Medical Organizations Ask for FDA Guidance on Plain Language Summaries of Clinical Trials

June 21, 2017

ASCO joined more than 35 other organizations, including professional societies, patient advocacy groups, and research institutions, to encourage the U.S. Food and Drug Administration (FDA) to develop a guidance on plain language summaries for clinical trial results.

In a letter to the agency, the medical organizations emphasize the importance of clearly communicating clinical trial results to the general public, and, more importantly, to patients who participated in the trial. Communicating results of clinical research in effective and transparent ways helps participants learn about the study results and recognize that their contributions to science and public health are valued, according to the organizations.

The letter was submitted along with a draft guidance for FDA consideration. The organizations assert that an FDA guidance on this topic would help sponsors and investigators develop and disseminate effective and harmonized plain language summaries of study results. The suggested guidance includes an overview of content to include in summaries as well as recommendations on timely delivery of summaries to research participants and the general public.

Read the letter and accompanying recommendations submitted for consideration.