Context Governments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including targeted direct funding and industry tax rebates. The effectiveness of the different approaches employed is unclear. Objective To systematically review the effects of direct government financing interventions by allowing companies to reduce their tax payable on clinical trial activity. Data sources Pub Med, Scopus, Sage, ProQuest, Google Scholar and Google were searched up to the 11th of April 2022. In addition, the reference lists of all potentially eligible documents were hand searched to identify additional reports. Following feedback from co-authors, information on a small number of additional interventions were specifically sought out and included. Data extraction Summary information about potentially eligible reports were reviewed independently by two researchers, followed by extraction of data into a structured spreadsheet for eligible studies. The primary outcomes of interest were the number of clinical trials and the expenditure on clinical trials but data about other evaluations were also collected. Results There were 1694 potentially eligible reports that were reviewed. Full text assessments were done for 304, and 30 reports that provided data on 43 interventions were included– 29 that deployed targeted direct funding and 14 that provided tax rebates or exemptions. There were data describing effects on a primary outcome for 25/41 of the interventions. The most common types of interventions were direct funding to researchers via special granting mechanisms and tax offsets to companies and research organisations. All 25 of the studies for which data were available reported a positive impact on numbers and/or expenditure on clinical trials though the robustness of evaluations was limited for many. Estimates of the magnitude of effects of interventions were reported inconsistently, varied substantially, and could not be synthesised quantitatively, though targeted direct funding interventions appeared to be associated with more immediate impact on clinical trial activity. Conclusion There is a high likelihood that governments can increase clinical trial activity with either direct or indirect fiscal mechanisms. Direct funding may provide a more immediate and tangible return on investment than tax rebates.
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.
ContextGovernments have attempted to increase clinical trial activity in their jurisdictions using a range of methods including targeted direct funding and industry tax rebates. The effectiveness of the different approaches employed is unclear.ObjectiveTo systematically review the effects of direct government financing interventions and allowing companies to reduce their tax payable on clinical trial activity.Data sourcesPub Med, Scopus, Sage, ProQuest, Google Scholar and Google were searched to the 11th of April 2022. In addition, the reference lists of all potentially eligible documents were hand searched to identify additional reports. Following feedback from co-authors, information on a small number of additional interventions were specifically sought out and included.Data extractionSummary information about potentially eligible reports were reviewed independently by two researchers, followed by extraction of data into a structured spreadsheet for eligible studies. The primary outcomes of interest were the number of clinical trials and the expenditure on clinical trials but data about other evaluations were also collected.ResultsThere were 1694 potentially eligible reports that were reviewed. Full text assessments were done for 304, and 30 reports that provided data on 43 interventions were included – 29 that deployed targeted direct funding and 14 that provided tax rebates or exemptions. There were data describing effects on a primary outcome for 25/41 of the interventions. The most common types of interventions were direct funding to researchers via special granting mechanisms and tax offsets to companies and research organisations. All 25 of the studies for which data were available reported a positive impact on numbers and/or expenditure on clinical trials though the robustness of evaluations was limited for many. Estimates of the magnitude of effects of interventions were reported inconsistently, varied substantially, and could not be synthesised quantitatively, though targeted direct funding interventions appeared to be associated with more immediate impact on clinical trial activity.ConclusionThere is a high likelihood that governments can increase clinical trial activity with either direct or indirect fiscal mechanisms. Direct funding may provide a more immediate and tangible return on investment than tax rebates.
Background Clinical trials are at the heart of medical research, enabling the development and implementation of new treatments. The time it takes to commence clinical trials at sites can be long, and ethics and governance approvals are key steps on the pathway to site activation. Methods This paper explores factors influencing the times to ethics approval, governance approval and site activation. Broadly, these comprised trial characteristics (disease area and trial phase), site characteristics (public or private ownership, country) and characteristics of the ethics and governance processes (scope guidelines, mutual acceptance requirements and triage of projects by risk). Median times were compared between site initiations that were and were not exposed to each characteristic using non-parametric tests in univariable and multivariable regressions. Results There were data from 150 site activations done across 91sites, 16 trials and 5 countries. The overall median time to activation was 234 days (range 74 to 657), with ethics approval taking a median of 48 days (0 to 369) and governance approval a median of 34 days (0 to 489). Both the univariable and multivariable analyses identified associations of disease area, particularly oncology (p univariable = 0.012, p multivariable = 0.044), use of scope guidelines (p < 0.001, p = 0.020) and use of a triage process (p < 0.001, 0.043) with shorter median times for governance approval. These characteristics (all p < 0.001) plus early trial phase (p = 0.028) were also predictive of shorter median times for ethics approval in univariable analyses, but none remained predictive in multivariable models (all p > 0.054). The only factors associated with reduced overall time to site activation in both univariable and multivariable analyses were early trial phase (p < 0.001, p = 0.013) and mutual acceptance of ethics approvals (p = 0.031, p = 0.030). Interpretation Times to ethics and governance approvals were only one third of total trial start-up time. Factors influencing times to approval and activation were somewhat inconsistent across analyses, but it seems likely that the introduction of selected governance and ethics processes can reduce approval times.
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