GSK, Wavre, Belgium.
GSK, Rockville, MD, USA.
Pharmaceut Med. 2020 Dec;34(6):401-406. doi: 10.1007/s40290-020-00359-4. Epub 2020 Oct 28.
Easy-to-understand, stand-alone factual summaries of clinical trial results have the potential to improve public understanding of and engagement with pharmaceutical research. The European Clinical Trial Regulation (EU) No. 536/2014 is a major regulatory initiative that will result in a large number of such plain language summaries (PLSs) posted in the public domain. Today, however, little is known about the extent to which PLSs are written and are available to the general public.
This preliminary study assessed (i) 20 top pharmaceutical companies' positions on improving transparency and commitment to disclosing trial result summaries in an easy-to-understand format and (ii) the availability of such summaries in the public domain and the ease of locating them via general web searches.
The availability of PLSs in the public domain was estimated based on the number of EudraCT technical result summaries in four disease areas: chronic obstructive pulmonary disease, asthma, meningitis, and influenza. The likelihood of PLSs being easy to find through internet search engine queries by members of the public was assessed using Google.
All 20 sponsors had committed to improve clinical trial transparency, 17 committed to sharing PLSs with trial participants, and 14 had at least one PLS available in the public domain. A total of 99 clinical studies in these four disease areas had technical summaries posted on EudraCT between 1 January 2017 and 30 June 2020. Of these 99, 14 studies had PLSs in the public domain. A total of 12 of 14 PLSs were directly captured by search engine. However, the sponsor trial identifier or EudraCT number had to be included in the search term to locate them. Generic search terms resulted in large volumes of non-relevant results.
Despite the progressive movement towards clinical trial transparency, easily accessible PLSs on clinical trials are currently scarce. The provision of a European mandate and framework for non-technical result summaries by Regulation (EU) 536/2014 will be a major step to bring about positive change.
易于理解、独立的临床试验结果摘要有可能提高公众对药物研究的理解和参与度。欧盟临床试验法规（EU）No.536/2014 是一项重大监管举措，将导致大量此类通俗易懂的摘要（PLS）在公共领域发布。然而，目前人们对 PLS 的编写程度以及公众获取 PLS 的程度知之甚少。
本初步研究评估了（i）20 家大型制药公司在提高透明度和承诺以通俗易懂的格式披露试验结果摘要方面的立场，以及（ii）此类摘要在公共领域的可用性以及通过一般网络搜索找到它们的难易程度。
根据慢性阻塞性肺疾病、哮喘、脑膜炎和流感四个疾病领域的 EudraCT 技术结果摘要数量，估计了公共领域中 PLS 的可用性。通过公众使用谷歌搜索引擎查询，评估了通过互联网搜索引擎查询找到 PLS 的可能性。
所有 20 家赞助商都承诺提高临床试验透明度，17 家赞助商承诺与试验参与者分享 PLS，并且 14 家赞助商至少有一份 PLS 在公共领域可用。在 2017 年 1 月 1 日至 2020 年 6 月 30 日期间，EudraCT 上发布了这四个疾病领域的 99 项临床研究的技术摘要。在这 99 项研究中，有 14 项研究的 PLS 在公共领域。搜索引擎直接捕获了 14 个 PLS 中的 12 个。但是，必须在搜索词中包含赞助商试验标识符或 EudraCT 编号才能找到它们。通用搜索词会产生大量不相关的结果。
尽管临床试验透明度逐步提高，但目前易于获取的临床试验 PLS 仍然稀缺。法规（EU）536/2014 为非技术结果摘要提供了欧洲授权和框架，这将是带来积极变革的重要一步。
