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Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years
BACKGROUND: Pancreatic adenocarcinoma (PDAC) is a lethal cancer with few therapeutic options. Availability of results is a crucial step in interventional research. Our aim was to evaluate results availability for trials in patients with PDAC and explore associated factors. MATERIALS AND METHODS: We...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9632316/ https://www.ncbi.nlm.nih.gov/pubmed/35983949 http://dx.doi.org/10.1093/oncolo/oyac156 |
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author | Pellat, Anna Boutron, Isabelle Ravaud, Philippe |
author_facet | Pellat, Anna Boutron, Isabelle Ravaud, Philippe |
author_sort | Pellat, Anna |
collection | PubMed |
description | BACKGROUND: Pancreatic adenocarcinoma (PDAC) is a lethal cancer with few therapeutic options. Availability of results is a crucial step in interventional research. Our aim was to evaluate results availability for trials in patients with PDAC and explore associated factors. MATERIALS AND METHODS: We performed a retrospective cohort study and searched the ClinicalTrials.gov registry for trials evaluating PDAC management with a primary completion date between 1 January 2010 and 1 June 2020. Then, we searched for results submitted on ClinicalTrials.gov and/or published. Our primary outcome was the proportion of PDAC trials with available results: submitted on ClinicalTrials.gov (either publicly available or undergoing quality control check) and/or published in a full-text article. The association of predefined trial characteristics with results availability was assessed. RESULTS: We identified 551 trials of which 386 (70%) had available results. The cumulative percentage of trials with available results was 21% (95% CI, 18-25%) at 12 months after the primary completion date, 44% (95% CI, 30-48%) at 24 months and 57% (95% CI, 53-61%) at 36 months. Applicable clinical trials, required to comply with the 2007 Food and Drug Administration Amendments Act 801 and its final rule on reporting of results on ClinicalTrials.gov, were more likely to have available results over time (HR 2.1 [95% CI 1.72-2.63], P < .001). Industry-funded, small sample size, and terminated trials were less likely to have available results. Other trial characteristics showed no association with results availability. CONCLUSION: Our results highlight a waste in interventional research studying PDAC. |
format | Online Article Text |
id | pubmed-9632316 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-96323162022-11-04 Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years Pellat, Anna Boutron, Isabelle Ravaud, Philippe Oncologist Gastrointestinal Cancer BACKGROUND: Pancreatic adenocarcinoma (PDAC) is a lethal cancer with few therapeutic options. Availability of results is a crucial step in interventional research. Our aim was to evaluate results availability for trials in patients with PDAC and explore associated factors. MATERIALS AND METHODS: We performed a retrospective cohort study and searched the ClinicalTrials.gov registry for trials evaluating PDAC management with a primary completion date between 1 January 2010 and 1 June 2020. Then, we searched for results submitted on ClinicalTrials.gov and/or published. Our primary outcome was the proportion of PDAC trials with available results: submitted on ClinicalTrials.gov (either publicly available or undergoing quality control check) and/or published in a full-text article. The association of predefined trial characteristics with results availability was assessed. RESULTS: We identified 551 trials of which 386 (70%) had available results. The cumulative percentage of trials with available results was 21% (95% CI, 18-25%) at 12 months after the primary completion date, 44% (95% CI, 30-48%) at 24 months and 57% (95% CI, 53-61%) at 36 months. Applicable clinical trials, required to comply with the 2007 Food and Drug Administration Amendments Act 801 and its final rule on reporting of results on ClinicalTrials.gov, were more likely to have available results over time (HR 2.1 [95% CI 1.72-2.63], P < .001). Industry-funded, small sample size, and terminated trials were less likely to have available results. Other trial characteristics showed no association with results availability. CONCLUSION: Our results highlight a waste in interventional research studying PDAC. Oxford University Press 2022-08-19 /pmc/articles/PMC9632316/ /pubmed/35983949 http://dx.doi.org/10.1093/oncolo/oyac156 Text en © The Author(s) 2022. Published by Oxford University Press. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com. |
spellingShingle | Gastrointestinal Cancer Pellat, Anna Boutron, Isabelle Ravaud, Philippe Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years |
title | Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years |
title_full | Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years |
title_fullStr | Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years |
title_full_unstemmed | Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years |
title_short | Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years |
title_sort | availability of results of trials studying pancreatic adenocarcinoma over the past 10 years |
topic | Gastrointestinal Cancer |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9632316/ https://www.ncbi.nlm.nih.gov/pubmed/35983949 http://dx.doi.org/10.1093/oncolo/oyac156 |
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