Clinical Trials: Response to Public Consultation on Lay Summaries

EPF participated in the European Commission’s public consultation on a guideline for drafting lay summary of clinical trials results for lay persons. Welcoming these much-needed guidances, EPF provided the patient’s perspective to achieve meaningful patient involvement in research .

 

Increased transparency about the results of clinical trials is one of the key achievements of the new EU clinical trials Regulation. The summary results of all trials, irrespective of the outcome, will be published on an EU database maintained by the European Medicines Agency. This will include a so-called “lay summary”, explaining the main outcomes of the trial in a language and format understandable to lay persons.

In order to achieve meaningful patient involvement in research, it is crucial that at every stage of the research process, information is available to patients in a way that enables them to understand it. So-called “lay summaries” are needed for example at the stage of seeking funding and ethics approval. They are important not only for patients but also for lay persons and non-specialist medical professionals. The summary may need to be to be tailored according to its purpose and target audience.

Moreover, we consider the return of the results of clinical trials to the patient community as a moral obligation of investigators and sponsors. In this way, they show their respect for the vital contributions of the patients and volunteers who participate in clinical trials, while improving the transparency of research.

EPF called for EU guidance to address shortcomings of the Regulation

Regrettably, the Clinical Trials Regulation was very vague regarding the specifics of the lay summary. For instance, the Regulation says nothing about how, or in how much detail, the lay summaries should be described. This element was added by the Council at the last stage of negotiations, without any consultation with patient groups. 

For this reason, EPF published in March 2015 a position statement which called for guidelines to be developed at European level. In the following year, a working group led by the UK Health Research Authority was set up to develop a draft guideline. EPF participated in this group, together with several patient representatives and other stakeholders.

The European Commission released this draft guideline to a public consultation. Whilst we were broadly satisfied with the draft version, there are still some gaps which needed addressing so EPF submitted comment in response to the public consultation. You can read our response here.

Next steps

The working group will meet again during the autumn to review comments received during the public consultation. We will participate in the finalisation of the guideline and the implementation of the lay summaries to ensure that this very important legal provision actually results in making clinical trial results more accessible and easily understandable for patients across Europe.

Contact person:

 

Kaisa Immonen, Director of Policy.