- 01 Aug 2022
- NEWS
Executive Summary
The EU’s big data steering group has laid out some ambitious proposals for integrating real-world evidence into regulatory decision making, as well as plans for ongoing engagement on the use and analysis of RWE with industry and other stakeholders.
Source: ShutterstockPATIENT HEALTH DATA WILL BE VITAL TO FUTURE REGULATORY DECISION MAKING
EU regulators say they expect four real-world evidence (RWE) studies to be initiated with 10 data partners through the RWE network, DARWIN, by the fourth quarter of this year, with the number of EU studies rising to more than 100 each year by the beginning of 2025.
Also in the works are the publication of a good practice guide on real-world metadata, the development of analytics tools and standardized clinical trial protocols, and regular meetings with industry and other stakeholders, according to the “Big Data Workplan 2022-2025” from the Big Data Steering Group set up by the European Medicines Agency and the EU Heads of Medicines Agencies.
The actions laid out in the workplan will make it easier to integrate data analysis into the evaluation of medicines by regulators, and will help to speed up drug development, improve treatment outcomes and allow early patient access to new treatments, the agencies say.
“Coupled with rapidly developing technology, big data can complement the evidence from clinical trials by filling knowledge gaps on a medicine, and can help to better characterize diseases, treatments and the performance of medicines in individual healthcare systems,” they add.
DARWIN EU Pilot Studies
DARWIN (Data Analysis and Real World Interrogation Network) seems to be making good progress, particularly since a coordination center was set up in February to prepare individual data use agreements with data partners. The April meeting of the DARWIN EU advisory board heard that a catalog of real-world data (RWD) sources and a catalog of observational studies are also to be created. (Also see “EU DARWIN Project To Catalog Real-World Data Sources” – Pink Sheet, 12 Jul, 2022.)
According to the 2022-2025 workplan, pilot studies with health technology assessment (HTA) bodies and payers will be developed from the fourth quarter of this year to 2024, and a pilot on the use of RWE in health emergencies will be run with the European Centre for Disease Prevention and Control (ECDC). (Also see “EMA, HTA Bodies & Payers Explore Common Ground On Use Of RWE” – Pink Sheet, 28 Jun, 2022.)
A “big data learnings initiative” is to be launched where drug filings that include big data are tracked and the outcomes assessed, with learnings being fed into EU reflection papers and guidelines. In parallel, the existing EU PAS (post-authorization studies) register will be enhanced to increase the transparency of study methods.
Stakeholder Engagement
In addition, a big data stakeholder forum, with topic-specific meetings and workshops, will be held each year during the period of the workplan. Twice-yearly industry meetings will also be held, with the first scheduled for the fourth quarter of 2022, and a network change management strategy for big data will be developed. Workshops on the benefits of RWE and DARWIN EU will be held in the third quarter of 2023.
Regulatory Network Actions
In the fourth quarter of this year, a proof-of-concept pilot will be run by the EMA’s drug evaluation committee, the CHMP, to look at the benefits and practicalities of access to individual patient data from clinical trials (raw data) in the assessment of medicines. “Learnings from the pilot will help the EU medicines regulatory network to make an informed decision on the place of raw data in regulatory decision-making,” the workplan says. (Also see “EMA To See If Reviewing Patient-Level Data Can Speed Up Drug Evaluations” – Pink Sheet, 13 Jul, 2022.)
Reports on pilot studies of the use of RWE by the EMA’s scientific committees will also be published over the next few years, culminating in 2025 in a report on RWE in regulatory decision making.
Expert advice will be strengthened through European Specialized Expert Communities (ESECs), initially on artificial intelligence and RWE, while collaboration in the analysis of raw data from clinical trials will be further developed through the setting up of a “cluster of excellence,” the workplan states.
Data Quality Framework
Also on the cards is a data quality framework for the EU medicines regulatory network that is expected by the end of 2022. This will be based on discussions on data quality with a range of stakeholders including regulators, pharmaceutical companies, academia, patients and health care professionals.
The aim of the framework is to develop guidelines, build a strengthened process for data qualification through scientific advice, and promote the uptake of electronic health records, registries and genomics data by EU member states.
European Health Data Space
These regulatory efforts will also support the proposed European Health Data Space (EHDS), the agencies say in the workplan. A European Commission proposal for a regulation on the EHDS was published in May this year.
According to the commission, the EHDS will give EU citizens control over the use of their health data, support research into new medicines and medical devices, and encourage access to and use of health data for research, regulation and policy making, while upholding EU data protection rules through a European governance framework.
Source: https://pink.pharmaintelligence.informa.com/PS146794/RWE-Studies-To-Hit-100-Per-Year-In-Europe-By-2025