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.
Tools To Consider When Engaging Health Authorities
The following tools were developed by leveraging RWE case studies to delineate a reliable, streamlined, & scalable approach for interactions with Health Authorities for regulatory decision-making. The considerations may help to clarify regulatory requirements on RWE use to supplement or replace clinical trials.
Solution Overview: Preparing to Engage with Health Authorities on Real World Evidence for Medicines
This companion presentation provides a general overview and supports the socialization of the TransCelerate Biopharma Real World Data solution, “Preparing to Engage with Health Authorities on Real World Evidence for Medicines”.
This resource was developed by a cross-functional team of TransCelerate member company representatives, with a goal to support pharmaceutical companies in the preparation for engagement with Health Authorities in discussions on real world evidence.
Preparing to Engage with Health Authorities on Real World Evidence for Medicines: A TransCelerate Perspective
Provides various options for Sponsors to consider on when to engage with Health Authorities, the type of input, and decisions needed to come to a mutually transparent path forward to include RWE in regulatory decision-making for defined use cases.
Download now: Preparing to Engage with Health Authorities on Real World Evidence for Medicines: A TransCelerate Perspective
Preparing to Engage with Health Authorities on Real World Evidence for Medicines Infographic
Provides a visual overview of the Health Authority Engagement Considerations including key methodologies, Health Authority interactions, and illustrative Case Studies for a broader understanding of the Preparing to Engage with Health Authorities on Real World Evidence for Medicine paper.
Download now: Preparing to Engage with Health Authorities on Real World Evidence for Medicines Infographic
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 feedback@transceleratebiopharmainc.com and put RWD Audit Readiness in the subject line.
*TransCelerate released this document as a draft. Deliverable is still in progress.