TrialScope's Guide to Plain-Language Summaries

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Lora Killian Clinical trial transparency and disclosure expert and co-founder of ClaritiDox In the European Union, under the Clinical Trial Regulation sponsors are required to provide a plain-language summary for every study conducted there. The regulation requires all sponsors conducting clinical trials, including academia, to draft a lay or plain-language summary for phase 2-4 clinical trials within 12 months from the close of the trial. For pediatric trials, plain-language summaries (PLS) are required within six months of the study's completion. The U.S., however, only mentions PLS in the Final Rule for Clinical Trials Registration and Results Information Submission of the Food and Drug Administration Amendments Act of 2007, known as FDAAA 801. While trial summary results are required to be posted on ClinicalTrials.gov for most studies, PLS are not. I think one of the greatest changes was the intention of ClinicalTrials.gov to share study results with the public. It was meant to be plain language. It's actually really complex. Lora Killian, clinical trial transparency and disclosure expert and cofounder of ClaritiDox, says there is a movement among sponsors to incorporate plain-language summaries into their processes, well in advance of the EU clinical trial regulation going into effect "They are hearing the voices of patient advocates and hearing that this is important. Patients have voiced that when they participate in a trial © 2019 TrialScope, Inc. All rights reserved | trialscope.com A TrialScope Primer: The Official Guide to Plain-Language Summaries and they give up their time, and then at the end of the trial they don't hear back, they don't know what the conclusion is. It's like someone broke up with them over text." Patient advocacy groups have been extremely successful in helping sponsors see the need to communicate directly with patients who have participated in one of their studies, says Kimberley Green, clinical trial transparency and disclosure expert and co-founder of ClaritiDox with Killian. Given the undeniable fact that the pharmaceutical industry as a whole is struggling with a somewhat negative public perception, plain-language summaries are helping improve companies' brand perception. They also help sponsors recruit participants, by creating a connection between the companies and patients. Says Killian: People have a tendency to share their experiences, so if they had a positive conclusion by receiving trial results, they will share that and other people will be more likely to participate in subsequent trials. Driving forces behind PLS

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