Results of an online survey evaluating reasons for retrospective trial registration and mechanisms to increase prospective registration compliance

ID: 

191

Session: 

Poster session 1

Date: 

Sunday 16 September 2018 - 12:30 to 14:00

All authors in correct order:

Hunter K1, Seidler AL1, Askie L1
1 NHMRC Clinical Trials Centre, University of Sydney, Australia
Presenting author and contact person

Presenting author:

Anna Lene Seidler

Contact person:

Kylie Hunter
Anna Lene Seidler
Abstract text
Background:
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.

Objectives:
To evaluate the reasons for non-compliance with prospective registration and the perceived usefulness of proposed mechanisms to improve prospective registration compliance.

Methods:
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.

Results:
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).

Conclusions:
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.

Relevance:
By making details of clinical trials publicly available prior to commencement, prospective registration enables consumers to become aware of upcoming trials and increases transparency.

Attachments: 

PDF icon Figure 1.pdf
PDF icon Figure 2.pdf

Relevance to patients and consumers: 

By making the details of clinical trials publicly available prior to commencement, prospective registration enables consumers to become aware of upcoming trials they may wish to participate in, thereby facilitating recruitment. It also reduces the temptation for researchers to either not publish or only selectively publish results from completed trials. This, in turn, helps to ensure that the totality of evidence is available to inform healthcare policies and clinical practice guidelines, all ultimately enabling clinicians and patients to make well-informed healthcare decisions that are likely to lead to the best possible health outcomes.