EPF publishes statement on the communication of clinical trial results

Transparency about the results of clinical trials is one of the key achievements of the new EU clinical trials regulation that entered into force in June 2014. EPF just released a position statement on the standards for communication on the lay summary to complement our previous paper on the publication of the trial results and the EU database (link).

Once the regulation comes into application in May 2016, the summary results of all clinical trials, irrespective of the outcome, will be published in the EU database maintained by the European Medicines Agency. These results will include a so-called “lay summary” which explains the main outcomes of the trial in the language and format understandable to lay persons.

Patients are interested in many of the same information as other stakeholders. Mostly, we want a straightforward explanation of what the trial was set up to achieve, and how it met its expectations. The result needs to be communicated in a way that is unbiased, comprehensive, relevant to our concerns, and easily understandable.

However, the Regulation itself only gives a list of elements of the lay summary (in Annex V) but says nothing about how, or in how much detail, these elements should be communicated. EPF believes that to implement the Regulation properly, these provisions must be clarified.

EPF’s key recommendations

Our key recommendations to the European policy-makers and stakeholders are:

1. A set of guidelines should be developed at EU level with the involvement of patient organisations, to ensure that the lay summaries on the EU database are of high quality.
2. We propose a dedicated working group hosted at the European Medicines Agency, including a sufficient number of patient representatives, the European Commission, regulators and industry to produce a draft guideline. The group should also consider optimising the user-friendliness of the EU database.
3. An EU-wide consultation on the draft guidelines should ensure perspectives of a wider stakeholder community will be taken into account.

We also suggest exploring the possibility of establishing a system for patient reviews of lay summaries. We are aware that the volume might be high; but there is interest among patients’ organisations for doing such work. The mechanisms and structures would need to be developed, and one possibility could be a pilot project. 

Contact: Kaisa Immonen-Charalambous, EPF Senior Policy Advisor, kaisa.immonen.charalambous@eu-patient.eu