“Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” [§35 of the Declaration of Helsinki] [1]

The registration of non-interventional studies on publicly accessible databases is a practice that embodies the ethical principles of the Declaration of Helsinki. It enhances transparency, accountability, participant protection, and the contribution to scientific knowledge, all of which are essential for conducting ethical research involving human subjects (research participants).

Recently, the FDA noted that “To ensure transparency regarding their study design, sponsors should post their study protocols on a publicly available website, such as ClinicalTrials.gov or the web page for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) for post-authorization studies” [2].

Registration of Imposed post-authorisation safety studies on the ENCePP PAS Register is a legal requirement, whereas registration on non-imposed studies is not.

Transparency and Accountability

Transparency – The Declaration emphasizes the importance of transparency in all research involving human subjects. By registering non-interventional studies, researchers make the study’s design, methodology, and goals publicly available. This openness helps build trust with the public and the research community by ensuring that the studies can be scrutinized and understood by others.

Accountability – Registering studies holds researchers accountable for the integrity of their research. It allows for the comparison of reported research outcomes with what was initially planned. This practice helps to prevent selective publication and reporting biases, ensuring that all results, whether positive, negative, or inconclusive, are accessible and can contribute to the body of scientific knowledge.

As the regulatory landscape continues to evolve, with entities like the FDA advocating for increased transparency in study designs and protocols, it becomes ever more critical for researchers to embrace the registration of both clinical trials and non-interventional studies. Doing so not only fulfils a legal and ethical mandate but also paves the way for a more informed and inclusive scientific inquiry that benefits all stakeholders involved.

References:

1. Section 35 of the World Medical Association – Declaration of Helsinki (October 2013): https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
2. Section III.B.2 of the FDA Guidance – Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (August 2023): https://www.fda.gov/media/171667/download