Euro Roundup: EU regulators start actively prompting trial sponsors to make results public

RoundupsRoundups | 29 September 2022 |  By 

National medicines regulators in six European countries are now actively prompting clinical trial sponsors to publish the results of their past studies. Advocacy group TranspariMED said their efforts have been “remarkably successful” but warned that four other agencies “appear to be taking little or no action on missing drug trial results.”
 
The recent enactment of the Clinical Trial Regulation (CTR) and Medical Devices Regulation (MDR) by the European Union established new transparency provisions. CTR requires sponsors to make the results of medicine clinical trials public within 12 months of completing the study, although that requirement only applies to trials launched after January 2022. MDR imposes transparency rules on device developers. The effectiveness of the new rules will depend on the extent to which national agencies enforce them.
 
To understand how national competent authorities are approaching transparency, TranspariMED asked regulatory agencies in 10 EU member states a set of questions about their activities. The responses revealed a divergence between the approaches taken in different parts of the EU.
 
Seven of the surveyed countries—Austria, Belgium, Denmark, Finland, Germany, the Netherlands and Sweden—have legal frameworks related to the requirement for sponsors to report study results within 12 months of trial completion. Three of the countries are yet to set the penalty for noncompliance. Most of the other countries have set maximum penalties ranging from €25,000 ($24,000) to €50,000, although in Belgium sponsors can be fined up to €250,000.
 
TranspariMED found six of the countries with legal frameworks are actively prompting sponsors to make the results of their past drug trials public. The European Medicines Agency (EMA) is producing lists for national regulators, which then contact sponsors that are past the deadline for reporting their results on EudraCT. The Clinical Trials Information System is expected to provide monitoring data in the future.
 
The active outreach efforts have improved reporting. The Belgian regulatory agency told TranspariMED that results for 45% of the 577 clinical trials on last year’s list were uploaded after it contacted sponsors. In Denmark, the regulator “intensified” its talks with the sponsors of around 300 trials dating back to 2017 with missing results. The results of around 230 studies have now been published.
 
However, TranspariMED called out four other countries, including one, Sweden, that has created a legal framework, for appearing to take “little or no action on missing drug trial results.” Three of the national regulators, for France, Italy and Spain, failed to respond to “repeated requests for information” from TranspariMED. The advocacy group accused the agencies of failing to ensure results are reported.
 
“Registry data show continued weak reporting performance by many sponsors in these countries, and widespread data quality problems,” TranspariMED wrote. “Across Europe, 12 out of 15 large trial sponsors with very weak reporting records are now concentrated in just two countries: Italy and France. These regulators are failing to ensure that sponsors within their jurisdictions upload their share of the remaining 3,055 drug trial results that are still verifiably missing across Europe.”
 
Press Release
 
EMA seeks feedback on good practice guide for using real-world data metadata catalog
 
EMA has published a good practice guide for the use of the metadata catalog of real-world data sources for consultation. The catalog is intended to facilitate the discovery of data sources to generate evidence for regulatory purposes and to support the assessment of study protocols.
 
In the draft guide, EMA and the Heads of Medicines Agencies provide recommendations on how to use the catalog to identify real-world data sources suitable for specific research questions and assess the suitability of data sources for use in a study protocol. Details of those two applications of the catalog are the focus of the guide.
 
For example, the guide describes how assessments of sources should consider quality in relation to both the reliability of the primary data and the relevance of the data source. EMA has provided a use case to describe a six-step process for identifying suitable data sources. 
 
The guide also describes the metadata elements envisaged to be used in the EMA catalog. EMA is basing the structure of the catalog on a pilot project that sought to define a set of metadata on real-world sources.
 
The draft is open for comment until 16 November. EMA is aiming to release the catalog late next year.
 
Draft Guide
 
Team-NB posts position paper on hybrid quality management system audits under MDR
 
The European Association for Medical devices of Notified Bodies (Team-NB) has published a position paper on the application of hybrid audits to quality management system (QMS) assessments under the new device and diagnostic regulations.
 
In the paper, Team-NB sets out the collective position of notified bodies on the aspects that should be considered when using information and communication technologies to perform hybrid audits of QMS. Audits have traditionally been performed on site, but remote, technology-enabled elements became part of the oversight process during the pandemic.
 
Quoting the device and diagnostic regulations, the position paper states that at least a portion of a QMS audit must be performed on site. However, Team-NB sees scope for hybrid audits, in which at least one auditor is at the site but other team members participate remotely. When undertaken by appropriately qualified staff, Team-NB said the hybrid approach satisfies the requirements of the regulations.
 
The position paper states the hybrid model has some advantages over on-site audits, including increased availability of subject matter experts, less time spent traveling, safer auditing of high-risk areas, reduced risk of auditor burnout and less environmental impact. The position paper lists the QMS elements that must be assessed on site, such as the infrastructure and work environment.
 
Position Paper, More
 
MedTech Europe flags risk of ‘lack of coordination’ between regulators in AI plan feedback
 
MedTech Europe has identified a potential “lack of coordination between the different regulators within the same sector” as a challenge of the United Kingdom’s proposed approach to artificial intelligence.
 
The trade group made the comments in response to a policy paper published in July, in which the UK government proposed a sector-specific approach to AI. The plan is to establish cross-sectoral principles tailored to the distinct characteristics of AI and then task regulators with interpreting and implementing the principles within their sectors.
 
MedTech Europe “strongly” supports the sector-specific approach but sees possible pitfalls, specifically “a potential challenge of lack of coordination between the different regulators within the same sector that will have to regulate AI in their respective areas of responsibility.” In light of the risk, the trade group said it is essential that regulators in the same sector work together on joint guidance.
 
“The scope, scale and complexity of the expertise required to regulate AI and monitor compliance with those requirements effectively will require collaboration and common capability-building amongst those regulators. We believe that technical guidance, developed with input from stakeholders, will help reduce regulatory uncertainty and increase investment in AI-enabled medical technologies,” the trade group said.
 
MedTech Europe is concerned that the “failure to reach a sufficient level of international regulatory alignment in AI” may lead to “global market distortions, with subsequent impacts on international trade and investment.” As such, the trade group is encouraging the UK to take the lead on global alignment. 
 
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