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 is proud to present the white paper Assuring Audit and Inspection Readiness – Considerations for the Use of RWD and RWE in Regulatory Decision-Making.
Download now: Assuring Audit and Inspection Readiness – Considerations for the Use of RWD and RWE in Regulatory Decision-Making
Publish Date: December 2023
This list of key considerations for RWD quality has been developed to assist researchers interested in using RWD for regulatory decision-making. Its purpose is to provide greater clarity as to the type of information and documentation regulators may request from data providers and sponsors of research about the sources and process by which RWD/RWE is compiled to inform a regulatory decision. When used in conjunction with published guidance documents from regulatory agencies and other groups of experts, this document can 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.
Development of the Considerations White Paper Infographic
The RWD Audit Readiness Initiative has developed a complimentary infographic that depicts the process by which the set of audit readiness considerations were developed. The infographic summarizes the types of input collected (i.e. literature review, interviews, survey, public review) and the broad group of process stakeholders engaged who provided expertise in the collection and aggregation of real-world data.
Download now: Development of the Considerations White Paper Infographic