The opportunity for greater patient and public involvement and engagement in drug development and regulation

Aiyegbusi, Olalekan Lee; Rivera, Samantha Cruz; Oliver, Kathy; Manna, Elaine; Collis, Phil; King‐Kallimanis, Bellinda L.; Bhatnagar, Vishal; Herold, Ralf; Hopkins, Jon; Campbell, Lisa; Croker, Alysha; Leach, Myles; Calvert, Melanie

doi:10.1038/d41573-023-00031-x

Cited by 3 publications

(2 citation statements)

References 3 publications

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“…Understanding caregiver experiences of amblyopia and its treatment on the child and family, as well as their perspectives on the design and conduct of clinical trials for amblyopia could potentially help in optimising disease management. This is also in line with increasing efforts from regulatory agencies worldwide to ensure that the patient voice remains central to clinical trial design and conduct through patient and public involvement and engagement (PPIE) in regulatory science and healthcare regulation 50–52,69 . To our knowledge, this is the first report of such an interactive, moderated discussion of caregiver perspectives on these aspects.…”

Section: Discussionsupporting

confidence: 64%

“…This is also in line with increasing efforts from regulatory agencies worldwide to ensure that the patient voice remains central to clinical trial design and conduct through patient and public involvement and engagement (PPIE) in regulatory science and healthcare regulation. [50][51][52]69 To our knowledge, this is the first report of such an interactive, moderated discussion of caregiver perspectives on these aspects. The virtual platform, available 24/7 for a 2week period, enabled the inclusion of diverse perspectives from caregivers across geographies, which may not have been feasible with a traditional, in-person format, particularly as this information was collected during the COVID-19 pandemic.…”

Section: Discussionmentioning

confidence: 99%

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Amblyopia—A novel virtual round table to explore the caregiver perspective

Nowik

Perna

Dahlmann‐Noor

et al. 2023

Ophthalmic Physiologic Optic

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PurposeA survey aimed to capture the caregiver's perspective on the impact of amblyopia and its treatment on the child and family, as well as caregivers' views on the design and feasibility of clinical trials investigating dichoptic binocular therapies for amblyopia.MethodsParents of amblyopic children, patient advocates and healthcare professionals took part in a moderated, structured discussion on a novel virtual advisory‐board platform.ResultsSeven parents of children with amblyopia, two patient organisation representatives, one ophthalmologist and one optometrist participated in the survey. A total of 645 posts were entered on the platform over a 14‐day period in September 2021. There was widespread agreement that the management of amblyopia poses more of a burden on the child and family than the condition itself, with treatment burden accentuated when treatment is unsuccessful. Parents expressed uncertainty and frustration in relation to the duration of patching, success of patching and alternative treatment options, and felt there was inadequate readily available, easy‐to‐understand information on the condition. Parents reported that a new treatment for amblyopia, such as dichoptic binocular therapy using video games, should be safe, non‐invasive and engaging compared with an eye patch. Treating at home, potentially for a shorter treatment duration, and with an entertaining game were the main reasons parents would join a clinical study with this type of novel therapy. However, due to a limited critical period treatment window, parents would feel more comfortable joining a clinical trial if traditional therapies were offered in conjunction with those under investigation.ConclusionPatient perspectives and the role of caregivers in the acceptance of any interventional treatments are increasingly recognised. Understanding how amblyopia and its treatment impacts a child and family should be an important premise to guide therapy and evaluate treatment value, both in clinical trials and in routine medical practice.

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Section: Discussionsupporting

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Amblyopia—A novel virtual round table to explore the caregiver perspective

Nowik

Perna

Dahlmann‐Noor

et al. 2023

Ophthalmic Physiologic Optic

View full text Add to dashboard Cite

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Considerations for patient and public involvement and engagement in health research

Aiyegbusi

McMullan

Hughes

et al. 2023

Nat Med

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Patient and Public Involvement in Research: Lessons for Inflammatory Bowel Disease

Honap

Buisson

Danese

et al. 2023

Journal of Crohn's and Colitis

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Participatory research, also referred to as patient and public involvement, is an approach that involves collaborating with patients affected by the focus of the research, on the design, development, and delivery of research to improve outcomes. There are two broad justifications for this; firstly, that it enhances the quality and relevance of research, and secondly, that it satisfies the ethical argument of patient inclusion for decisions about them. This synergistic and collaborative effort, which bridges the divide between researchers and participants with the lived condition, is now a mainstream activity and widely accepted as best practice. Although there has been a substantial increase in the literature over the past two decades, little has been published on how participatory research has been used in inflammatory bowel disease research and little guidance as to how researchers should go about this. With an increasing incidence and prevalence worldwide, combined with declining study enrolment in an era of perennial unmet need, there are a multitude of benefits of participatory research to IBD patients and investigators, including research output that is informed and relevant to the real world. A key example of participatory research in IBD is the I-CARE study, a large-scale, pan-European observational study assessing the safety of advanced therapies, which had significant patient involvement throughout the study. In this review, we provide a comprehensive overview of the benefits and challenges of participatory research and discuss opportunities of building strategic alliances between IBD patients, healthcare providers, and academics to strengthen research outcomes.

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The opportunity for greater patient and public involvement and engagement in drug development and regulation

Cited by 3 publications

References 3 publications

Amblyopia—A novel virtual round table to explore the caregiver perspective

Amblyopia—A novel virtual round table to explore the caregiver perspective

Considerations for patient and public involvement and engagement in health research

Patient and Public Involvement in Research: Lessons for Inflammatory Bowel Disease

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