneider
Pharmaceutical Physician
Former Head of Global Patient Affairs
Pfizer, Inc.

Richard Stephens
Former Chair, NCRI Consumer Forum
Joint Editor-in-Chief
Journal of Research Involvement and Engagement

Tony Hoos
Pharmaceutical Physician
Former Head of Medical
Amgen Europe

Lode Dewulf

Chief Patient Officer


n the past, numerous objections were raised to working with patients in designing and implementing clinical trials: not relevant, not scientifically valid, not allowed, not efficient, not cost effective, and so forth. One by one, these objections have proven to be myths. In fact, all accumulating (real world) evidence points to the opposite: When done well, working with patients in clinical trials is relevant, scientifically valid, allowed, efficient, and cost effective.

Today, clinical research seems to have passed a tipping point: The risk of not working with patients in designing and implementing clinical studies has become higher than the risk of working with them.

Patients bring a unique and needed expertise that complements and enhances (not replaces) expertise offered by science and medicine. Experience-based patient expertise offers value to several dimensions of clinical research:

Any clinical research sponsor ignoring these new realities will pay the price of lower likelihood of health authority approval, limited payer/HTA approval, subsequently creating limited access and thus lower appeal to potential investors.

Calmer Waters or Storms Ahead?

Working with patients is quickly becoming the new norm. The tipping point of the patient engagement journey in clinical research in fact may already be passed, a bit like having rounded a cape and discovering a new ocean. Can we hope this means calmer waters lie ahead for patient engagement in clinical trials?

Unlikely. A few storms are already gathering on the horizon:

There will undoubtedly be more and different storms on our journey, but the good news is that we are no longer traveling alone. Above all, each and every one of these gathering storms is more than a challenge–it is a REASON for patient engagement.

The title of our article is inspired upon The Patient Will See You Now by Eric Topol, Basic Books, 2015