[ARTICLE] – Trial registration: different tools, same ethical principle.

As described by the World Health Organization (WHO), “the registration of all interventional trials is considered to be a scientific, ethical and moral responsibility”.(1)

The principle of trial registration is to declare the synopsis of the trial before the beginning of the study, and information can be added throughout the study until the publication of the associated results. The concept is interesting for several reasons; first the declaration of the initial hypothesis of research makes it possible to verify that the published results are still in accordance with the original hypothesis. For this purpose, most of the peer reviewed journals require the clinical trial registration number for the submission of a scientific article.

Another interesting aspect of registration is that nowadays there exists a huge database of clinical research around the world, so statistics can be easily done on any research domain (for example, to see if it is of interest, what kind of studies are conducted in a specific therapeutic area, etc.). In addition, comparing similar clinical trials can avoid unnecessary duplication of research, which is a fundamental aspect for patients and it is also interesting from a financial point of view. Furthermore, the register also serves to identify key research teams or clinical recruitment centers for a specific therapeutic area.

The best known clinical trial register is clinicaltrial.gov, where clinical trials around the world can be found and easily screened by consecutive steps; “Recruiting, Suspended, Terminated, Completed Withdrawn, etc.” Research hypotheses, eligibility criteria, location, and design are detailed, and also published study results can be attached. Clinicaltrial.gov is one of the most used registries, but in parallel, it may be necessary to use registries specific to particular geographical areas or for particular fields of application (drugs, nutritional studies). Indeed, the WHO registry network provides primary registries according to the country or location; for example, for Europe the EudraCT platform is used for studies related to drugs. (2)

Regarding the nutrition domains, notification of studies eligible for submission is required and must be done via the EFSA (European Food Safety Authority) platform (3) since the enactment of the European Transparency Regulation (Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain).

As fully described in the Declaration of Helsinki, founding text of the current clinical research regulations worldwide: “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject“. (4) So, whatever the tool, even if it is not required by an instance for the conduct of clinical trials, this should be highly considered for every clinical trial.

References:

1. WHO, Trial registration. https://www.who.int/clinical-trials-registry-platform/network/trial-registration 

2.  WHO, Primary registries in the WHO registry network. https://www.who.int/clinical-trials-registry-platform/network/primary-registries 

3.  EFSA. https://www.efsa.europa.eu/en/events/event/webinar-introduction-notification-studies-and-pre-submission-advice 

4.  WMA https://www.wma.net/fr/policies-post/declaration-dhelsinki-de-lamm-principes-ethiques-applicables-a-la-recherche-medicale-impliquant-des-etres-humains/