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14 results for “trial results reporting”
Data from: Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
Objectives: To develop and pilot a tool to measure and improve pharmaceutical companies' clinical trial data sharing policies and practices. Design: Cross sectional descriptive analysis. Setting: Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015. Data sources: Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies. Main outcome measures: Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve company data sharing policies and practices. Results: Only 25% of large pharmaceutical companies fully met the data sharing measure. The median company data sharing score was 63% (interquartile range 58-85%). Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33% and the median company data sharing score to 80% (73-100%). The most common reasons companies did not initially satisfy the data sharing measure were failure to share data by the specified deadline (75%) and failure to report the number and outcome of their data requests. Across new drug applications, a median of 100% (interquartile range 91-100%) of trials in patients were registered, 65% (36-96%) reported results, 45% (30-84%) were published, and 95% (69-100%) were publicly available in some form by six months after FDA drug approval. When examining results on the drug level, less than half (42%) of reviewed drugs had results for all their new drug applications trials in patients publicly available in some form by six months after FDA approval. Conclusions: It was feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Among large companies, 25% made participant level trial data accessible to external investigators for new drug approvals in accordance with the current study's measures; this proportion improved to 33% after applying the ranking tool. Other measures of trial transparency were higher. Some companies, however, have substantial room for improvement on transparency and data sharing of clinical trials.
Data from: Trial-results reporting and academic medical centers.
To the Editor: Reporting of aggregate results helps mitigate disclosure biases affecting medical research. Although the reporting of summary results is currently mandated by the Food and Drug Administration Amendments Act of 2007 (FDAAA), published findings suggest underreporting. Two recent proposals are aimed at improving public reporting of aggregate results. These are a Notice of Proposed Rulemaking (NPRM) to expand FDAAA requirements to include the results of trials of unapproved products, and a draft policy requiring the results of all National Institutes of Health (NIH)-funded trials, including those not subject to the FDAAA.
Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by English-speaking Patients
ClinicalTrials.gov study NCT03095586. IPD Sharing: NO. Countries: 1. Publications: 1.
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population
ClinicalTrials.gov study NCT03094104. IPD Sharing: NO. Countries: 1. Publications: 1.
Data from: Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study
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Data from: Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
Open the record for dataset details and reuse information.
Data from: Trial-results reporting and academic medical centers.
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Data from: Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers
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Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by English-speaking Population
ClinicalTrials.gov study NCT03095911. IPD Sharing: NO. Countries: 1. Publications: 0.
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by French-speaking Population
ClinicalTrials.gov study NCT03094130. IPD Sharing: NO. Countries: 1. Publications: 0.
Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by French-speaking Population
ClinicalTrials.gov study NCT03095950. IPD Sharing: NO. Countries: 1. Publications: 0.
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by English-speaking Population*
ClinicalTrials.gov study NCT03094091. IPD Sharing: NO. Countries: 1. Publications: 0.
Interpretation of Health News Items Reporting Results of Randomized Controlled Trials With or Without Spin by French-speaking Patients
ClinicalTrials.gov study NCT03095924. IPD Sharing: NO. Countries: 1. Publications: 0.
Interpretation of Health News Items Reporting Results of Phase I/II (Non-randomized) Trials With or Without Spin by French-speaking Patients
ClinicalTrials.gov study NCT03094117. IPD Sharing: NO. Countries: 1. Publications: 0.
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