A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved]
Background: Public Health Emergencies (PHE) demand expeditious research responses to evaluate new or repurposed therapies and prevention strategies. Alternative Design Trials (ADTs) and Adaptive Platform Trials (APTs) have enabled efficient large-scale testing of biomedical interventions during rece...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wellcome
2023-05-01
|
| Series: | Wellcome Open Research |
| Subjects: | |
| Online Access: | https://wellcomeopenresearch.org/articles/8-194/v1 |
| _version_ | 1797733171819708416 |
|---|---|
| author | Phaik Yeong Cheah Ilja Ormel Alun Davies Nina Gobat Alexe Bernier Lisa Schwartz Eli Harriss Noni Mumba |
| author_facet | Phaik Yeong Cheah Ilja Ormel Alun Davies Nina Gobat Alexe Bernier Lisa Schwartz Eli Harriss Noni Mumba |
| author_sort | Phaik Yeong Cheah |
| collection | DOAJ |
| description | Background: Public Health Emergencies (PHE) demand expeditious research responses to evaluate new or repurposed therapies and prevention strategies. Alternative Design Trials (ADTs) and Adaptive Platform Trials (APTs) have enabled efficient large-scale testing of biomedical interventions during recent PHEs. Design features of these trials may have implications for engagement and/or informed consent processes. We aimed to rapidly review evidence on engagement and informed consent for ADTs and APTs during PHE to consider what (if any) recommendations can inform practice. Method: In 2022, we searched 8 prominent databases for relevant peer reviewed publications and guidelines for ADTs/APTs in PHE contexts. Articles were selected based on pre-identified inclusion and exclusion criteria. We reviewed protocols and informed consent documents for a sample of large platform trials and consulted with key informants from ADTs/APT trial teams. Data were extracted and summarised using narrative synthesis. Results: Of the 49 articles included, 10 were guidance documents, 14 discussed engagement, 10 discussed informed consent, and 15 discussed both. Included articles addressed ADTs delivered during the West African Ebola epidemic and APTs delivered during COVID-19. PHE clinical research guidance documents highlight the value of ADTs/APTs and the importance of community engagement, but do not provide practice-specific guidance for engagement or informed consent. Engagement and consent practice for ADTs conducted during the West African Ebola epidemic have been well-documented. For COVID-19, engagement and consent practice was described for APTs primarily delivered in high income countries with well-developed health service structures. A key consideration is strong communication of the complexity of trial design in clear, accessible ways. Conclusion: We highlight key considerations for best practice in community engagement and informed consent relevant to ADTs and APTs for PHEs which may helpfully be included in future guidance. Protocol: The review protocol is published online at Prospero on 15/06/2022: registration number CRD42022334170. |
| first_indexed | 2024-03-12T12:25:16Z |
| format | Article |
| id | doaj.art-faf46d95ff81426e8c4e8b06ced532b6 |
| institution | Directory Open Access Journal |
| issn | 2398-502X |
| language | English |
| last_indexed | 2024-03-12T12:25:16Z |
| publishDate | 2023-05-01 |
| publisher | Wellcome |
| record_format | Article |
| series | Wellcome Open Research |
| spelling | doaj.art-faf46d95ff81426e8c4e8b06ced532b62023-08-30T01:00:01ZengWellcomeWellcome Open Research2398-502X2023-05-01821401A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved]Phaik Yeong Cheah0https://orcid.org/0000-0001-6327-3266Ilja Ormel1Alun Davies2https://orcid.org/0000-0001-7784-9000Nina Gobat3Alexe Bernier4https://orcid.org/0000-0003-1322-804XLisa Schwartz5Eli Harriss6Noni Mumba7https://orcid.org/0000-0002-3531-8823Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Salaya, Nakhon Pathom, ThailandFaculty of Health Sciences, Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, CanadaHealth Systems Collaborative, Nuffield Department of Medicine, University of Oxford, Oxford, England, UKNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England, UKFaculty of Social Sciences, School of Social Work, McMaster University, Hamilton, Ontario, CanadaFaculty of Health Sciences, Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, CanadaBodleian Health Care Libraries, University of Oxford, Oxford, England, UKThe KEMRI-Wellcome Trust Research Programme, Kilifi, 80108, KenyaBackground: Public Health Emergencies (PHE) demand expeditious research responses to evaluate new or repurposed therapies and prevention strategies. Alternative Design Trials (ADTs) and Adaptive Platform Trials (APTs) have enabled efficient large-scale testing of biomedical interventions during recent PHEs. Design features of these trials may have implications for engagement and/or informed consent processes. We aimed to rapidly review evidence on engagement and informed consent for ADTs and APTs during PHE to consider what (if any) recommendations can inform practice. Method: In 2022, we searched 8 prominent databases for relevant peer reviewed publications and guidelines for ADTs/APTs in PHE contexts. Articles were selected based on pre-identified inclusion and exclusion criteria. We reviewed protocols and informed consent documents for a sample of large platform trials and consulted with key informants from ADTs/APT trial teams. Data were extracted and summarised using narrative synthesis. Results: Of the 49 articles included, 10 were guidance documents, 14 discussed engagement, 10 discussed informed consent, and 15 discussed both. Included articles addressed ADTs delivered during the West African Ebola epidemic and APTs delivered during COVID-19. PHE clinical research guidance documents highlight the value of ADTs/APTs and the importance of community engagement, but do not provide practice-specific guidance for engagement or informed consent. Engagement and consent practice for ADTs conducted during the West African Ebola epidemic have been well-documented. For COVID-19, engagement and consent practice was described for APTs primarily delivered in high income countries with well-developed health service structures. A key consideration is strong communication of the complexity of trial design in clear, accessible ways. Conclusion: We highlight key considerations for best practice in community engagement and informed consent relevant to ADTs and APTs for PHEs which may helpfully be included in future guidance. Protocol: The review protocol is published online at Prospero on 15/06/2022: registration number CRD42022334170.https://wellcomeopenresearch.org/articles/8-194/v1Adaptive trial Engagement Pandemic COVID-19 Ebola Informed Consenteng |
| spellingShingle | Phaik Yeong Cheah Ilja Ormel Alun Davies Nina Gobat Alexe Bernier Lisa Schwartz Eli Harriss Noni Mumba A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved] Wellcome Open Research Adaptive trial Engagement Pandemic COVID-19 Ebola Informed Consent eng |
| title | A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved] |
| title_full | A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved] |
| title_fullStr | A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved] |
| title_full_unstemmed | A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved] |
| title_short | A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved] |
| title_sort | rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies version 1 peer review 2 approved |
| topic | Adaptive trial Engagement Pandemic COVID-19 Ebola Informed Consent eng |
| url | https://wellcomeopenresearch.org/articles/8-194/v1 |
| work_keys_str_mv | AT phaikyeongcheah arapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT iljaormel arapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT alundavies arapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT ninagobat arapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT alexebernier arapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT lisaschwartz arapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT eliharriss arapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT nonimumba arapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT phaikyeongcheah rapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT iljaormel rapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT alundavies rapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT ninagobat rapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT alexebernier rapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT lisaschwartz rapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT eliharriss rapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved AT nonimumba rapidreviewofcommunityengagementandinformedconsentprocessesforadaptiveplatformtrialsandalternativedesigntrialsforpublichealthemergenciesversion1peerreview2approved |