EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation

Early results from an ongoing EU pilot on the use of clinical trial raw data in medicines evaluation have pointed to many benefits. These include fewer questions for companies and greater clarity for regulators on information submitted in marketing authorization dossiers.

Internet, business, Technology and network concept.Clinical trial 3D illustration
Access to clinical trial raw data can help regulators better understand the evidence submitted in marketing applications • Source: Shutterstock

The interim results of an ongoing pilot at the European Medicines Agency indicate that using individual patient-level data from clinical trials (also called raw data) in regulatory procedures for initial marketing authorization applications (MAAs) and post-authorization applications can enhance the evaluation process.

Key Takeaways
  • After an EU proof-of-concept pilot investigating the benefits of visualizing and analyzing clinical trial raw data to support the scientific assessment of medicinal products reached its mid-way point in December 2023, surveys were conducted with pilot participants.

There are “clear early signals confirming the added value of regulatory access to raw data in support of the regulatory...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By 

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

More from Geography

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.