Did you know . . . ?
Clinical trial sponsors will soon be required by the new EU Clinical Trials Regulation (EU No 536/2014) to provide Lay Person Summaries of the results of their clinical trials within one year of the trial ending. The summaries will be held in a publicly accessible database, managed by the European Medicines Agency (EMA).
Sponsors are required to provide information within the summary about the trial background, process, study population, medicines used and any side effects, as well as the overall results.
The EMA also now require and publish Lay Person Summaries of Risk Management Plans (RMPs) for all new medicines. RMPs describe the identified potential risks of a medicine and how these risks will be managed. They are similar to the US Risk Evaluation and Mitigation Strategies (REMS). Publishing Lay Person Summaries of RMPs aims to increase transparency and public access to relevant information on medicines.
What we do
Making research data and health information clear for the general public is a highly specialised skill. Luto are experts in creating clear health information. We have a proven track record in producing clear, high quality information for the general public.
Our team can also create templates or a house style for your documents. In addition, Luto can run workshops and train your staff to assist them to create clear Lay Person Summaries.
We have experience working with a range of organisations, including the top ten international pharmaceutical companies. We also work with medical device companies, regulatory consultancies, CROs, regulators, government departments, universities and charities.
Clinical Trials Information
In addition to producing Lay Person Summaries of trial results, we also produce a range of information materials to support clinical trials, including:
Participant Information Sheets and Informed Consent Forms
Participant recruitment materials
Educational Materials for participants and professionals
Luto can work with you to produce a high quality Lay Person Summary of your clinical trial results that is both readable and understandable. Taking your draft clinical trial summary, our experts refine the text combining our experience of information design and readability best practice. We work iteratively and involve you in every step of the process, providing explanations for suggested changes.
Risk Management Plans
Increasing numbers of regulatory documents are being made available as public or Lay Person Summaries. We have User Tested early versions of Lay Person Summaries for RMPs and found that they did not meet the needs of lay people.
Working with you to redesign Lay Person Summaries of RMPs, we can make them clear and understandable by:
Simplifying the language used, broadening accessibility
Re-structuring, making documents easier to navigate by lay people.
We can then apply our methods of User Testing to ensure lay people can find and understand the information within these summaries.
See our case study, Are Risk Management Plan (RMP) summaries fit for purpose?
For further information about Lay Person Summaries, contact the team today.