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Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis
OBJECTIVE: To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy. DESIGN: Qualitative analysis. DATA SOURCES: Cli...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group Ltd.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9186156/ https://www.ncbi.nlm.nih.gov/pubmed/35688481 http://dx.doi.org/10.1136/bmj-2021-067745 |
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author | Williams, Rebecca J Dobbins, Heather D Tse, Tony Chon, Sandy D Loose, David Sarosy, Gisele A Prindiville, Sheila A Rockhold, Frank W Zarin, Deborah A |
author_facet | Williams, Rebecca J Dobbins, Heather D Tse, Tony Chon, Sandy D Loose, David Sarosy, Gisele A Prindiville, Sheila A Rockhold, Frank W Zarin, Deborah A |
author_sort | Williams, Rebecca J |
collection | PubMed |
description | OBJECTIVE: To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy. DESIGN: Qualitative analysis. DATA SOURCES: ClinicalTrials.gov trial registry. MAIN OUTCOME MEASURES: Established goals and related practices of the trial reporting system were outlined, examples and key characteristics of MPRPs were reviewed, and specific challenges in registering and reporting summary results to databases designed for traditional clinical trial designs that rely on a model of one study per protocol were identified. RESULTS: A reporting approach is proposed that accommodates the complex study design of MPRPs and their results. This approach involves the use of separate registration records for each substudy within one MPRP protocol (with potential exceptions noted). CONCLUSIONS: How the proposed approach allows for clear, descriptive, structured information about each substudy’s prespecified design and supports timely reporting of results after completion of each substudy is described and illustrated. Although the focus is on reporting to ClinicalTrials.gov, the approach supports broader application across trial registries and results databases. This paper is intended to stimulate further discussion of this approach among stakeholders, build awareness about the need to improve reporting of MPRPs, and encourage harmonization across trial registries globally. |
format | Online Article Text |
id | pubmed-9186156 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-91861562022-06-16 Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis Williams, Rebecca J Dobbins, Heather D Tse, Tony Chon, Sandy D Loose, David Sarosy, Gisele A Prindiville, Sheila A Rockhold, Frank W Zarin, Deborah A BMJ Research OBJECTIVE: To describe an approach for reporting master protocol research programs (MPRPs) that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy. DESIGN: Qualitative analysis. DATA SOURCES: ClinicalTrials.gov trial registry. MAIN OUTCOME MEASURES: Established goals and related practices of the trial reporting system were outlined, examples and key characteristics of MPRPs were reviewed, and specific challenges in registering and reporting summary results to databases designed for traditional clinical trial designs that rely on a model of one study per protocol were identified. RESULTS: A reporting approach is proposed that accommodates the complex study design of MPRPs and their results. This approach involves the use of separate registration records for each substudy within one MPRP protocol (with potential exceptions noted). CONCLUSIONS: How the proposed approach allows for clear, descriptive, structured information about each substudy’s prespecified design and supports timely reporting of results after completion of each substudy is described and illustrated. Although the focus is on reporting to ClinicalTrials.gov, the approach supports broader application across trial registries and results databases. This paper is intended to stimulate further discussion of this approach among stakeholders, build awareness about the need to improve reporting of MPRPs, and encourage harmonization across trial registries globally. BMJ Publishing Group Ltd. 2022-06-10 /pmc/articles/PMC9186156/ /pubmed/35688481 http://dx.doi.org/10.1136/bmj-2021-067745 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Research Williams, Rebecca J Dobbins, Heather D Tse, Tony Chon, Sandy D Loose, David Sarosy, Gisele A Prindiville, Sheila A Rockhold, Frank W Zarin, Deborah A Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis |
title | Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis |
title_full | Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis |
title_fullStr | Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis |
title_full_unstemmed | Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis |
title_short | Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis |
title_sort | approach for reporting master protocol study designs on clinicaltrials.gov: qualitative analysis |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9186156/ https://www.ncbi.nlm.nih.gov/pubmed/35688481 http://dx.doi.org/10.1136/bmj-2021-067745 |
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