Patient Centricity in Clinical Trials

Opportunities in European transparency regulation EU536/2015 ANNEX V


Last month we talked about how Be the Partner gives sponsors the opportunity to become compliant with the European transparency regulation EU536/2015 ANNEX V. Today, we’d like to address the new opportunities that come with this change.

Most trials run in EU and Non-EU countries at the same time, but only EU trial patients will have the right to receive lay summaries. Posting a lay summary online and directing all trial patients to that site while only EU patients have access or, even worse, only directing EU patients there can be misleading and alerting for Non-EU participants.

Therefore sponsors need a user-friendly, responsible, and proactive way to distribute lay summaries via a central platform like Be the Partner. Furthermore, sharing lay summaries will boost the Sponsor’s image due to the fact that transparency and the outcome of a study are the core interests of patients.

Summing up, if communication between patients and sponsors reflects the true science of the data in a transparent way, sponsors gain trust and create an emotional bond.