EFGCP Multi-Stakeholder Workshop on
Communicating Clinical Trial Results to Meet Public Needs - A Meaningful Future for Lay Summaries-
29 May 2015 - Thon Hotel EU, Brussels, Belgium
EFGCP in partnership with EATG, EGAN, EPF, MRCT, EFPIA
Returning results of clinical trials to participants allows for investigators and sponsors to honor the essential contributions and voluntarism of study participants, while improving the transparency of those trials. There are two distinct options for making clinical trial results available in lay language: on an individual participant level through the study investigator or with a more general public approach by posting aggregate results onto a webpage. Both options provide opportunities and may also pose some practical challenges.
The second option for returning results is the actual focus of the new EU Clinical Trials Regulation adopted by European legislation makers in 2014. This revised framework will bring significant advances regarding available public information about clinical research and its results compared to today’s situation. It will for the first time ensure that layperson summaries of all clinical trials will be published on an EU database, enabling trial participants to better understand the value of their contribution and increasing transparency for the general public.
We are now at a critical stage in the process where new rules have to be developed to implement legal requirements into daily practice. Pragmatic guidance needs to balance increased public information needs with seamless integration of new steps into global clinical research operations, while safeguarding the privacy of patients, preserving the scientific rigor and trust in the regulatory systems, and maintaining the incentives for investments into European biomedical research.
This workshop aims to facilitate a dialogue among stakeholders to understand the wishes and expectations of patients and share experience and best practices of sponsors. A common understanding of the opportunities and challenges of various options is essential to achieving a successful implementation of the new rules in a globalised research environment.
More concretely, basic principles and specific tools that are consistent with health literacy principles will be discussed to ensure the content of lay summaries is practical, relevant to patients, and understandable. In addition, the workshop will investigate how such summaries could best be communicated to ensure that they are reaching their intended audience to maximise their usefulness.
In summary, the discussion aims to help develop a vision and framework that addresses stakeholder needs while increasing transparency and value for public health.
Call for posters
During this event, opportunities will be offered to showcase projects/initiatives related to the return of aggregate results from clinical trials to the general public via an EU database. The poster exhibition is organised to give the audience an opportunity to learn about which ongoing activities and interesting approaches on this topic are occurring at the moment how best to make the information contained in summaries understandable and meaningful.
Should you be interested in presenting a poster, please download the Call for Posters Information & Application Form here.
Application deadline is 23 April 2015.
Call for posters