Euro Roundup: EC posts guidance on summary of MDR clinical investigation reports

The European Commission has released guidance on the content and structure of the summary of the clinical investigation report that sponsors need to create under the Medical Devices Regulation (MDR).

MDR requires study sponsors to submit a report of the clinical investigation within one year of the end of the trial, or within three months in the case of early termination. The sponsor must file a trial summary as part of the submission. MDR outlines the minimum requirements of the clinical investigation report and the five broad topics that should be covered by the summary.

The Commission guidance fleshes out the MDR requirements. In the guidance, the Commission reminds sponsors the submission is “a summary document” and as such “only relevant information should be supplied.” Sponsors should be “as concise as possible” when a brief description is requested and “avoid simply copying bodies of text from the full clinical investigation report.”

When writing the summary, sponsors should tailor their language to the intended user(s) of the device, taking into account their levels of health literacy and numeracy. No promotional content can be included in the document.

The rest of the guidance provides an overview of what information sponsors should include in each part of the summary, explaining that the full study title should include a brief description of the design, the experimental medical device, comparator, care provider and population of the investigation. Other parts of the summary cover those elements and other aspects of the trial in more detail.

Commission Guidance

EMA lifts business continuity measures imposed to cope with COVID-19

EMA and the European medicines regulatory network have lifted the COVID-19 business continuity measures they imposed to handle “the unprecedented operational challenges posed by the pandemic.”

Originally, EMA put measures in place to prepare for its relocation to the Netherlands and changes linked to Brexit. When the pandemic hit, the agency took steps to ring-fence resources to cope with COVID-19 while safeguarding its core activities related to the evaluation and supervision of medicines. The rest of the European regulatory network imposed measures alongside EMA in 2020.

Now, in line with its work plan, EMA has lifted the measures and is gradually resuming activities that were suspended or reduced, including the publication of clinical data. Even so, EMA said “resourcing within the entire European medicines regulatory network remains a challenge.”

EMA Notice

EMA seeks feedback on transparency rules for the CTIS

The European Medicines Agency (EMA) consulting on the rules governing the publication of information submitted through the Clinical Trials Information System (CTIS). EMA is reviewing its rules to try to balance transparency and confidentiality requirements while simplifying the process.

In its consultation document, EMA wrote that the Clinical Trials Regulation (CTR), which took effect early last year, “requires an unprecedented level of transparency and accessibility to clinical trials information” via the public interface of CTIS. EMA endorsed transparency rules in 2015, defining high level principles for system behavior for the disclosure of public information, and is reviewing its approach to build on the experience gained since the launch of CTIS.

“At the same time as delivering high levels of transparency, the disclosure rules must ensure that personal data are protected (in line with the terms of the CTIS joint controllership arrangement) and sponsors’ legitimate economic interests are protected by avoiding disclosure of information considered commercially confidential (CCI),” EMA wrote.

EMA added that it wants to “collect views from system users and stakeholders and stimulate discussions on the best possible approaches to balance transparency of clinical trials information in CTIS with confidentiality requirements, while also simplifying the modalities of use of the new system.” The agency sees the simplification of “the modalities of use of CTIS” as a way “to improve user experience and reduce the risk of data breaches.”

The EMA consultation asks respondents to say whether 13 types of structured clinical trial data and documents are critically important for publication or not, either when authorities make a decision about an application or during the trial life cycle. The list includes clinical trial design information, unexpected events, inspection reports from third countries, the protocol and the recruitment arrangements.

EMA is also seeking feedback on the deferrals it added to CTIS to enable delays to the publication of structured data and documents during the clinical trial life cycle to protect CCI. The agency wants to know if there are “compelling reasons to keep the deferral functionalities in the CTIS” and whether “CCI can be protected by means of redaction of documents without use of the deferral mechanism.”

As an interim step, EMA has created guidance on the protection of personal data and CCI while using the current CTIS transparency rules. The interim guidance describes the deferral mechanism, explaining that authorities will issue a request for information if they disagree with the proposal and that “as an ultimate measure the sponsors can withdraw their application.”

The consultation is open until 28 June. EMA expects to finalize the guidance in the third quarter.

Press Release, Public Consultation, Interim Guidance

EMA starts consultation on changing acute respiratory distress syndrome trial guideline

EMA is seeking feedback on plans to update its guideline on clinical trials of medicinal products used in the treatment of patients with acute respiratory distress syndrome (ARDS).

The current guideline dates back to 2007. Since then, professional bodies have revised the definition of ARDS “focusing on feasibility, reliability, validity, and objective evaluation of its performance,” EMA said in a draft concept paper. The “considerable heterogeneity of the patient population generally included in ARDS studies” means “it is important to accurately define baseline characteristics,” EMA wrote.

EMA began work on the revisions after requests for scientific advice revealed several issues are central to development programs. As such, EMA sees a need to “re-consider the EU regulatory expectations with regard to the data that should be generated to support the approval of novel agents.” The agency cited primary and secondary endpoints, time of assessment and stratification as areas of focus.

Currently, all-cause mortality is the preferred primary endpoint for confirmatory studies. The concept paper states that “mortality remains an important parameter for the regulatory decision and effects on mortality should be quantified with due precision,” but also sees scope to use the composite endpoint “alive at Day 28 and no more need for invasive mechanical ventilation” in randomized controlled trials.

EMA is accepting feedback until 31 July.

Concept Paper

EFPIA welcomes unofficial EU paper that calls for ‘drastic steps’ to secure drug supply

Big pharma trade group EFPIA has welcomed an unofficial paper that says the European Union “must take more drastic steps to improve the security of medicines supply.”

The “non-paper,” a type of document issued informally to facilitate negotiations, was create by 19 EU Member States including France, Germany and Italy. In the document, the member states discuss the current situation before issuing their call for drastic steps.

The member states propose three points of action: installing a voluntary solidarity mechanism to, as a last resort, temporarily alleviate acute shortages; establishing a European list of critical medicines whose supply, production and value chains must be monitored; and exploring a Critical Medicines Act to reduce dependencies for critical medicines and ingredients.

In its response, EFPIA said it “welcomes the non-paper” and agrees “on the need to take a multi-faceted approach, and to build on existing momentum” without commenting on the specific proposals.

EFPIA Statement, Non-paper

Euro Roundup: EC posts guidance on summary of MDR clinical investigation reports

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