The effects of government policies targeting ethics and governance processes on clinical trial activity and expenditure: a systematic review

Abstract

Governments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including simplifying the ethics review and governance process of clinical trials. This study’s objective was to systematically review the effects of government actions targeting ethics reviews or governance processes on clinical trial activity. The data sources of Pub Med, Scopus, Sage, ProQuest, Google, Google Scholar and reference lists were all searched between 9/8/20 and 6/9/20. From these sources, 1455 potentially eligible reports were reviewed and full text assessments were done for 295. Thirty-eight reports provided data on 45 interventions—13 targeting ethics review and 32 targeting governance processes—were included. There were data describing effects on a primary or secondary outcome (the number of clinical trials or expenditure on clinical trials) for 39/45 of the interventions. 23/39 (59%) reported positive effects, meaning a greater number of trials and/or expenditure on clinical trials (6/11 ethics, 17/28 governance), 7/39 (18%) reported null effects (4/11 ethics, 3/28 governance) and 9/39 (23%) reported adverse effects (1/13 ethics, 8/28 governance). Positive effects were attributable to interventions that better defined the scope of review, placed clear expectations on timelines or sought to achieve mutual acceptance of ethics review outcomes. Adverse effects were mostly caused by governance interventions that unintentionally added an extra layer of bureaucracy or were developed without full consideration of the broader clinical trial approval system. Governments have an opportunity to enhance clinical trial activity with interventions targeting ethics reviews and governance processes but must be aware that some interventions can have an adverse impact.

Factors influencing the time to ethics and governance approvals for clinical trials: a retrospective cross-sectional survey

“…The positive association of governance interventions with shorter time to governance approval observed in these analyses supports the implementation of governance processes that define the scope of governance review (resulting in a median difference of 51 days) and triage projects according to risk (resulting in a median difference of 57 days). The alignment of the favourable findings for these interventions in the current analyses with positive findings for these types of interventions in prior reports provides further support for their likely value [9].…”

“…The observation that schemes that support mutual acceptance of ethics review were associated with shorter overall time to site activation provides additional support for a likely benefit from this strategy. Prior research has also identified mutual acceptance of ethics review as a priority ethics intervention and the totality of the evidence across this study and prior investigations suggests it is likely to be effective [9,17]. Based on the current data, there remains greater uncertainty about the value of scope guidelines and triaging of ethics applications though both are inherently appealing.…”

“…The latter variously operated at national, sub-national or site levels. The selection of exposures for evaluation was based on two systematic reviews that assessed factors previously reported to influence time to trial start-up [9,12]. Site initiations were also grouped into pre-2020 and post-2020 groups to explore the impact of COVID-19.…”

“…As a response to these challenges, many governments, hospitals, and clinical sites have developed processes that are designed to improve the speed and efficiency of clinical trial applications. A recent systematic review identified almost 100 reports of interventions targeting different aspects of clinical trial administration including 45 targeting ethics approval processes or governance arrangements [9]. Amongst these interventions, the review identified 'scope guidelines' (that limit ambiguities in the process and fix timelines), 'streamlined approval' (that categorise submissions by risk and triage their review), and 'mutual recognition' (where ethics committees acknowledged other committees prior reviews) as showing promise for improving ethics review processes.…”

Speed of ethics and governance approvals in Australia before and after the COVID-19 pandemic: a cross-sectional study

“…Past literature reviews show that jurisdictions seeking to reduce their ethics and governance approval times most commonly implement several such interventions and disentangling the effects of each can be di cult. 13 Some sites have recently reported use of "integrated models" where trial design and ethics review are done concurrently with members of the ethics review panel attending and contributing to project planning meetings. This was in place in at least one state in Australia during the pandemic years.…”