易于理解,临床试验结果的独立事实总结有可能提高公众对药物研究的理解和参与。欧洲临床试验条例(EU)536/2014是一项重要的监管举措,将导致大量此类简单语言摘要(PLS)发布在公共领域。今天,然而,关于PLS的编写和向公众提供的程度知之甚少。
这项初步研究评估了(i)20家顶级制药公司在提高透明度和承诺以易于理解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查找它们的便利性。
公共领域PLSs的可用性是根据四个疾病领域的EudraCT技术结果摘要的数量估算的:慢性阻塞性肺疾病,哮喘,脑膜炎,和流感。使用Google评估了公众通过互联网搜索引擎查询容易找到PLS的可能性。
所有20个赞助商都承诺提高临床试验的透明度,17致力于与试验参与者分享PLS,和14在公共领域至少有一个PLS。在2017年1月1日至2020年6月30日期间,这四个疾病领域的总共99项临床研究在EudraCT上发布了技术摘要。在这99项研究中,有14项研究在公共领域有PLSs。搜索引擎直接捕获了14个PLS中的12个。然而,必须在搜索词中包括申办方试验标识符或EudraCT编号,才能找到它们.通用搜索词导致大量不相关的结果。
尽管在临床试验透明度方面取得了进展,临床试验中易于获得的PLSs目前很少。条例(EU)536/2014规定的欧洲授权和非技术成果摘要框架将是带来积极变化的重要一步。
更多的患者和公众参与医疗保健研究将有助于加快新药的制造过程。监管机构和医疗保健行业都知道这一点。医疗保健行业希望向患者和公众提供更多有关人体研究的信息。帮助实现这一目标的一种方法是编写临床研究结果的简单摘要。这里,我们使用术语“简单语言摘要”(PLS)来描述它们。PLS允许人们更清楚地了解人类研究。一项新的法律将很快使得有必要为在欧洲进行的每一项临床研究编写一份PLS。但是,今天,PLS是否被用来告知公众临床研究?它的潜力是什么?我们发现只有少数研究人员已经开始编写PLS。大多数研究的PLSs不向公众提供。即使是公共网站上的PLS也很难通过Google搜索找到。为了更好地了解PLSs的潜力,我们正在做更多的研究。这项研究将着眼于公众想要了解这些研究以及他们将如何检索这些信息。
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.
More patient and public involvement in healthcare research will help to speed the process of making new medicines. This is known by both the regulators and the healthcare industry. The healthcare industry wants to make more information on human research studies available to patients and the public. One way to help achieve this is to write simple summaries of clinical
study results. Here, we use the term plain language summary (PLS) to describe them. The PLS allows people to understand human research studies more clearly. A new law will soon make it necessary to write a PLS for every clinical
study done in Europe. But, today, is the PLS being used to inform the public about clinical research studies? And what is its potential? We found only a few researchers have already begun to write PLSs. PLSs on most studies are not available to the public. Even those PLSs on public websites are very hard to find through a Google search. To better understand the potential of PLSs we are doing more research. This research will look at what the public wants to know about these studies and how they will retrieve this information.