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Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

ABSTRACT: ClinicalTrials.gov requires reporting of result summaries for many drug and device trials.To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature.ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases.10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups.One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication.Small sample that included earliest results posted to the database.Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication.Agency for Healthcare Research and Quality.

SUBMITTER: Hartung DM

PROVIDER: S-EPMC4617780 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

Hartung Daniel M DM Zarin Deborah A DA Guise Jeanne-Marie JM McDonagh Marian M Paynter Robin R Helfand Mark M

Annals of internal medicine 20140401 7

<h4>Background</h4>ClinicalTrials.gov requires reporting of result summaries for many drug and device trials.<h4>Purpose</h4>To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature.<h4>Data sources</h4>ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases.<h4>Study selection</h4>10% random sample of phase 3 or 4 trial ...[more]

PMID: 24687070

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Project description:ImportanceClinical trial registries are intended to increase clinical research transparency by nonselectively identifying and documenting clinical trial designs and outcomes. Inconsistencies in reported data undermine the utility of such registries and have previously been noted in general medical literature.ObjectiveTo assess whether inconsistencies in reported data exist between ophthalmic literature and clinical trial registries.Design, setting, and participantsIn this retrospective, cross-sectional study, interventional clinical trials published from January 1, 2014, to December 31, 2014, in the American Journal of Ophthalmology, JAMA Ophthalmology, and Ophthalmology were reviewed. Observational, retrospective, uncontrolled, and post hoc reports were excluded, yielding a sample size of 106 articles. Data collection was performed from January through September 2016. Data review and adjudication continued through January 2017.Main outcomes and measuresIf possible, articles were matched to registry entries listed in the ClinicalTrials.gov database or in 1 of 16 international registries indexed by the World Health Organization International Clinical Trials Registry Platform version 3.2 search engine. Each article-registry pair was assessed for inconsistencies in design, results, and funding (each of which was further divided into subcategories) by 2 reviewers and adjudicated by a third.ResultsOf 106 trials that met the study criteria, matching registry entries were found for 68 (64.2%), whereas no matching registry entries were found for 38 (35.8%). Inconsistencies were identified in study design, study results, and funding sources, including specific interventions in 8 (11.8%), primary outcome measure (POM) designs in 32 (47.1%), and POM results in 48 (70.6%). In addition, numerous data pieces were unreported, including analysis methods in 52 (76.5%) and POM results in 38 (55.9%).Conclusions and relevanceClinical trial registries were underused in this sample of ophthalmology clinical trials. For studies with registry data, inconsistency rates between published and registered data were similar to those previously reported for general medical literature. In most cases, inconsistencies involved missing data, but explicit discrepancies in methods and/or data were also found. Transparency and credibility of published trials may be improved by closer attention to their registration and reporting.

Project description:ImportanceOphthalmology-residency selection committees require robust metrics to review applicants. Participation in research activities is a core component of the application process for its perceived association with future academic productivity.ObjectiveTo evaluate the correlation between the number of preresidency peer-reviewed publications (PPPs) and subsequent peer-reviewed publications or career choices of ophthalmology residency graduates.Design, setting, and participantsIn this cross-sectional study, names of ophthalmology residency graduates were obtained. PubMed-indexed publication records were generated and publications were categorized as preresidency, intraresidency, and postresidency. First author and journal publications with an impact factor (IF) score of 3 or more were recorded. Current academic and community-based career statuses were designated. Names were obtained from cohort and alumni lists on residency program websites or by emailing program directors. Participants included US Accreditation Council for Graduate Medical Education-accredited ophthalmology residency graduates from 2013 to 2016.Main outcomes and measuresThe primary outcome measure was association of PPPs with later publications, first authorship, and journal publications with an IF score of 3 or more. The secondary outcome measure was difference in characteristics associated with academic vs community-based ophthalmologist.ResultsA total of 964 ophthalmologists (52% of graduates) were studied and most (85.5%) had PubMed-indexed publications. First authorship (ρ = 0.71; 95% CI, 0.67-0.74; P < .001) had a strong positive correlation with intraresidency publications, while journal publications with an IF score of 3 or more (ρ = 0.56; 95% CI, 0.51-0.60; P < .001) and PPPs (ρ = 0.38; 95% CI, 0.32-0.43; P < .001) had moderate and weak positive correlations, respectively. For postresidency publications, journal publications with an IF score of 3 or more (ρ = 0.86; 95% CI, 0.84-0.87; P < .001) had the strongest positive correlation followed by first authorship (ρ = 0.77; 95% CI, 0.74-0.79; P < .001) and PPPs (ρ = 0.26; 95% CI, 0.20-0.31; P < .001). Preresidency (t = 3.3; P = .001), intraresidency (t = 4.1; P < .001), postresidency (t = 7.5; P < .001), first author (t = 6.6; P < .001), and journal publications with an IF score of 3 or more (t = 5.9; P < .001) were greater for academic ophthalmologists compared with community-based ophthalmologists.Conclusions and relevancePreresidency publication history is at least weakly correlated with future publications or work in an academic setting among ophthalmologists. Multiple factors associated with academic productivity were evaluated; however, adjustment for multiple analyses was not done and further testing is required to prove whether these factors are predictive.

Project description:The 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.Using 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.From 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.Despite 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:BackgroundThere are increasing calls for patient involvement in sharing health research results, but no evidence-based recommendations to guide such involvement. Our objectives were to: (1) conduct a systematic review of the evidence on patient involvement in results sharing, (2) propose evidence-based recommendations to help maximize benefits and minimize risks of such involvement and (3) conduct this project with patient authors.MethodsTo avoid research waste, we verified that no systematic reviews were registered or published on this topic. We co-created, with patients, a PRISMA-P-compliant protocol. We included peer-reviewed publications reporting the effects of patient involvement in preparing peer-reviewed publications or results summaries from health research studies. We searched (9/10/2017) MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews, and secondary information sources (until 11/06/2018). We assessed the risk of bias in eligible publications and extracted data using standardized processes. To evaluate patient involvement in this project, we co-created a Patient Authorship Experience Tool.ResultsAll nine eligible publications reported on patient involvement in preparing publications; none on preparing results summaries. Evidence quality was moderate. A qualitative synthesis of evidence indicated the benefits of patient involvement may outweigh the risks. We have proposed 21 evidence-based recommendations to help maximize the benefits and minimize the risks when involving patients as authors of peer-reviewed publications. The recommendations focus on practical actions patient and non-patient authors can take before (10 recommendations), during (7 recommendations) and after (4 recommendations) manuscript development. Using the Patient Authorship Experience Tool, both patient and non-patient authors rated their experience highly.ConclusionsBased on a systematic review, we have proposed 21 evidence-based recommendations to help maximize the benefits and minimize the risks of involving patients as authors of peer-reviewed publications.

Project description:Study Design: Scoping review Objective: To study the design, clinical setting and outcome measures used in spinal cord injury rehabilitation publications. Methods: A literature search on PubMed and Medline was conducted focusing on articles published between 1990-2016 and using "traumatic SCI", "functional outcomes", "rehabilitation", "work" and "return to work" as outcomes. Studies were categorized based on design (intervention, including RCTs vs. non-intervention studies), settings (inpatient vs. outpatient vs. transition), and outcome measures used (impairment vs. function vs. participation/integration vs. quality of life vs. symptoms). Work-related studies were categorized independently. Results: Five hundred forty-four articles met the inclusion criteria. Of these, 234 were interventional studies, including 23 RCTs. Studies were evenly divided among inpatient, outpatient and transition settings. Of the 234 interventional studies, 143 used functional evaluations. Sixty-one different functional instruments were used, with a predominant use of the Functional Independence Measure (61 times) and an additional use of SCI-specific measures, i.e. Spinal Cord Independence Measure and Craig Handicap Assessment and Reporting Technique (13 times each). Fifty-one studies measured mobility, while only three measured hand functions. The work-related sub-analysis revealed 32 intervention studies (no RCTs), of which 15 used functional evaluations and only three focused on tetraplegia. Conclusion: Our study revealed a paucity of intervention trials and RCTs, indicating a dearth of knowledge that would be needed to establish evidence-based practice guidelines. This is particularly true for tetraplegia. While standard measures of function were frequently used, providing valuable data, there is no consensus about what exact outcome measure to use. Using newer measurement techniques, for instance based on the application of item response theory, should be considered to enhance uniformity.

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Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

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Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

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