555 Design Lab Methodology Supports Innovation in Clinical Trials
OBJECTIVES/GOALS: Since 2017, we have used the Design Lab methodology to support investigators taking innovative approaches to clinical effectiveness trial design. To date we have held 12 Design Labs and this year we are creating a handbook that will support dissemination of this approach across the...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Cambridge University Press
2024-04-01
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| Series: | Journal of Clinical and Translational Science |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124004722/type/journal_article |
| _version_ | 1797226835372670976 |
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| author | Marisha E Palm Paul Beninger Denise Daudelin Noe Duenas Gigi Hirsch Kris Markman Ellaina Reed Ludovic Trinquart Mark Trusheim Lisa Welch Harry Selker |
| author_facet | Marisha E Palm Paul Beninger Denise Daudelin Noe Duenas Gigi Hirsch Kris Markman Ellaina Reed Ludovic Trinquart Mark Trusheim Lisa Welch Harry Selker |
| author_sort | Marisha E Palm |
| collection | DOAJ |
| description | OBJECTIVES/GOALS: Since 2017, we have used the Design Lab methodology to support investigators taking innovative approaches to clinical effectiveness trial design. To date we have held 12 Design Labs and this year we are creating a handbook that will support dissemination of this approach across the Clinical and Translational Science Award consortium. METHODS/STUDY POPULATION: The Clinical Trial Design Lab brings together a multi-stakeholder group to consider innovative and impactful clinical trial designs. An investigative team is selected from a competitive pool of applicants, after which expert-led consultations support the investigator team to think about evidence generation in the context of the full treatment development pathway. Teams map the stakeholders at each step of this pathway (e.g. clinicians, patients, researchers, funders, industry experts, policy experts, regulatory experts, payers) and consider innovative design solutions. These consultations prepare investigators for an event that involves all stakeholders in a structured and facilitated discussion about trial designs that generate the best evidence and increase potential for health impact. RESULTS/ANTICIPATED RESULTS: The result of our work will be a set of Design Lab principles, a handbook with templates that support stakeholder mapping and structured discussions, and educational resources to accompany the handbook. The work is supported by a literature review that characterizes the multi-component processes included in the Design Lab, situates them within the larger context of team science interventions, and lays groundwork for the development of process metrics and impact evaluation criteria to assess the Design Lab method. In this poster presentation, we will share our multi-component broadly engaged team science approach, provide a brief outline of the principles and educational resources, and include an early version of the evaluation criteria. DISCUSSION/SIGNIFICANCE: Broadly engaged team science supports innovative thinking about study design and is especially important in the development of clinical trials. We have grown the Design Lab program of work over the past seven years and are now able to characterize our team science methodology and support others to use this approach to innovate for health impact. |
| first_indexed | 2024-04-24T14:31:13Z |
| format | Article |
| id | doaj.art-832f1164c54c451fb5a0714092dc49ba |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-24T14:31:13Z |
| publishDate | 2024-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-832f1164c54c451fb5a0714092dc49ba2024-04-03T02:00:34ZengCambridge University PressJournal of Clinical and Translational Science2059-86612024-04-01816516510.1017/cts.2024.472555 Design Lab Methodology Supports Innovation in Clinical TrialsMarisha E Palm0Paul Beninger1Denise Daudelin2Noe Duenas3Gigi Hirsch4Kris Markman5Ellaina Reed6Ludovic Trinquart7Mark Trusheim8Lisa Welch9Harry Selker10Tufts UniversityTufts UniversityTufts UniversityTufts UniversityTufts UniversityTufts UniversityTufts UniversityTufts UniversityTufts UniversityTufts UniversityTufts UniversityOBJECTIVES/GOALS: Since 2017, we have used the Design Lab methodology to support investigators taking innovative approaches to clinical effectiveness trial design. To date we have held 12 Design Labs and this year we are creating a handbook that will support dissemination of this approach across the Clinical and Translational Science Award consortium. METHODS/STUDY POPULATION: The Clinical Trial Design Lab brings together a multi-stakeholder group to consider innovative and impactful clinical trial designs. An investigative team is selected from a competitive pool of applicants, after which expert-led consultations support the investigator team to think about evidence generation in the context of the full treatment development pathway. Teams map the stakeholders at each step of this pathway (e.g. clinicians, patients, researchers, funders, industry experts, policy experts, regulatory experts, payers) and consider innovative design solutions. These consultations prepare investigators for an event that involves all stakeholders in a structured and facilitated discussion about trial designs that generate the best evidence and increase potential for health impact. RESULTS/ANTICIPATED RESULTS: The result of our work will be a set of Design Lab principles, a handbook with templates that support stakeholder mapping and structured discussions, and educational resources to accompany the handbook. The work is supported by a literature review that characterizes the multi-component processes included in the Design Lab, situates them within the larger context of team science interventions, and lays groundwork for the development of process metrics and impact evaluation criteria to assess the Design Lab method. In this poster presentation, we will share our multi-component broadly engaged team science approach, provide a brief outline of the principles and educational resources, and include an early version of the evaluation criteria. DISCUSSION/SIGNIFICANCE: Broadly engaged team science supports innovative thinking about study design and is especially important in the development of clinical trials. We have grown the Design Lab program of work over the past seven years and are now able to characterize our team science methodology and support others to use this approach to innovate for health impact.https://www.cambridge.org/core/product/identifier/S2059866124004722/type/journal_article |
| spellingShingle | Marisha E Palm Paul Beninger Denise Daudelin Noe Duenas Gigi Hirsch Kris Markman Ellaina Reed Ludovic Trinquart Mark Trusheim Lisa Welch Harry Selker 555 Design Lab Methodology Supports Innovation in Clinical Trials Journal of Clinical and Translational Science |
| title | 555 Design Lab Methodology Supports Innovation in Clinical Trials |
| title_full | 555 Design Lab Methodology Supports Innovation in Clinical Trials |
| title_fullStr | 555 Design Lab Methodology Supports Innovation in Clinical Trials |
| title_full_unstemmed | 555 Design Lab Methodology Supports Innovation in Clinical Trials |
| title_short | 555 Design Lab Methodology Supports Innovation in Clinical Trials |
| title_sort | 555 design lab methodology supports innovation in clinical trials |
| url | https://www.cambridge.org/core/product/identifier/S2059866124004722/type/journal_article |
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