The Value of Plain Language Summaries in Publications
Plain language summaries (PLSs) are explanations of research in terms that can be easily understood by someone without specialized training. Online content creators have been doing this informally for years, and regulatory agencies worldwide are beginning to encourage their use. Here are some reasons why you should consider writing plain language summaries to accompany your publications:
Improved patient and caregiver engagement: Understandable research increases health literacy and empowers patients to make informed decisions about their health, including choosing medicines with their healthcare providers and making decisions about whether and when to enroll in a clinical study.
Increased dissemination: By including PLSs in research publications, researchers can increase the impact of their research and increase the likelihood of it being translated into clinical practice. PLSs also allow content creators to feature the research more easily in their online publications, which will further increase the reach of the article. Additionally, PLSs can be used on company websites to help patients understand upcoming and ongoing clinical studies.
Improved transparency: PLSs can help combat misinformation, increase trust, and reduce skepticism among the public and stakeholders. Transparency is also an ethical issue. According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA), among others, researchers also have an ethical responsibility to share results of clinical studies with study participants and their families in an understandable manner.
Regulatory and ethical requirements: The European Medicines Association currently requires sponsors to submit a PLS of clinical studies within 12 months of completion (within 6 months for pediatric studies). Although this is not required by the US Food and Drug Administration, sponsors can voluntarily submit PLSs to ClinicalTrials.gov. Currently, fewer than 2% of studies include a PLS; however, there is significant interest in including PLSs in research. The PhRMA and EFPIA, for example, encourage PLSs as part of their guidelines for ethical research, and it is expected that PLSs will be required for all clinical studies in the near future.
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Pam Harvey, Director of Medical and Scientific Publications
