scholarly journals Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Zahra Jamal ◽  
◽  
Alexander Perkins ◽  
Christopher Allen ◽  
Richard Evans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Ethics ◽  
Public Involvement ◽  
Ethics Committees ◽  
Patient And Public Involvement ◽  
Research Ethics Committees ◽  
The Public ◽  
Clinical Trials Unit ◽  
The Uk

Plain English summary Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Abstract Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.

scholarly journals Registration audit of clinical trials given a favourable opinion by UK research ethics committees

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e026840 ◽  
Author(s):  
Carla Denneny ◽  
Sue Bourne ◽  
Simon E Kolstoe
Keyword(s):  
Clinical Trials ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethics Committee ◽  
Trial Registration ◽  
Research Ethics Committees ◽  
The European Union ◽  
Clinical Trial Registration ◽  
Research Ethics Committee ◽  
The Uk

ObjectiveTo determine levels of public registration for a cohort of clinical trials reviewed and given a favourable opinion by research ethics committees in the United Kingdom.Study designAudit of records.SettingClinical trials receiving a favourable ethics opinion between 1 January 2016 and 30 June 2016.Main outcome measuresCorrelation between trials on the UK research ethics committee database and any primary registry entry on the WHO International Clinical Trials Registry Platform or clinicaltrials.gov as of 29 August 2017 (14 to 20 months after the favourable ethics committee opinion).ResultsOver the study period 1014 trials received a favourable ethics opinion, with 397 (39%) registered on the European Union Drug Regulating Authorities Clinical Trials database, and 18 with an agreed clinical trial registration deferral. Excluding these trials, the total number subsequently requiring registration was 599, and of these 405 (40% of total) were found to be registered. Follow-up with the 194 investigators or sponsors of trials not found to be registered produced 121 responses with a further 10 (1%) trials having already registered, 55 commitments to register and a variety of other responses. The overall registration rate was therefore 80%.ConclusionsDespite researchers and sponsors being reminded that registration of clinical trials is a condition of the research ethics committee (REC) favourable opinion, one-fifth of clinical trials either had not been registered, or their registration could not easily be found, 14 to 20 months after receiving the favourable opinion letter. The methodology trialled here proved effective, and although there are positive indications of a culture change towards greater registration, our results show that more still needs to be done to increase trial registration.

scholarly journals ‘Give Us The Tools!’: development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046450
Author(s):  
Samantha Cruz Rivera ◽  
Richard Stephens ◽  
Rebecca Mercieca-Bebber ◽  
Ameeta Retzer ◽  
Claudia Rutherford ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Patient Reported Outcome ◽  
Flow Diagram ◽  
Additional Patient ◽  
The Public ◽  
Patient Reported ◽  
Trial Protocols ◽  
User Friendly

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

scholarly journals Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽  
2018 ◽  
pp. k4738 ◽  
Author(s):  
Joanna C Crocker ◽  
Ignacio Ricci-Cabello ◽  
Adwoa Parker ◽  
Jennifer A Hirst ◽  
Alan Chant ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Lived Experience ◽  
Odds Ratio ◽  
Public Involvement ◽  
Meta Analysis ◽  
Patient And Public Involvement ◽  
Retention Rates ◽  
The Impact

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

Should Research Ethics Committees Be Observing the Law or Working by Ethical Principles?

2005 ◽  
Vol 1 (1) ◽  
pp. 23-26 ◽  
Author(s):  
Charles Warlow
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Public Interest ◽  
Ethics Committees ◽  
Unintended Consequences ◽  
Research Ethics Committees ◽  
Individual Interest ◽  
The Public ◽  
The Law ◽  
The Individual

Recent laws, and their interpretation, have made clinical research more difficult to do, and sometimes impossible. Furthermore the results of that research which can be done may even be unreliable. This is certainly against the public interest, and indeed the individual patient interest as well. But ethics committees have to abide by the law and so even though it is surely unethical to work against the public and individual interest that is exactly what ethics committees now have to endorse. The unintended consequences of the new regulations must be reduced by amending the law.

scholarly journals Evaluation of a patient and public involvement training programme for researchers at a large biomedical research centre in the UK

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047995
Author(s):  
Rosamund Yu ◽  
Bec Hanley ◽  
Simon Denegri ◽  
Jaber Ahmed ◽  
Nicholas J McNally
Keyword(s):  
Biomedical Research ◽  
Public Involvement ◽  
Good Practice ◽  
Training Programme ◽  
Patient And Public Involvement ◽  
Research Centre ◽  
Major Research ◽  
The Public ◽  
The Uk ◽  
The Impact

ObjectivesTo design, deliver and evaluate a programme of training workshops for biomedical researchers aimed at building confidence and skills in actively involving patients and the public (PPI) in research.DesignA bespoke programme of training workshops in PPI aimed at researchers.SettingA large National Institute for Health Research Biomedical Research Centre in London and several partner organisations.Participants721 scientists, clinicians and research managers attending dedicated training in PPI at a major London NHS (National Health Service)–university partnership.InterventionsA programme of 72 training workshops, designed to build practical skills and confidence for researchers working with patients and the public in research, was delivered at a major research-active NHS:university partnership. An iterative approach was taken to the programme, with the content of the workshops continually reviewed and refreshed to respond to the needs of researchers. Surveys before, immediately following and 6 months after training investigated the impact on researchers’ confidence and skills in PPI work, and the kind of PPI they subsequently carried out.ResultsTraining brought about immediate marked increases in researchers’ self-reported confidence to carry out PPI activities within their research, and in their knowledge of good practice. The evaluation indicates that workshop attendees were more likely to involve patients in their research following training. Researchers tended to involve patients and the public in a range of areas, including input to study design and patient information, in particular.ConclusionsWhen positioned within a broader organisational strategy for PPI in research, such training has an important role to play in progressing PPI in a major research partnership. Training appeared to provide the confidence needed to carry out PPI which enabled further development of confidence and skills. Involving researchers who have attended the training in the ongoing development of the programme and bringing in patients to the training programme are key next steps.

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