Table 1 Solutions for embedding CETs
From: Normalising comparative effectiveness trials as clinical practice
Barriers to embedding | Possible solutions |
|---|---|
The lack of a culture of continuous improvement where knowledge creation is explicitly recognised as a core activity of the health system | - Introduce health system accreditation acknowledging centres of excellence based on indicators of research activities. - Incentivise Chief Executive Officers and board members to advance the role of research in their organisations. - Improve health system leader buy-in by more closely aligning research activity with health system priorities. - Improve stakeholder buy-in by structuring learning to focus on the outcomes of care delivery, increasing return on investment, and decreasing costs. - Engage all stakeholders to create widespread awareness of the pivotal role clinical research plays in the generation of high-quality evidence and improved health outcomes. - Restructure workflow to incorporate research activity with protected time and provide incentives for clinicians who contribute to research-driven clinical improvements. - Support studies conducted by investigator networks to address real-world evidence gaps. |
Failure to apply risk-proportionate governance practices to CET | - Ensure proportionate approaches to trial ethics and governance approval that expedite study approval when trial risks are low - Utilise existing flexibilities in trial regulation to improve trial conduct (e.g. the use of flexible, patient-supported approaches to informed consent). - Ensure governance arrangements for CETs balance a trial’s risk against the risks posed by current, unresearched care. - Ensure that patients are involved in trial governance decisions and the design of research ethics and regulatory systems. |
Difficulties designing and conducting large, efficient CETs | - Harmonise requirements for trial conduct to facilitate international collaboration. - Ensure trial networks collaborate with consumers and frontline clinicians to share expertise and knowledge and to drive more efficient trial practices. - Utilise novel trial designs that minimise disruption to clinical workflows. - Utilise trial platforms to create a coordinated approach to evidence generation - Incorporate implementation science strategies into CETs to facilitate uptake of evidence-based practice. - A cost-effectiveness analysis into, or alongside trials. |
Limited engagement from patients and the public as active partners in advancing the delivery of care | - Introduce health system accreditation for ‘partnering with consumers’ to develop clinical trials operations so that research policies and practices reflect the needs and preferences reflect the needs and preferences of service users. - Co-design with patients a communication strategy to widely broadcast research as a core activity of the health system and that data and tissue is used to improve care within a framework that safeguards privacy and confidentiality. - Assist/enable patients to prioritise research questions so that the questions investigated, and the outcomes chosen are those most important to them. - Involve patients in the design of research so that it is conducted in ways that are sensitive to participants’ needs (e.g. by minimising the burden of participation). |