12 Aug Examining the current value of ClinicalTrials.gov listings for patients and the public
Looking beyond regulatory compliance.
By Elisabeth Moore, Kimbra Edwards, and Kenneth A. Getz, Applied Clinical Trials
Providing the public with clear, understandable descriptions and results of clinical trials is imperative to fostering public trust in clinical trials and approved vaccines and treatments. The unprecedented accessibility and spread of misinformation about investigational and approved medical therapies in recent years has increased the need for centralized, accessible, and accurate information on clinical trials and their results. Patients and the public need access to reliable clinical trial results to make educated and informed decisions on treatment, in coordination with their physicians, who also need usable data to inform clinical care. This has recently become even more urgent, given the highly publicized controversies over vaccines for COVID-19, despite data suggesting that they are safe and effective.
Prior to the last decade, registrations of clinical trials, as well as their results, were generally contained only in highly technical documents, such as clinical study reports and peer-reviewed medical journals. These technical results assume an in-depth knowledge of clinical trial terminology, medical jargon, and scientific concepts. Even expert analysis of such documents can be time consuming. Meanwhile, health literacy rates among the public are quite low. A survey of eight European countries found that half of adults had deficiencies in health literacy skills. This number is even lower in the US, where only 12% of adults were found to be proficient in health literacy. Thus, for accurate, unbiased, and reliable clinical trial results to be accessible, they must be written in plain language.
In 2004, the International Committee of Medical Journal Editors (ICMJE) addressed these concerns with a trial registration policy for all publications in ICMJE journals, where associated clinical trials would be required to be posted in a public registry, such as ClinicalTrials.gov. In 2007, the US Food and Drug Administration (FDA) Amendments Act followed up by mandating that trial sponsors register the results of clinical trials on ClinicalTrials.gov, for all late-stage efficacy studies and approved products. The Plain Writing Act in 2010 requires the production of plain language communications and informed consent documents for US federal agencies. In 2016, the Final Rule update clarified FDA requirements and expanded the scope of clinical trials that are required to be listed on Clinical Trials.gov. The European commission also issued regulation (Annex V of the 2014 European Union Clinical Trial Regulation (No. 536/2014; Article 37), that mandated the creation and dissemination of plain language summaries for clinical trials completed in EU member states. These summaries state, in an unbiased, non-promotional, and patient-centric way, what happened in a clinical trial. This mandate went into full effect on January 31, 2022. Taken together, these developments have led to an increase in focus on communicating scientific and medical findings in publicly accessible and plain language. Read more …