he DIA Study Endpoints (SE) Community is a forum for healthcare professionals involved in the selection, development, analysis or interpretation of study endpoints, to come together and share knowledge, with the ultimate aim of advancing the scientific development and evaluation of study endpoints for healthcare interventions.

Who Are We?

The SE Community includes over 200 members from various backgrounds across the pharmaceutical/biotech, medical device, CRO, regulatory, and consulting fields. The Community is co-chaired by Matthew Reaney and Emuella Flood and includes Keith Wenzel (Communications and Education Series), RJ Wirth (Education Series) and Bryan Bennett (Education Series) as part of its core team.

What Do We Do?

The SE Community engages in four main activities:
 

1. Educational Series: Informal webinars on timely topics, presented by Community members and invited guests, typically on the last Wednesday of the month. Topics have included:

• Patient Reported Outcomes (PROs) in rare disease
• Payer perspective on PROs in Europe
• Meaningful change and interpretation of Clinical Outcomes Assessment (COA) results.

2. Working Groups: Established to address specific challenges or knowledge gaps in the field of SE and to promote innovative methods/ideas to address these issues. Two working groups are currently ongoing; one has completed its work.

• Exploring the role of individual-level benefit-risk assessment; convened to explore how to construct and use a comprehensive individual-level benefit-risk assessment for evaluating treatment as a supplement for aggregated population-level data. Report expected by mid-2018.
• Using wearable data in SEs; convened to inform best practices, the working group includes nearly 50 members from industry, regulatory and academia. Three workstreams are underway:

• wearables evidence dossier to support use as key trial endpoint
• development of standards
• defining wearable endpoints/endpoint positioning
• Reports expected by late 2018

• Predicting Medication Adherence: Convened to define medication adherence in a drug-development context, explore the relevance of nonadherence to different stakeholders, examine data collection methods, and propose approach to predicting adherence in clinical practice. Results were published in April 2017, in Therapeutic Innovation and Regulatory Science in April 2017.

3. Participation in DIA Conferences: We convene content hubs and/or roundtable discussions in addition to community all-hands meetings to discuss current activities and generate new ideas. Events are currently in the planning stage for the 2018 DIA 2018 Global Annual Meeting in Boston.

4. Dedicated Bi-Annual SE Community Conference: The 2018 Advancing the Science of Study Endpoints conference will be held September 20-21 in Bethesda, Maryland, US. An agenda will be shared in the coming weeks. The Program Committee includes Ashley Slagle, Jason Lundy, Michael Lees, and Rene Allard, along with several of our core members.

Get Involved!

The science of study endpoints is ever-changing and constantly adapting to new developments in the pharmaceutical/biotech landscape. Diversity of membership and participation is vital to keep the SE Community informed of these developments and to keep DIA at the forefront of the SE field. We are always looking for engaged members to join our community and contribute to our activities, or propose new ones. We hope you will take advantage of the connections, information, and collaborations that participation in the community can offer. Come join us!