How do you thank someone for taking part in a clinical trial? Evidence is mounting that an effective way to thank study volunteers is to provide them with a plain-language summary of the trial results. Plain, or lay-language summaries, distill the findings of the clinical trial into a brief summary that is understandable to the general public. Various studies show that most participants want the results of their trial but they are not consistently receiving them. In addition to the results, plain-language summaries provide participants with a greater general understanding of the trial. Providing these summaries is shown to improve the overall satisfaction with trials and a higher likelihood for future clinical trial participation.
While the primary purpose of the summaries is to inform study volunteers of the outcome of the trial, they are also a good tool for anyone who is interested in the trial, from medical professionals looking for a quick summary, to family members who want to understand the contribution their loved one has made.
Plain-language summaries are necessary because there are few alternatives for participants to find trial results. Motivated participants may search for the trial on a registry, like ClinicalTrials.gov, or in medical literature, but these sources are difficult to understand and may not be the appropriate options for non-specialists.
Providing plain-language results to participants will soon become mandatory for studies conducted in the European Union because of the EU Clinical Trial Regulation, which is anticipated to go into effect in 2019. Patient advocacy and other interested groups are also increasing the pressure to provide these trial results summaries. Many sponsors and researches are already preparing summaries in advance of the regulation, even for studies that will not require summaries from the EU. Even though it’s not mandatory, many trial participants will be saying a big “Thank you!”
Guest Contributor Francine Lane is a product management professional who believes that to helping users solve their problems is the key to success. She has experience bringing enterprise-level software from conception to market in a regulated environment and has over 13 years of experience in life sciences with a specialization in clinical trial disclosure. With more than 12 years working with clinical trials disclosure and transparency requirements, she is a subject matter expert in global disclosure regulations. Most recently, she leads an industry working group analyzing a new regulation known as the ‘Final Rule’ that updates the US disclosure requirements. In this capacity, she works closely with members of the National Institutes of Health (NIH) who are responsible for interpreting and implementing the regulatory changes. Francine has been a member of the TrialScope team since it acquired the PharmaCM product suite in 2014.
This article was reprinted from Volume 24, Issue 11, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact email@example.com. Subscribe >>