Summary of the meeting between Trials@Home and the EFPIA ICH (E6) Support Group

On 17 January 2024, on behalf of Trials@Home, Mira Zuidgeest (UMCU), Megan Heath (Sanofi), Hamidou Traore (UCB), Helga Gardarsdottir (UU), Solange Rohou (AstraZeneca), and Philippe Bordes (Sanofi) met with members of the EFPIA ICH E6 (R3) Support Group and EC colleagues from ICH E6 (R3) EWG Annex 1 and Annex 2

During the meeting Trials@Home presented on general aspects of the consortium, followed by a presentation on specific operational and regulatory learnings related to the RADIAL trial. Challenges that were discussed included eConsent, Direct-to-patient (DtP) IMP shipment, and data flows. The presentation was well received with interesting discussions afterwards.

Amongst others, one of the aspects that was specifically discussed was that while guidance on DCT elements in Recommendation paper and Document on national provision are available, the Trials@Home members noted that the granularity of these guidance and the level of detail needed for sponsors is sometimes not in line.

They also noted that the Recommendation Paper and Document on national provision could perhaps focus on specific local requirements. It was also highlighted that the involvement of local HCPs could be better outlined.

The EFPIA Support Group welcomed all the feedback and noted that they would be happy to receive formal feedback from Trials@Home on the EMA guidance paper. The public consultation of Annex II should be launched in April 2024.

The EFPIA Support Group is also very much looking forward to the final outcome of Trials@Home and kindly asked the members to share any valuable information with EFPIA.