Dataset Information

Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey.

ABSTRACT:

Background

The UK's transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science.

Methods

A survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied.

Results

Priority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for "pay for performance" products; and education and professional development.

Conclusions

The UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients' experiences and perspectives, and investing in a skilled workforce.

SUBMITTER: Cruz Rivera S

PROVIDER: S-EPMC7885762 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundOne of the key strategies to successful implementation of effective health-related interventions is targeting improvements in stakeholder engagement. The discrete choice experiment (DCE) is a stated preference technique for eliciting individual preferences over hypothetical alternative scenarios that is increasingly being used in health-related applications. DCEs are a dynamic approach to systematically measure health preferences which can be applied in enhancing stakeholder engagement. However, a knowledge gap exists in characterizing the extent to which DCEs are used in implementation science.MethodsWe conducted a systematic literature search (up to December 2016) of the English literature to identify and describe the use of DCEs in engaging stakeholders as an implementation strategy. We searched the following electronic databases: MEDLINE, Econlit, PsychINFO, and the CINAHL using mesh terms. Studies were categorized according to application type, stakeholder(s), healthcare setting, and implementation outcome.ResultsSeventy-five publications were selected for analysis in this systematic review. Studies were categorized by application type: (1) characterizing demand for therapies and treatment technologies (n = 32), (2) comparing implementation strategies (n = 22), (3) incentivizing workforce participation (n = 11), and (4) prioritizing interventions (n = 10). Stakeholders included providers (n = 27), patients (n = 25), caregivers (n = 5), and administrators (n = 2). The remaining studies (n = 16) engaged multiple stakeholders (i.e., combination of patients, caregivers, providers, and/or administrators). The following implementation outcomes were discussed: acceptability (n = 75), appropriateness (n = 34), adoption (n = 19), feasibility (n = 16), and fidelity (n = 3).ConclusionsThe number of DCE studies engaging stakeholders as an implementation strategy has been increasing over the past decade. As DCEs are more widely used as a healthcare assessment tool, there is a wide range of applications for them in stakeholder engagement. The DCE approach could serve as a tool for engaging stakeholders in implementation science.