Trial registration is the process whereby key details about the design, conduct and administration of planned clinical trials are made available on a publicly accessible database known as a clinical trial registry. Researchers should register trials as early as possible and ensure information such as contact details and trial status is kept up to date.
In Australia, registration must occur prospectively, that is before enrolment of the first participant. Prospective trial registration is now widely accepted as an essential part of an overall strategy for improving research transparency.
The Declaration of Helsinki, which is the cornerstone document guiding the ethical conduct of research in humans by physicians, now explicitly states that “every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.” This approach is supported by the International Committee of Medical Journals Editors (ICMJE) which includes many of the world’s leading journals. In 2004, ICMJE declared that they would not consider a trial for publication without evidence that it had been registered in a publicly accessible clinical trials registry prior to enrolment of the first participant.
The World Health Organization (WHO) considers the registration of all interventional trials to be “a scientific, ethical and moral responsibility”.
In Australia, the Australian and New Zealand Clinical Trials Registry (ANZCTR) is one of the Primary Registries in the WHO Registry Network. To register a trial, submit the details directly to Australian and New Zealand Clinical Trials Registry or an alternative ICMJE approved registry. To achieve prospective registration, the ANZCTR recommends applying for registration at the same time as ethics submission.
Trials registration is also important for participant recruitment. Registration allows people interested in participating in a clinical trial to search for relevant clinical trials on a single website. Registration also assists health professionals to identify relevant trials for their patients.
To assist people interested in participating in a clinical trial, language used in the general title and the lay summary should be brief, clear, written in plain English and easy to for a lay person to understand.