Clinical trials registration
Clinical investigation of a product’s health benefits is based on careful design and accurate conduct of a human clinical trial. As encouraged by governments and scientific organizations, this should be complemented by the registration of a clinical trial within a publicly accessible platform. Registration, i.e. the publication of particular information on trial design, conduct, and administration in a registry, serves a number of purposes, which benefit both the public and the scientific community. Availability of information on planned or ongoing trials enables potential participants and referring physicians to decide upon enrollment. Among the ethical reasons for trial registration is the “return” to study participants in terms of available information on trial outcomes. Furthermore, by providing transparency, registries promote synergies for performing high quality and state-of-the-art clinical trials. The World Health Organization (WHO) established the International Clinical Trials Registry Platform (ICTRP) with the aim to “strengthen the validity and value of the scientific evidence base” by ensuring “that a complete view of research is accessible to all those involved in health care decision making”.
Given these benefits, trial registration including report of study results upon its completion is encouraged by the WHO and the International Committee of Medical Journal Editors (ICMJE), and it is stated as part of the revised version of the Declaration of Helsinki (2008). In the USA, clinical trials registration is required by law, as laid down in the FDA Amendments Act of 2007 (FDAAA 801). While this law applies to certain human trials of drugs, biologics, and medical devices, registration is recommended for products of other regulatory categories such as food supplements as well, as it reserves the chance of subsequent publication of study results in a prestigious scientific journal. Upon decision by the ICMJE, since 2005, registration of a human clinical trial is a prerequisite for it to be accepted for publication in a scientific journal.
A growing number of registries exist, with clinicaltrials.gov being the first and currently the largest database. It is managed by the National Library of Medicine at the National Institutes of Health and, at present, contains more than 250,000 observational and investigational trials conducted worldwide. Among the other platforms that belong to the WHO network and, thus, are accepted by the ICMJE, are the United Kingdom’s ISRCTN registry, the German Clinical Trials Register (DRKS), and the EU Clinical Trials Register (EU-CTR).
Human trials should be registered before enrolling the first subject (but no later than at the time of first enrollment), should be updated in a timely manner, and the results should be summarized after study completion. Depending on the statutory requirements of the registry, registration can be performed by the sponsor of the trial, the designated principle investigator, or a third party such as a contract research organization (CRO).
a&r comment: Publication of promising study results should not be hampered by a lack of trial pre-registration. Therefore, when commissioning a CRO with the design of a clinical trial, registration should also be considered. Given its experience and competence, a&r can provide support in trial registration, including choice of registry and compilation of appropriate information. Please contact us at firstname.lastname@example.org for more details and support.