The Real World Data Program is designed to increase Health Authority confidence in Real World Data (RWD) / Real World Evidence (RWE) for regulatory decision-making.
Multiple stakeholder groups can benefit from greater use of RWD, but several challenges limit uptake. Our tools provide sponsors with RWD specific:
- Tools To Consider When Engaging Health Authorities: Gaining internal sponsor cross-functional buy-in and alignment during study design on required inputs and decisions that need to be made in order to include RWD/E in regulatory decision-making.
- Considerations For Data Relevance and Reliability: Targeting data relevance and reliability to aid quality management oversight of RWD, including inspection readiness, in a manner suitable for regulatory decision-making.
Considerations For Data Relevance and Reliability
The RWD Audit Readiness Initiative drafted a functional list of key considerations of RWD quality that can assist researchers interested in using RWD for regulatory submissions. The overall goal of this list of considerations, when used in conjunction with published guidance documents from regulatory agencies and other groups of experts, is to help provide insights into what factors and circumstances may affect a Health Authority’s willingness to accept and use RWD as a basis for regulatory decision-making in the drug approval process.
Preview the draft RWD Audit Readiness Considerations Document*.
Public review period closed February 17, 2023. Should you have any questions please contact firstname.lastname@example.org and put RWD Audit Readiness in the subject line.
*TransCelerate released this document as a draft. Deliverable is still in progress.