ISPOR Summit 2019
Real-World Evidence Transparency Initiative
8:00 AM – 4:00 PM
October 11, 2019
Baltimore Marriott Inner Harbor at Camden Yards
Baltimore, MD, USA
Building Trust in RWE – The Role of Study Registration
This Summit will be a forum for discussion of the work of the Real World Transparency Partnership, led by ISPOR, ISPE, Duke-Margolis, and NPC, and involving a number of other organizations and stakeholders. It will focus on the key elements needed for the creation of a common registration site for these real-world studies that will be oriented for regular use by researchers and seen as a credible registry by decision-makers. The work already completed in this effort will be presented and the future steps envisioned will be discussed with Summit attendees.
|Friday, Oct. 11, 2019|
|8:00 AM||Summit Registration|
|8:40 AM||General Welcome|
|8:50 AM||Opening Keynote|
Session 1: Transparency in RWE - Time for a Unified Approach
This session will provide an overview of the history and goals of the RWE Transparency Initiative and why it is timely, as well as its work to date. This will include a summary of the white paper and its responses. It will cover fundamental aspects of this issue including credibility vs. transparency, characteristics of studies recommended for registration (ie, HETE studies), the importance of reporting, and replicability and the totality of evidence.
Session 2: Registration site(s) - Opportunities to Optimize
A sine qua non for pre-registration is having one or more suitable registration sites. During this session, we will hear from representatives of three potential sites - clinicaltrials.gov, ENCePP, and Open Source Forum, regarding their current capabilities for registering retrospective observational studies and their plans in this area going forward. The potential to align on a common protocol template and what that might entail will also be discussed.
|11:45 AM||Afternoon Preview|
Session 3: Nuts and Bolts of Fit-for-Purpose
This session will include discussion of a number of key characteristics of a registration site needed to achieve its desired purposes. These include: a "lockbox" capability, allowing time-stamped pre-registration without making details immediately available to the public, allowing for a period of confidentiality; protocol elements needed for pre-registration to sufficiently specify the hypothesis, its supporting rationale, and how it will be tested, in enough detail to allow transparency of intended vs. actual analysis performed; the level of detail of post-analysis reporting needed to enable replication of the analysis; and potentially other considerations.
Session 4: Behavior Modification - Boosting and Nudging
In this session, aspects of registration related to the "behavioral" elements of pre-registration will be examined. What level of detail and attestation about "pre-looks" at the data are appropriate? What is the right balance between information required and overall feasibility - is some pilot testing called for? What external conditions on pre-registration would be the best incentives for encouraging its use?
Transparency in RWE - Moving Forward
This panel will reflect on the day's discussion and review the next steps needed to move towards making pre-registration common practice for RWD hypothesis-testing studies in light of both the opportunities and the challenges. Substantial time for audience interaction will be allowed.
|4:00 PM||Summit Adjourned|
*Subject to change