Finding clinical trial results for a specific drug can be challenging—but reading through them can be even more daunting. Scientific lingo and tongue-twisting terms can frustrate even the most intelligent patient.
Pfizer’s been working on the issue for a decade, but is now expanding its efforts. In May, it started sharing clinical study results in plain language in a searchable online portal open to the public. Starting next year, it will disclose all trial results using plain language summaries and begin translating them into Spanish, French and German.
Why now? Pfizer and other drugmakers are stepping up thanks to a European Medicines Agency (EMA) regulation that will require all companies to summarize trial results using plain language beginning next year.
The nontechnical, plain-language trial summaries—also called layperson summaries, lay summaries and simple summaries—all have the same goal. Make results easier to read.
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Along with Pfizer, other pharma companies at work on plain language efforts include Merck, Bristol Myers Squibb, Johnson & Johnson’s Janssen and Novartis. One group of drugmakers, including GlaxoSmithKline, Amgen and AstraZeneca, post some studies in plain language on a searchable website hosted by Informa.
While the EMA regulation is accelerating the use of easier-to-read pharma trials and results, a study by GSK researchers published last fall found adoption has yet to happen broadly.
The researchers reviewed the 20 largest pharma companies’ use of plain language in clinical trial summaries. While 17 of the 20 pharmas committed to sharing simple summaries with patients who had participated in the trials, only nine said they would share them with the public.
The researchers also discovered that only 14 plain language summaries were publicly published out of the 99 trials that had posted technical summaries in the European Clinical Trials Database.
The studies aren’t easy to find, either.
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“The few plain language summaries in the public domain are not easily detected by internet search engine, thereby limiting their utility as a vehicle to improve public health literacy on clinical trials,” the study concluded.
For Pfizer, another reason for the push is the public wants it. In a global survey, it found 88% of people think scientists should speak in easy-to-understand language.
People increasingly expect to get information tailored to their needs, J.R. Meloro, who leads global data dissemination, publications and transparency for Pfizer’s global medical and safety group, said in an email interview.
That may be why efforts like Pfizer’s more recently opened plain language study portal is getting “great initial feedback,” Meloro said. The pharma plans to drive broader awareness of the database on social media.
Using the simple summaries also fits into Pfizer’s equity goals, Meloro said.
Studies should be available “not only to researchers, but also to participants, patient advocates, caregivers, and the public at large. In a word, it is all about transparency,” he said.
