Prospective trial registration is the process whereby key details about a planned clinical trial are made publicly available on a recognised registry before enrolment of the first participant. It is widely recognised as a key strategy to increase research transparency and accountability by minimising selective outcome reporting and publication bias. Yet many researchers do not comply and there is little information on the potential reasons for this, nor how compliance could be improved.
To evaluate the reasons for non-compliance with prospective registration and the perceived usefulness of proposed mechanisms to improve prospective registration compliance.
We conducted an online survey in a random sample of 15% of researchers who had retrospectively registered their trial on the Australian New Zealand Clinical Trials Registry. It consisted of three categorical questions about the registrant’s role, reasons for non-compliance with prospective registration, and how retrospective registration may have been prevented. Free-text responses could also be added.
Survey invitations were sent to 404 registrants; 149 (37%) responded. Of these, 90 (62%) identified themselves as chief investigator, while 30% were trial co-ordinator/research staff. The majority (56%; 84/149) cited lack of awareness as a reason for not registering their study prospectively (Figure 1). This included lack of awareness of the prospective registration requirement in general, lack of awareness of the types of trials that need to be registered and not being aware of the importance of prospective registration. Lack of organisation was also common (28%), with respondents citing lack of time, forgetfulness and confusion about who was responsible for registering. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration (Figure 2).
Many researchers remain unaware of prospective registration and its importance. Linking registration to ethics approval may be a promising strategy to improve prospective registration compliance.
Patient or healthcare consumer involvement:
No direct involvement.
By making details of clinical trials publicly available prior to commencement, prospective registration enables consumers to become aware of upcoming trials and increases transparency.