Graham R McClelland
King’s College London, UK
Title: Evidence-based patient involvement in medicine development
Biography
Biography: Graham R McClelland
Abstract
Statement of the Problem: Patient engagement is increasingly being encouraged by regulatory authorities and adopted by pharmaceutical companies. However, the involvement of individual patients and/or their carers, and/or representatives from patient organisations has been inconsistent and based upon a moral view rather than objective evidence of benefit. This work here attempts to begin to build an evidence-based approach to patient engagement in medicine development. Methodology & Theoretical Orientation: Firstly, a systematic literature review was conducted to conceptualise the meaning of patient engagement, to investigate current models and frameworks, and to identify key elements by a thematic analysis. Secondly, semi-structured interviews were conducted with industry practitioners to identify potential metrics for patient engagement. Thirdly, members of the UK Association of Medical Research Charities (AMRC) were surveyed on how they provide patient opinions. Findings: The systematic literature review identified 25 relevant articles, which generated eight themes on ‘how’ to engage patients in medicine development – 1. The need for a meta framework, 2. Metrics, 3. Capacity, 4. Roles, 5. Partnership, 6. Culture change, 7. Legal agreement, 8. Digital platforms. Plus, five themes on ‘where’ to engage patients in medicine development – 1. Clinical trial design and planning, 2. Clinical trial priority setting, 3. Clinical trial conduct, 4. Communication, 5. Committee membership. Interviews with nine experienced pharmaceutical industry practitioners showed that methods for assessing the amount, quality and value of patient engagement is currently lacking. 24% of the membership of the AMRC responded to the online survey, of which 86% had experience in providing patient representation in medicine development, and used a variety of methods to provide input, but 77% had not received any training on patient engagement. Conclusion & Significance: As patient engagement becomes increasingly common, there remains a need for more scientific evidence, metrics and education.