Dataset Information

Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States.

ABSTRACT: OBJECTIVE:To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies. DESIGN:We performed a reassessment of the data reported in Miller et al to evaluate whether statutory compliance analyses and conclusions were valid. DATA SOURCES:Information from the Dryad Digital Repository, ClinicalTrials.gov, Drugs@FDA and direct communications with sponsors. MAIN OUTCOME MEASURES:Compliance with the clinical trial registration and results reporting requirements under the Food and Drug Administration Amendments Act (FDAAA). RESULTS:Industry compliance with FDAAA disclosure requirements was notably higher than reported by Miller et al. Among trials subject to FDAAA, Miller et al reported that, per drug, a median of 67% (middle 50% range: 0%-100%) of trials fully complied with registration and results reporting requirements. On reanalysis of the data, we found that a median of 100% (middle 50% range: 93%-100%) of clinical trials for a particular drug fully complied with the law. When looking at overall compliance at the trial level, our reassessment yields 94% timely registration and 90% timely results reporting among the 49 eligible trials, and an overall FDAAA compliance rate of 86%. CONCLUSIONS:The claim by Miller et al that industry compliance is below legal standards is based on an analysis that relies on an incomplete dataset and an interpretation of FDAAA that requires disclosure of study results for drugs that have not yet been approved for any indication. On reanalysis using a different interpretation of FDAAA that focuses on whether results were disclosed within 30 days of drug approval, we found that industry compliance with US statutory disclosure requirements for the 15 reviewed drugs was consistently high.

SUBMITTER: Lassman SM

PROVIDER: S-EPMC5623439 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States.

Lassman Scott M SM Shopshear Olivia M OM Jazic Ina I Ulrich Jocelyn J Francer Jeffrey J

BMJ open 20170923 9

<h4>Objective</h4>To evaluate the accuracy of a 2015 cross-sectional analysis published in the <i>BMJ Open</i> which reported that pharmaceutical industry compliance with clinical trial registration and results reporting requirements under US law was suboptimal and varied widely among companies.<h4>Design</h4>We performed a reassessment of the data reported in Miller <i>et al</i> to evaluate whether statutory compliance analyses and conclusions were valid.<h4>Data sources</h4>Information from th ...[more]

PMID: 28942418

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Project description:BackgroundMany clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations.MethodsWe conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis.ResultsEligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and social desirability, this could be a "best case" scenario.ConclusionsBefore the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.

Project description:BackgroundConfidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.MethodsEligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration.ResultsOf 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709).ConclusionsThe quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed.

Project description:Objective: Clinical trials are the source of evidence. ClinicalTrials.gov is valuable for analyzing current conditions. Until now, the state of drug interventions for heart infections is unknown. The purpose of this study was to comprehensively assess the characteristics of trials on cardiac-related infections and the status of drug interventions. Methods: The website ClinicalTrials.gov was used to obtain all registered clinical trials on drug interventions for cardiac-related infections as of February 16, 2019. All registration studies were collected, regardless of their recruitment status, research results, and research type. Registration information, results, and weblink-publications of those trials were analyzed. Results: A total of 45 eligible trials were evaluated and 86.7% of them began from or after 2008 while 91.1% of them adopted interventional study design. Of all trials, 35.6% were completed and 15.6% terminated. Besides, 62.2% of interventional clinical trials recruited more than 100 subjects. Meanwhile, 86.7% of the eligible trials included adult subjects only. Of intervention trials, 65.8% were in the third or fourth phase; 78.1% adopted randomized parallel assignment, containing two groups; 53.6% were masking, and 61.0% described treatment. Moreover, 41.5% of the trials were conducted in North America while 29.3% in Europe. Sponsors for 40.0% of the studies were from the industry. Furthermore, 48.9% of the trials mentioned information on monitoring committees, 24.4% have been published online, and 13.3% have uploaded their results. Drugs for treatments mainly contained antibiotics, among which glycopeptides, β-lactams, and lipopeptides were the most commonly studied ones in experimental group, with the former ones more common. Additionally, 16.2% of the trials evaluated new antimicrobials. Conclusions: Most clinical trials on cardiac-related infections registered at ClinicalTrials.gov were interventional randomized controlled trials (RCTs) for treatment. Most drugs focused in trials were old antibiotics, and few trials reported valid results. It is necessary to strengthen supervision over improvements in results, and to combine antibacterial activity with drug delivery regimens to achieve optimal clinical outcomes.

Project description:ObjectiveProspective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported transparently in journal publications and investigated factors associated with transparent reporting.DesignWe used a dataset of trials registered in ClinicalTrials.gov or Deutsches Register Klinischer Studien, with a German University Medical Center as the lead centre, completed in 2009-2017, and with a corresponding peer-reviewed results publication. We extracted all registration statements from results publications of retrospectively registered trials and assessed whether they mention or justify the retrospective registration. We analysed associations of retrospective registration and reporting thereof with registration number reporting, International Committee of Medical Journal Editors (ICMJE) membership/-following and industry sponsorship using χ2 or Fisher exact test.ResultsIn the dataset of 1927 trials with a corresponding results publication, 956 (53.7%) were retrospectively registered. Of those, 2.2% (21) explicitly report the retrospective registration in the abstract and 3.5% (33) in the full text. In 2.1% (20) of publications, authors provide an explanation for the retrospective registration in the full text. Registration numbers were significantly underreported in abstracts of retrospectively registered trials compared with prospectively registered trials. Publications in ICMJE member journals did not have statistically significantly higher rates of both prospective registration and disclosure of retrospective registration, and publications in journals claiming to follow ICMJE recommendations showed statistically significantly lower rates compared with non-ICMJE-following journals. Industry sponsorship of trials was significantly associated with higher rates of prospective registration, but not with transparent registration reporting.ConclusionsContrary to ICMJE guidance, retrospective registration is disclosed and explained only in a small number of retrospectively registered studies. Disclosure of the retrospective nature of the registration would require a brief statement in the manuscript and could be easily implemented by journals.

Dataset Information

Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States.

Publications

Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States.

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