Lay Summaries for Clinical Trials
The EU Directive 536/2014 establishes the guidelines for summarizing clinical trial protocols and results for “lay people” at a literacy level appropriate for the general population across the EU (level 2 out of 5 by the IALTS scale). The Directive stipulates that the summaries need to be presented in the most appropriate format for the concerned patient population and translated to the languages of all countries where the trial took place. It is the sponsor’s responsibility, through its own or external agents, to publish these summaries on the EU trial database within 1 year of the completion of the trial.
Ongoing discussions among EU bodies, patient organizations, and industry representatives focus on ironing out the guidelines, to ensure consistency of interpretation among the different stakeholders. Involving a myriad of parties, structures, and interest groups, the process is far from complete.
Fully aware of the complex context of the new requirement, ClinSearch applies its expertise in clinical trials, on one hand, and public health communications, on the other, to provide services in lay summaries design and writing, including media-rich formats. To ensure the best possible quality of lay summaries, we cooperate with patient organizations to validate the final content and format for the concerned patient group. We then manage the translations in-house or through our preferred translation provider, according to a work flow and SOPs ensuring the best quality. The lay summaries service is part of the Scientific Consulting and Medical Writing department.
The services we offer include:
- Writing of lay summaries, design of lay summaries in media-rich formats;
- Training in lay summaries writing;
- Readability tests and translations of lay summaries in-house or through our preferred partners (global language coverage).