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EFGCP Multi-Stakeholder Workshop on Communicating Clinical Trial Results to Meet Public Needs (29 May 2015)

Where: Thon Hotel EU, Brussels, Belgium

When: 29 May 2015

Why returning results of clinical trials to participants?

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 new EU Clinical Trials Regulation: making results available to the wider public

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.

Objectives of the workshop

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.

Programme

The programme is available for download below.

Registrations

To register, please fill in the registration form below and send it via post, email or fax:

  • Email it to conferences@efgcp.eu
  • Fax it to +32 2 503 31 08
  • Send it by post to the EFGCP Secretariat, Square de Meeûs, Rue de l'Industrie 4, B-1000 Brussels, Belgium

As a representative from a patient organisation, you can benefit from a waiver or one of the 10 grants available to fund your participation to the workshop. Contact the EFGCP Team: conferences@efgcp.eu

Contact

Should you have any question, please feel free to contact us at conferences@efgcp.eu or tel.: +32 2 732 87 83