Wilcox Charles S, Franceschi Leslie, Simmons Adam
Dr. Wilcox is Chief Executive Officer at Praxis Research Consulting in Newport Beach, California.
Ms. Franceschi is Senior Project Director at Syneos Health in Morrisville, North Carolina.
Innov Clin Neurosci. 2020 Jul 1;17(7-9):41-44.
The much-anticipated 2014 European Union (EU) Clinical Trial Regulation requiring Layperson/ Plain Language Summaries (PLS) is slated for implementation in 2020. At the 10th Annual CNS Summit Conference (Fall 2019), a panel discussion was convened with the objective of evaluating the likelihood of the PLS legislation being implemented successfully in the EU and voluntarily (e.g., pro-actively) in the rest of the world. Points of the discussion embraced the notion that this is an excellent opportunity for the entire pharmaceutical industry. Moreover, in the United States, public opinion of the pharmaceutical industry hit an all-time low in 2019, surpassing the oil industry with regard to public distrust. For decades, clinical trial participants have stated that wanting to learn, in layperson terms, the results of the study was second only to wanting to learn the treatment group into which they were assigned under double-blind conditions. Our conclusion is that while confidentiality, commercial interests, total costs, regulatory concerns, as well as some operational aspects (i.e., patient access portals) are among the hurdles, our commentary strongly advocates systematic implementation not only within the EU, but that this should be implemented globally, without further delay.
备受期待的2014年欧盟（EU）临床试验法规要求提供非专业人士/通俗易懂的总结（PLS），定于2020年实施。在第十届年度中枢神经系统峰会会议（2019年秋季）上，召开了一次小组讨论，目的是评估PLS立法在欧盟成功实施以及在世界其他地区自愿（例如主动）实施的可能性。讨论要点包括这对整个制药行业来说是一个绝佳机会的观点。此外，在美国，2019年公众对制药行业的看法跌至历史最低点，在公众不信任方面超过了石油行业。几十年来，临床试验参与者表示，想用非专业术语了解研究结果的愿望仅次于想知道自己在双盲条件下被分配到哪个治疗组的愿望。我们的结论是，虽然保密、商业利益、总成本、监管问题以及一些操作方面（即患者访问门户）是障碍之一，但我们的评论强烈主张不仅在欧盟内部进行系统实施，而且应该在全球范围内立即实施，不再拖延。
