EMA to explore reviewing raw data from clinical trials in applications

Regulatory NewsRegulatory News | 12 July 2022 |  By 

The European Medicines Agency (EMA) is looking for industry participants for a pilot assessing whether reviewing raw clinical trial data improves its evaluation of marketing authorization applications (MAAs) for new medicines and post-authorization applications.
The pilot, announced on 12 July, stems from a joint workplan announced by EMA and the EU’s Heads of Medicines Agencies (HMA) to address issues related to big data in healthcare and medicines development. One of the ten priority recommendations that emerged was to launch a pilot allowing sponsors to submit raw data to allow faster evaluation of products with fewer questions. (RELATED: EMA goes all in on big data, Regulatory Focus, 17 August 2021)
Examples of raw data include records of original observations and measurements of clinical study participants, such as clinical laboratory results, imaging data and patient medical charts.
Unlike the US Food and Drug Administration (FDA), which stands apart from other regulators in this practice, EMA does not routinely require raw data in MAA or post-authorization submissions. Instead, EU regulators review clinical summaries and information reported in clinical study reports that are prepared by sponsors. Submitted data currently “does not directly allow disaggregation or any other form of further analysis,” said EMA.
Yet, EMA said that regulators may “benefit from having access to raw data during the assessment of the medicinal product. Access to raw data can assist regulators in understanding the submitted evidence and therefore inform the regulatory decisions on the benefit-risk balance of the product.”
EMA performed a retrospective review of is experiences with raw data, which included the experiences of other international regulatory agencies. The review found that allowing the submission of raw data benefits patients, regulators and sponsors.
EMA found that patients would benefit by having faster access to medicines; EU health agencies would have a better understanding of clinical study results informing their decision-making and have fewer questions related to data interpretation; and applicants would benefit by having to answer fewer questions and launching products earlier.
The pilot project is open to applicants or MAHs that are about to submit MAAs or post-authorization applications. If selected, applications will include raw data as part of their submissions.
To participate, raw data should comply with the Clinical Data Interchange Standards Consortium (CDISC) analysis data model (ADaM) and Study Data Tabulation Model (STTM) study data standards, as well as the Define -XML and Analysis Results Metadata (ARM for Define-XML).
EMA said it will choose ten applicants to participate. The pilot, which will run for two years, is expected to begin in September 2022.
At the conclusion of the pilot, EMA will organize a workshop to discuss its learnings, and plans to publish a summary report.
Those interested in applying should contact EMA via rawdatapilot@ema.europea.eu.
EMA pilot, announcement


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Tags: clinical, data, EMA, raw, trials

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