Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission.
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ABSTRACT:
SUBMITTER: DeVito NJ
PROVIDER: S-EPMC8145152 | biostudies-literature | 2021 Aug
REPOSITORIES: biostudies-literature
Publications
Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission.
DeVito Nicholas J NJ Goldacre Ben B
JAMA internal medicine 20210801 8
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Project description:The vast volume of documents available in legal databases demands effective information retrieval approaches which take into consideration the intricacies of the legal domain. Relevant document retrieval is the backbone of the legal domain. The concept of relevance in the legal domain is very complex and multi-faceted. In this work, we propose a novel approach of concept based similarity estimation among court judgments. We use a graph-based method, to identify prominent concepts present in a judgment and extract sentences representative of these concepts. The sentences and concepts so mined are used to express/visualize likeness among concepts between a pair of documents from different perspectives. We also propose to aggregate the different levels of matching so obtained into one measure quantifying the level of similarity between a judgment pair. We employ the ordered weighted average (OWA) family of aggregation operators for obtaining the similarity value. The experimental results suggest that the proposed approach of concept based similarity is effective in the extraction of relevant legal documents and performs better than other competing techniques. Additionally, the proposed two-level abstraction of similarity enables informative visualization for deeper insights into case relevance.
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Project description:OBJECTIVES:To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. DESIGN:Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. PARTICIPANTS:Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. MAIN OUTCOME MEASURES:Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. RESULTS:Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100-500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. CONCLUSIONS:Despite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance.
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Project description:BackgroundResponsiveness to the Food and Drug Administration (FDA) rosiglitazone safety alert, issued on May 21, 2007, has not been examined among vulnerable subpopulations of the elderly.ObjectiveTo compare time to discontinuation of rosiglitazone after the safety alert between black and white elderly persons, and across sociodemographic and economic subgroups.Research designA cohort study.SubjectsMedicare fee-for-service enrollees in 2007 who were established users of rosiglitazone identified from a 20% national sample of pharmacy claims.MeasuresOutcome of interest was time to discontinuation of rosiglitazone after the May alert. We modeled the number of days following the warning to the end of the days' supply for the last rosiglitazone claim during the study period (May 21, 2007-December 31, 2007) using multivariable proportional hazards models.ResultsMore than 67% of enrollees discontinued rosiglitazone within six months of the advisory. In adjusted analysis, white enrollees (hazard ratio=0.90; 95% confidence interval, 0.86-0.94) discontinued rosiglitazone later than the comparison group of black enrollees. Enrollees with a history of low personal income also discontinued later than their comparison group (hazard ratio=0.84; 95% confidence interval, 0.81-0.87). There were no observed differences across quintiles of area-level socioeconomic status.ConclusionsWhite race and a history of low personal income modestly predicted later discontinuation of rosiglitazone after the FDA's safety advisory in 2007. The impact of FDA advisories can vary among sociodemographic groups. Policymakers should continue to monitor whether risk management policies reach their intended populations.
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Project description:ObjectivesTo estimate the effect of California's prescription drug monitoring program's (PDMP) registration mandate on use of the PDMP.MethodsWe evaluated the effect of California's mandatory PDMP registration law by fitting time series models on the percentage of clinicians registered for California's PDMP and the percentage of clinicians who were active PDMP users (users who created ≥ 1 patient prescription reports in a given month) from 2010 through 2017. We also compared PDMP use among early PDMP adopters (clinicians who registered > 8 months before the mandatory registration deadline) versus late adopters (clinicians who registered ≤ 8 months before the deadline).ResultsMandatory registration was associated with increases in active PDMP users: 53.5% increase for prescribers and 17.9% for pharmacists. Early adopters were 4 times more likely to be active PDMP users than were late adopters.ConclusionsMandatory registration was associated with increases in PDMP registration and use, but most new registrants did not become active users. Public Health Implications. Mandatory PDMP registration increases PDMP use but does not result in widespread PDMP usage by all clinicians prescribing controlled substances.
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Project description:ImportanceIn oncology randomized clinical trials, suboptimal access to best available care at recurrence (or relapse) may affect overall survival results.ObjectiveTo assess the proportion and the quality of postrecurrence treatment received by patients enrolled in US Food and Drug Administration (FDA) registration trials of systemic therapy in the adjuvant or neoadjuvant setting.Evidence reviewFor this systematic review, all trials leading to an FDA approval from January 2018 through May 2023 were obtained from the FDA website and drug announcements. Randomized clinical trials of an anticancer drug in the neoadjuvant or the adjuvant setting were included. Trials of supportive care treatment and treatments given in combination with radiotherapy were excluded. Information abstracted for each trial included tumor type, setting, phase, type of sponsor, reporting and assessment of postrecurrence, and overall survival data.FindingsA total of 14 FDA trials met the inclusion criteria. Postrecurrence data were not available in 6 of 14 registration trials (43%). Of the 8 remaining trials, postrecurrence treatment was assessed as suboptimal in 6 (75%). Overall, only 2 of 14 trials (14%) had data assessed as appropriate.Conclusions and relevanceThis systematic review found that 43% of randomized clinical trials of anticancer treatment in the adjuvant or neoadjuvant context failed to present any assessable postrecurrence treatment data. In instances in which these data were shared, postrecurrence treatment was suboptimal 75% of the time. The findings suggest that regulatory bodies should enforce rules stipulating that patients have access to the best standard of care at recurrence.
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Project description:Combined magnetic resonance imaging (MRI) and positron emission tomography/computed tomography (PET/CT) may enhance diagnosis, aid surgical planning and intra-operative orientation for prostate biopsy and radical prostatectomy. Although PET-MRI may provide these benefits, PET-MRI machines are not widely available. Image fusion of Prostate specific membrane antigen PET/CT and MRI acquired separately may be a suitable clinical alternative. This study compares CT-MR registration algorithms for urological prostate cancer care. Paired whole-pelvis MR and CT scan data were used (n = 20). A manual prostate CTV contour was performed independently on each patients MR and CT image. A semi-automated rigid-, automated rigid- and automated non-rigid registration technique was applied to align the MR and CT data. Dice Similarity Index (DSI), 95% Hausdorff distance (95%HD) and average surface distance (ASD) measures were used to assess the closeness of the manual and registered contours. The automated non-rigid approach had a significantly improved performance compared to the automated rigid- and semi-automated rigid-registration, having better average scores and decreased spread for the DSI, 95%HD and ASD (all p < 0.001). Additionally, the automated rigid approach had similar significantly improved performance compared to the semi-automated rigid registration across all accuracy metrics observed (all p < 0.001). Overall, all registration techniques studied here demonstrated sufficient accuracy for exploring their clinical use. While the fully automated non-rigid registration algorithm in the present study provided the most accurate registration, the semi-automated rigid registration is a quick, feasible, and accessible method to perform image registration for prostate cancer care by urologists and radiation oncologists now.
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