Article type
Year
Abstract
Background: Clause 3.3.12 of the Australian National Statement on Ethical Conduct in Human Research 2007 (The Statement) states: ‘Before beginning the clinical phase of the research, researchers should register clinical trials in a publicly accessible register.’
Objectives: To survey Australian Human Research Ethics Committees (HRECs) to ascertain: (1) any changes in their mechanisms for promoting prospective trial registration; and (2) the proportion of approved trials that were registered on a World Health Organization-recognised clinical trials registry pre/post-publication of The Statement.
Methods: Surveys were posted to the 227 approved Australian HRECs in 2008 gathering information on any processes encouraging clinical trial registration, and up to 10 consecutive clinical trials they had approved from April 2007 (Survey#1) and from April 2008 (Survey#2). Comparisons of data pre- and post-rollout of The Statement were calculated using January 1, 2008 as the cut-off.
Results: 63/227 (28%) HRECs replied to Survey#1 and 43 (19%) to Survey#2. Of those that responded, the majority approved <10 clinical trial applications annually (Survey#1: 41%; Survey#2: 56%). The number of HRECs that included a question about trial registration on their application forms increased slightly post-publication of The Statement (Survey#1: 46%; Survey#2: 55%). 88% of HRECs in Survey#1 and 82% in Survey#2 did not include trial registration as a condition of ethics approval in their standard approval letter. Information on 339 trials was collected, with 23% (Survey#1) and 34% (Survey#2) being appropriately registered, mostly on clinicaltrials.gov (48%) and ANZCTR (31%). The main reason for not knowing whether an approved trial had been registered was that most HRECs did not collect registration information on their application form.
Conclusions: Compliance with trial registration appears to have changed little post-publication of The Statement. HRECs could play a more proactive role in improving compliance by requiring prospective trial registration as a condition of ethics approval.
Objectives: To survey Australian Human Research Ethics Committees (HRECs) to ascertain: (1) any changes in their mechanisms for promoting prospective trial registration; and (2) the proportion of approved trials that were registered on a World Health Organization-recognised clinical trials registry pre/post-publication of The Statement.
Methods: Surveys were posted to the 227 approved Australian HRECs in 2008 gathering information on any processes encouraging clinical trial registration, and up to 10 consecutive clinical trials they had approved from April 2007 (Survey#1) and from April 2008 (Survey#2). Comparisons of data pre- and post-rollout of The Statement were calculated using January 1, 2008 as the cut-off.
Results: 63/227 (28%) HRECs replied to Survey#1 and 43 (19%) to Survey#2. Of those that responded, the majority approved <10 clinical trial applications annually (Survey#1: 41%; Survey#2: 56%). The number of HRECs that included a question about trial registration on their application forms increased slightly post-publication of The Statement (Survey#1: 46%; Survey#2: 55%). 88% of HRECs in Survey#1 and 82% in Survey#2 did not include trial registration as a condition of ethics approval in their standard approval letter. Information on 339 trials was collected, with 23% (Survey#1) and 34% (Survey#2) being appropriately registered, mostly on clinicaltrials.gov (48%) and ANZCTR (31%). The main reason for not knowing whether an approved trial had been registered was that most HRECs did not collect registration information on their application form.
Conclusions: Compliance with trial registration appears to have changed little post-publication of The Statement. HRECs could play a more proactive role in improving compliance by requiring prospective trial registration as a condition of ethics approval.