New Toolkit Supports Digital Endpoints in Drug Development

The Digital Medicine Society (DiMe), Anthem, Biogen, Eli Lilly & Company, Evidation, Janssen, Merck, Pfizer, and Savvy Co-op recently launched a toolkit of resources to support organizations developing digital endpoints as valuable evidence in drug development. 

Pharma and payers must work together to define the evidence needed to support the value of new, digitally generated data to patients' lives. 

Therefore, the 3Ps of Digital Endpoint Value (3Ps) toolkit followed a series of workshops with global regulators, health technology assessment (HTA) bodies, public and private payers, industry sponsors, health economists, and clinical and patient experts. 

In 2019, DiMe launched the first crowdsourced library specifically focused on industry-sponsored studies of new medical products or new applications of existing medical products. 

The number of digital endpoints being used to answer questions and studied in industry-sponsored trials about new therapies has grown by 790% since the 2019 launch. Now, the library includes 225 unique statistical endpoints. 

"By launching these new recommendations and resources, we are the first to recognize and address the need to ensure that evidence from digital endpoints is developed in a way that is acceptable to payers as well as regulators," Jennifer Goldsack, CEO of DiMe, said in the announcement. 

"We applaud the forward-looking vision of our partners in this project and are proud to make these resources available in advance of any delays in making effective new treatments available to the patients who need them," Goldsack continued. 

Researchers use digital measures to inform decision-making, identify likely responders to new therapies, and diagnose patients earlier in their disease. And industry collaboration is vital to speed the development and drive broad acceptance of digital measures as digital endpoints for use in medical product development. 

In March 2022, the FDA issued draft guidance recommending digital health data acquisition in clinical investigations, furthering the widespread speculation that regulatory acceptance is not far ahead. 

"Until industry starts to coalesce around the most important and high-value digital measures of health, progress towards a shared understanding of how these new digital endpoints reflect health status will be slow," "Jennifer Goldsack, co-founder and CEO of the Digital Medicine Society (DiMe) said in an interview with PharmaNewsIntelligence.