Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013

Cruz, Marisa; Xu, Jie; Kashoki, Mwango; Lurie, Peter

doi:10.1001/jamainternmed.2017.1313

Cited by 9 publications

(10 citation statements)

References 2 publications

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“…Our finding that about three quarters of the postmarket clinical trials had either reported results or were published is consistent with a recent study by the FDA, which showed that nearly two thirds of postmarket drug interventional clinical trials and other trials designated as “fulfilled” were published in either the scientific literature or on the ClinicalTrials.gov website 16. However, only 55.5% of postmarket studies for which publication would be expected were published in peer-reviewed medical journals.…”

Section: Discussionsupporting

confidence: 90%

“…In particular, the FDA might need to provide additional clarity to sponsors about which trials need to be registered and when results need to be reported. Furthermore, new regulations might be needed to ensure that the results from postmarket studies that are of most interest to the clinical community, including prospective cohort studies and registries, are publicly disseminated 16. Alternatively, sponsors can also voluntarily take on part of the responsibility and commit to greater registration and results dissemination.…”

Section: Discussionmentioning

confidence: 99%

“…In 2007, the US FDA Amendments Act (FDAAA) was enacted, which mandated registration and results reporting on a publicly accessible clinical trial registry established by the National Institutes of Health, ClinicalTrials.gov, for all ongoing and forthcoming “applicable clinical trials” of FDA regulated products 1415. According to a recent internal evaluation by the FDA, over one third of fulfilled postmarket interventional clinical trials and other trials were not published in either the scientific literature or on the ClinicalTrials.gov website 16. However, the authors were able to rely on internal agency information, as opposed to information that is available to the public, and did not examine the proportion of all clinical study postmarketing requirements that were fulfilled, the rigor of the evidence generated, or the timeliness of results reporting.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis

Wallach

Egilman

Dhruva

et al. 2018

BMJ

107

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis

Wallach

Egilman

Dhruva

et al. 2018

BMJ

107

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“…Prior studies have focused exclusively on the characteristics [7], completion [8, 9], and dissemination of postmarketing requirements [7, 10, 11]. For instance, among the 110 new drugs and biologics approved by FDA between 2009 and 2012, 97 (88.2%) had at least one postmarketing requirement at the time of approval (Fig.…”

Section: Introductionmentioning

confidence: 99%

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Wallach

Luxkaranayagam

Dhruva

et al. 2019

BMC Med

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Background Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation. As FDA increasingly adopts a lifecycle evaluation process, greater emphasis will be placed on postmarket evidence as a component of therapeutic evaluation. Therefore, the objectives of this study were to determine how often postmarketing commitments agreed upon by pharmaceutical companies at first FDA approval lead to new clinical trials and to establish the characteristics and rates of completion and dissemination of postmarketing commitments. Methods For new drugs and biologics approved in 2009–2012, we used public FDA documents, ClinicalTrials.gov, and Scopus, to determine postmarketing commitments and their characteristics known at the time of FDA approval; number subject to reporting requirements, for which FDA is required to make study status information available to the public (“506B studies”), and their statuses; and rates of registration and results reporting on ClinicalTrials.gov and publication in peer-reviewed journals for all clinical trials. Results Among 110 novel drugs and biologics approved by the FDA between 2009 and 2012, 61 (55.5%) had at least one postmarketing commitment at the time of first approval. Of 331 total postmarketing commitments, 33 (10.0%) were for new clinical trials; 27 of these were 506B studies subject to public reporting requirements, of which 12 (44.4%) did not have a recent (i.e., up-to-date) or closed (i.e., fulfilled or released) status provided publicly by the FDA. Although two postmarketing commitments were insufficiently described in FDA records to perform searches on ClinicalTrials.gov, nearly all (28, 90.3%) of the 31 remaining postmarketing commitments for new clinical trials were registered on ClinicalTrials.gov. Among the registered trials, 23 (23 of 28, 82.1%) were classified as completed or terminated, of which 22 (95.7%) had reported results. When considering all 29 completed or terminated clinical trials, registered or unregistered on ClinicalTrials.gov, only half (14, 48.3%) were published in peer-reviewed journals. Conclusions While only 15% of postmarketing commitments agreed to by pharmaceutical companies at the time of FDA approval were for new clinical trials, these trials were nearly always registered with reported results on ClinicalTrials.gov. However, only half were published, and despite FDA public reporting requirements, recent status information was often unavailable for 506B studies. Electronic supplementary material The online version of this article (10.1186/s12916-019-1344-3) contains supplementary material, which is available to authorized users.

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“…2 Furthermore, nearly one quarter of PMR results are either not reported on ClinicalTrials.gov or published in the peer-reviewed literature. 3,4 Therefore, our objective was to characterize the timeliness of PMR studies, comparing FDAestablished timeliness milestones with expected completion times outlined on ClinicalTrials.gov.…”

Section: Introductionmentioning

confidence: 99%

Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis

et al. 2018

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Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013

Cited by 9 publications

References 2 publications

Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis

Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis

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