Dataset Information

Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

ABSTRACT:

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.

SUBMITTER: Williams RJ

PROVIDER: S-EPMC9186156 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

Williams Rebecca J RJ Dobbins Heather D HD Tse Tony T Chon Sandy D SD Loose David D Sarosy Gisele A GA Prindiville Sheila A SA Rockhold Frank W FW Zarin Deborah A DA

BMJ (Clinical research ed.) 20220610

<h4>Objective</h4>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.<h4>Design</h4>Qualitative analysis.<h4>Data sources</h4>ClinicalTrials.gov trial registry.<h4>Main outcome measures</h4>Established goals and related practices of the trial reporting system were outlined, examples and key characteristics of ...[more]

PMID: 35688481

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Project description:BackgroundThe Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.MethodsUsing an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period.ResultsFrom all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.ConclusionsDespite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).

Project description:Aim: To evaluate the completeness of the description of nonsurgical periodontal therapy interventions in clinical trials registered in ClinicalTrials.gov and correspondence of registered information for trial participants and outcome measures with published articles. Materials & methods: We retrieved data from ClinicalTrials.gov and corresponding publications. The completeness of intervention reporting was assessed using the Template for Intervention Description and Replication (TIDieR) checklist for oral hygiene instructions (OHI), professional mechanical plaque removal (PMPR), and subgingival instrumentation, antiseptics and antibiotics. The completeness of registration of trial protocol information was assessed according to the WHO Trial Registration DataSet for participant information (enrollment, sample size calculation, age, gender, condition) and primary/secondary outcome measures. Results: 79 included trials involved OHI (n = 38 trials, 48.1%), PMPR (n = 19, 24.1%), antiseptics (n = 11, 12.7%), or antibiotics (n = 11, 12.7%). There was a great variety in the terms used to describe these interventions. Most of the analyzed trials (93.7%) were completed and did not provide any data on study phase (74.7%). The description of intervention in the registry in ClinicalTrials.gov was inadequate for all analyzed interventions, with description inconsistencies in matching publications. There were also discrepancies in registered and published outcomes: for 39 trials with published results, 18 had different registered and reported primary outcomes, and 29 different registered and reported secondary outcomes. Conclusion: The completeness of the description of nonsurgical therapy of periodontitis in clinical trials is unsatisfactory, reducing the quality of translation of the new evidence and procedures into clinical practice. Significant discrepancy in registered and reported trial outcomes calls into question the validity of reported results and relevance for practice.

Project description:Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0.51-0.83)). Conclusion A total of 15% of pulmonary clinical highly likely applicable clinical trials report basic summary results to ClinicalTrials.gov within 1 year of trial completion. Strategies to improve reporting are needed within the pulmonary community.

Dataset Information

Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

Objective

Design

Data sources

Main outcome measures

Results

Conclusions

Publications

Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.

Similar Datasets

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