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How can real-world evidence aid decision making during the life cycle of nonprescription medicines?

ABSTRACT: Real-world evidence (RWE) is an emerging scientific discipline which is being increasingly utilized for decision making on prescription-only medicines. However, there has been little focus to date on the application of RWE within the nonprescription sector. This paper reviews the existing and potential applications of RWE for nonprescription medicines, using the nonprescription medicine life cycle as a framework for discussion. Relevant sources of real-world data (RWD) are reviewed and compared with those available for prescribed medicines. Existing life-cycle data gaps are identified where RWE is required or where use of RWE can complement data from randomized controlled trials. Published RWE examples relating to nonprescription medicines are summarized, and potential relevant future sources of RWD discussed. Challenges and limitations to the use of RWE on nonprescription medicines are discussed, and recommendations made to promote optimal and appropriate use of RWE in this sector. Overall, RWE currently plays a key role in specific phases of the nonprescription medicine life cycle, including reclassification and postmarketing safety surveillance. The increasing availability of patient-generated health data is likely to further increase the utilization of RWE to aid decision making on nonprescription medicines.

SUBMITTER: Csoke E

PROVIDER: S-EPMC8742642 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionA review of European Union (EU)-funded initiatives linked to 'Real World Evidence' (RWE) was performed to determine whether their outputs could be used for the generation of real-world data able to support the European Medicines Agency (EMA)'s regulatory decision-making on medicines.MethodThe initiatives were identified from publicly available websites. Their topics were categorised into five areas: 'Data source', 'Methodology', 'Governance model', 'Analytical model' and 'Infrastructure'. To assess their immediate relevance for medicines evaluation, their therapeutic areas were compared with the products recommended for EU approval in 2016 and those included in the EMA pharmaceutical business pipeline.ResultsOf 171 originally identified EU-funded initiatives, 65 were selected based on their primary and secondary objectives (35 'Data source' initiatives, 15 'Methodology', 10 'Governance model', 17 'Analytical model' and 25 'Infrastructure'). These 65 initiatives received over 734 million Euros of public funding. At the time of evaluation, the published outputs of the 40 completed initiatives did not always match their original objectives. Overall, public information was limited, data access was not explicit and their sustainability was unclear. The topics matched 8 of 14 therapeutic areas of the products recommended for approval in 2016 and 8 of 15 therapeutic areas in the 2017-2019 pharmaceutical business pipeline. Haematology, gastroenterology or cardiovascular systems were poorly represented.ConclusionsThis landscape of EU-funded initiatives linked to RWE which started before 31 December 2016 highlighted that the immediate utilisation of their outputs to support regulatory decision-making is limited, often due to insufficient available information and to discrepancies between outputs and objectives. Furthermore, the restricted sustainability of the initiatives impacts on their downstream utility. Multiple projects focussing on the same therapeutic areas increase the likelihood of duplication of both efforts and resources. These issues contribute to gaps in generating RWE for medicines and diminish returns on the public funds invested.

Project description:BACKGROUND:Humanitarian action in crisis zones is fraught with many challenges, including lack of timely and accessible research evidence to inform decision-making about humanitarian interventions. Evidence websites have the potential to address this challenge. Evidence Aid is the only evidence website designed for crisis zones that focuses on providing research evidence in the form of systematic reviews. The objective of this study is to explore stakeholders' views of Evidence Aid, contributing further to our understanding of the use of research evidence in decision-making in crisis zones. METHODS:We designed a qualitative user-testing study to collect interview data from stakeholders about their impressions of Evidence Aid. Eligible stakeholders included those with and without previous experience of Evidence Aid. All participants were either currently working or have worked within the last year in a crisis zone. Participants were asked to perform the same user experience-related tasks and answer questions about this experience and their knowledge needs. Data were analysed using a deductive framework analysis approach drawing on Morville's seven facets of the user experience - findability, usability, usefulness, desirability, accessibility, credibility and value. RESULTS:A total of 31 interviews were completed with senior decision-makers (n?=?8), advisors (n?=?7), field managers (n?=?7), analysts/researchers (n?=?5) and healthcare providers (n?=?4). Participant self-reported knowledge needs varied depending on their role. Overall, participants did not identify any 'major' problems (highest order) and identified only two 'big' problems (second highest order) with using the Evidence Aid website, namely the lack of a search engine on the home page and that some full-text articles linked to/from the site require a payment. Participants identified seven specific suggestions about how to improve Evidence Aid, many of which can also be applied to other evidence websites. CONCLUSIONS:Stakeholders in crisis zones found Evidence Aid to be useful, accessible and credible. However, they experienced some problems with the lack of a search engine on the home page and the requirement for payment for some full-text articles linked to/from the site.

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How can real-world evidence aid decision making during the life cycle of nonprescription medicines?

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