EC Walks Sponsors Through Trial Lay Summaries
The European Commission outlined how to prepare, write, translate and disseminate lay summaries of clinical trial results, which are required by EU regulations to improve transparency.
The 85-page guidance consists of two sections: a quick guide of essentials as well as a full Good Lay Summary Practice handbook that goes into greater detail. Under EU regulations, lay summaries are required to be submitted to the Clinical Trials Information System (CTIS) by sponsors within 12 months of the protocol-defined end of a trial, six months for pediatric trials, and 30 months for nontherapeutic phase 1 trials.
In order to produce a high-quality lay summary, sponsors should follow a four-step process: planning, development, translation and dissemination, the guidance recommends.
Sponsors should start planning their lay summary during protocol development in order to budget, secure resources, establish timelines, develop a lay summary template and obtain patient input, as well as to decide how the summary will be disseminated. Sponsors should have a standard operating procedure (SOP) in place for lay summaries, the guidance notes.
In developing the lay summary, sponsors should be aware that there are 10 elements that must be included in a summary:
- Clinical trial identification (trial title, protocol number, EudraCT number and other identifiers; this can include a simple lay title);
- Name and contact details of the sponsor. The guidance notes that sponsors may need to set up procedures on how to handle public inquiry about the lay summary;
- General information about the trial (trial rationale, objectives, location, timing and possibly an explanation of the trial design);
- Population of trial participants;
- Investigational products used;
- A description of adverse events and their frequency;
- The overall results of the trial, which should explain “at a minimum, the results of the primary endpoint(s) and potentially also patient-relevant secondary endpoints;”
- Comments on the outcome of the trial stating whether the results are applicable to a specific population and describing the most significant limitations;
- Whether or not follow-up trials are expected; and
- Links to additional information.
Before translating the lay summary (which should at least produce translations in the local official language(s) of the countries where the trial took place), thoroughly review it and have a well-managed translation process in place, the guidance recommends. In addition, using glossaries and predefined terminology can help. Any translated versions should be made available as soon as possible, ideally at the same time as the source version.
Lastly, the guidance explains how it wants sponsors to disseminate their lay summaries. Sponsors are required to upload them to the EU database via the EU Portal. It’s also recommended that, in addition to directly sending the lay summary to trial participants, they share it further in a nonpromotional manner.
Sponsors’ strategies can take a direct approach, such as sharing printed lay summaries with trial participants by the investigator and/or an indirect approach through open communication mediums, such as public websites. Whichever path they choose, a strategy should be decided upon as early as filing for initial trial approval but no later than database lock, the guidance advises.
“Irrespective of the strategy implemented, sponsors should weigh the benefits against the risks of the various dissemination methods and consider partnering with the investigator to ensure a proper results communication. The best fit should be based on a proactive assessment of aspects such as logistics, timing, technology, costs, privacy, risk of miscommunication and vulnerability of the trial population,” the guidance says. “Dissemination of lay summaries beyond the EU Portal and Database requires consideration of the ethical, legal and regulatory obligations with regard to results communication, as well as a profound understanding of advantages and concerns of different dissemination strategies.”
The guidance includes an appendix of additional considerations, such as food for thought on presenting secondary endpoints, the estimated amount of hours a lay summary will take depending on trial complexity and a table of general phrases accompanied by lay language examples. It also includes an appendix list of glossaries and an appendix of guidances sponsors can refer to.
Read the full guidance here: https://bit.ly/3mxDqyY.