Proceedings: DIA Europe 2019

The Patient At The Center:
Transforming Medical Affairs & Communications

Chris M. Slawecki
Senior Digital Copy Editor

DIA Europe 2019

IA 2019 was the first EuroMeeting to dedicate an entire theme to Medical Affairs & Communications. This debut considered the value of these functions throughout the healthcare ecosystem, a broad perspective that encompassed strategies for simplification and digitalization, engaging with patients to improve benefit-risk assessment and communication, and how to broaden patient communication and collaboration as an essential element of transforming medical affairs and communications.

Key Takeaways

  • Brilliant at the basics, fit for the future: New communication and digital technologies will continue to emerge, but old ones aren’t retired just yet; medical affairs and communications professionals must stay current with existing practices while simultaneously developing new capabilities.
  • True engagement between patients and medical affairs and communications can help patients develop a sense of ownership and empowerment about clinical trials and the products coming out from them.
  • Medical communication that results in patient engagement and empowerment brings positive change to the entire healthcare product development ecosystem.

Why this is important: Danie du Plessis, Managing Director and Owner, TheNextVersion (UK), summarized the importance of medical affairs and communications by presenting this quote from an August 2018 Medical Affairs 2025 White Paper: “Medical Affairs stands to be one of the most strategically important and valued functions in a pharmaceutical company, as the nexus of cutting-edge medical, scientific and patient-centered insights that drive strategy and innovation throughout the entire product life cycle.”

From Obligation to Opportunity: Potential of Lay Summaries

“There was a really interesting conversation–again, with input from patients–around simplifying what we share,” du Plessis explained. One example was providing lay summaries of clinical trials, required per the new EU clinical trial regulation of 2014.

In accordance with this requirement, clinical trial sponsors must submit the results of the clinical trial together with a trial summary that a layperson could be expected to understand, plus the clinical study report (where applicable), within defined timelines, to a public database.

The database that will present these lay summaries (LSs) (a) is easily searchable and (b) hyperlinks together the clinical trial protocol, the lay summary, and the clinical study report. Because they are written specifically for patients to understand, lay summaries:

  • Can be used to communicate with the general public about the disease or condition
  • Can be used to communicate with specific patients and patient groups
  • Can be used to develop patient-centric research activities
  • Can help refine internal (company) transparency processes.

45 percent of Europe’s top twenty pharmaceutical companies already post Lay Summaries; another 25 percent (70 percent total) have publically committed to post them.

TransCelerate Patient Experience Initiative

The TransCelerate Patient Experience Initiative seeks to develop patient engagement tools that contribute to an improved partnership between sponsors and patients in clinical studies. It comprises two overlapping projects that span the entire clinical research process.

Patient Protocol Engagement Toolkit (P-PET)
Design clinical studies with patient input

Target product profile => Clinical development plan => Protocol concept => Protocol optimization=>

This P-PET Toolkit includes a User Guide that guides sponsors through meaningful discussions with patient partners during clinical study protocol development; a Resource Guide with sample questions to ask patients and visual aids that clearly explain study design/protocol concepts; and feedback templates for patients and sponsors to clearly capture lessons learned.

Study Participant Feedback Questionnaire Toolkit (SPFQ)

Gather patient feedback during clinical studies
=>Protocol optimization => Protocol execution => Data analysis => Data dissemination => Post-Study
This SPFQ toolkit includes a socialization deck that helps sponsors seek support from patients and related stakeholders, an implementation user guide including templates for sponsors to collect feedback, and a three-stage survey to gain patient feedback at the beginning, middle, and end of a study.

Why is better patient communication better for everyone?

By designing clinical studies with patient input, for example, study sponsors can potentially:

  • Improve number of patients participating in clinical studies by improving that experience.
    • Improve patient adherence to clinical study procedures they helped define/develop.
    • Decrease burden of study participation by collaboratively identifying/defining the benefits and risks of participation.
  • Reduce patient study dropout rates and number of study protocol amendments.
  • Develop more “fit for patient” drugs and accelerate their delivery to the market.
  • Benefits can continue even after product launch, such as
    • Increased sense of altruism and common good among patients, from knowing that their participation may improve the lives of future patients.
    • Increased patient trust in clinical research product development, from knowing that their input has been demonstrably valued in feedback and communication processes.

According to 2018 analysis of “patient-centric trials” by the intelligence unit of The Economist, patient-centric trials took less time to recruit 100 participants (four months) compared to other trials (six to eleven months); and drugs developed using patient-centric designs had a twenty percent increased chance to be launched, compared to drugs developed without them, an improvement which is consistent across neurology, oncology, and rare disease areas.

“The world is changing too fast to be slowed down. We’ve had some examples of great outcomes but it took five years to get there. We just don’t have that luxury anymore,” du Plessis concluded.