31 Oct How to optimize returns on Plain Language Summaries
By Deborah Collyar, Mat Stevens, and Catina O’Leary, Clinical Leader
The European Medicines Agency (EMA) now requires Plain Language Summaries (PLS) for clinical trials with sites in the European Union (EU), and other countries have followed suit with regulations or statements that support the EMA regulations. While the FDA has no current regulations for PLS, they fit into the Patient-Focused Drug Development (PFDD) guidance documents (1–4, both final and planned). In addition, given the FDA’s push for plain language in clinical trial informed consent forms and drug labeling, it seems likely that the FDA will adopt PLS regulations soon.
Many companies have already incorporated PLS into their transparency, data disclosure, or medical writing processes. With all the time, effort, and money that is being dedicated to writing PLS, it would be unfortunate if they did not return value to the intended audiences and to each company.
While PLS are prioritized to meet the needs of trial participants who expect summary results, those participants are not the only audience for these materials. Patients (and their family members) are also interested in the information offered by PLS once they receive a diagnosis for a medical condition. Patient advocacy groups (PAGs) use them to keep track of advances to keep their communities informed. Healthcare providers also use PLS to stay up-to-date and find new information for patients. By providing useful PLS for all these intended audiences, companies can achieve benefits from their PLS investments.
Efforts to create PLS are necessary, but not sufficient to make them effective. A PLS can do more than simply check a box on a form to meet regulatory guidelines. An effective PLS provides participants with feedback they need about expectations from a trial while providing the sponsor with valuable insights into their patient communities. Read more …