Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
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Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
Yale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019Impa Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating act OfFdaaa On Registration, Results Reporting, And Publication of Clinical Trials Evaluating New Neuropsychiatric Drugs Approved Between 2005 And 2014Constance Xuanyi ZouFollow this and additional works at: https://elischolar.library.yale.edu/ymtdlRecommended CitationZou, Constance Xtunyi, 'Impact Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating Of Fdaaa On Registration, Results Reporting. And Publication Of Clinical Trials Evaluating New Neuropsychiatric Drugs Approved Between 200$ And 2014'Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
(2019). Yale Mediant ThtiisDigital Library. 3S47.https://elbcholar.library.yale.edu/)-mtdl/SS47Ulis Open Access Ihesas ks brought to you tor free and Yale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019Impa Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating icine Thesis Digital Library by an authorized administrator of EliSchobr - A Digital Platform for Scholarly Publishing at Yale. For more information, please contact elischoiariSy-ale.edu.Impact of FDAAA on Registration, Results Reporting, andPublication of Clinical Trials Evaluating NewNeuropsychiat Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating ric Drugs Approved between 2005 and 2014A Thesis Submitted to rhe Yale University' School of Medicine in Partial Fulfillment of the Requirements for tLuận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
he Degree of Doctor of Medicineby-Constance Xuanyi ZouClass of 2019AbstractIMPACT OF FDAAA ON REGISTRATION. RESULTS REPORTING, AND PUBLICATION OF CLINYale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019Impa Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating ano. Harlan M. Krumholz, Jennifer E. Miller, Joseph s. RossCenter for Outcome Research and Evaluation. Department of Medicine. Yale University School of Medicine and Yale-New Haven Hospital, New Haven, ConnecticutEvidence-based medicine (EBM) promotes the use of randomized controlled trials (RCTs) p Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating ublished in peer reviewed medical journals as the "gold standard”. However, up to 50% of the completed clinical trials are never published and trialsLuận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
with results in favor of studied interventions are 2-4 times more likely to have been published then those with non favorable results. Publication biaYale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019Impa Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating ater results reporting, were proposed to mitigate selective clinical trial publication and outcome reporting. Congress enacted the FDA Amendments Act (1'DAAA) on September 27. 2007 requiring the registration of all non-phasc 1 clinical trials involving FDA-regulated medical interventions and results Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating reporting for FDA approved drugs. It's been 10 years since 1DAAA enactment, the impact of 1DAAA on the selective publication of clinical trials has nLuận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
ot been studied. Our objective is to determine whether FDAAA enactment is associated with improvements in trialregistration and results reporting, as Yale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019Impa Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating icacy trials supporting FDA new drug approval between 2005 to 2014 for neuropsychiatric indications. Trials were categorized as pre- or post-FDAAA based on initiation and/or completion dates as outlined by the statue. The main outcomes were the proportions of trials registered, proportions reported Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating results in ClinicalTrials.gov. and the degree of publication bias. Publication bias was estimated using the relative risks pre- and post-FDAAA of bothLuận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
the publication of positive vs non-positive trials, as well as of publishing positive vs. non-positive trials without misleading interpretations. RegYale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019Impa Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating ere compared by calculating the ratio of relative risks (RRR) for each period. Our study sample included 101 Pre-FDAAA and 41 Post-FDAAA efficacy trials supporting the FDA approval of 37 new dnigs for neuropsychiatric indications between 2005 and 2014. Post-FDAAA trials were significantly more likel Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating y to be registered (100% vs 64%: P'-O.OOl) and report results (100% vs 10%; P<0.001) than pre-FDAAA trials. Pre-FDAAA. positive trials were more likelLuận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
y to be published (RR=1.52; 95% Confidence Interval [CI]=1.17-1.99: P=0.002) and published without misleading interpretations (RR=2.47; Cl=l.57-3.73: Yale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019Impa Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating , and published without misleading interpretations (RR= 1.20: Cl=0.84-1.72; p=0.30). The likelihood of publication bias pre-FDAAA vs. post-FDAAA was greater for publication of positive vs. non-positive trials (RRR=1.52; Cl= 1.16-1.99: p=0.002) and for publication without misleading interpretations ( Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating RRR=2.06. Cl= 1.17-3.61. p=0.01). The enactment of FDAAA was followed by significantly higher proportions of trials that were registered and reportedhLuận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
ttps://khothuvien.cori!results on ClinicalTrials.gov. and with significantly lower degrees of publication bias among trials supporting recent FDA apprYale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019Impa Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating ) for his outstanding peer mentorship. We thank the organizers of the Eighth International Peer Review Congress (PRC?) for giving US the opportunity to present our work,-and the editors and reviewers who helped us publish our manuscripts in Trials.1 Video recording of Ms. Zou’s presentation has been Luận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating made available by the meeting organizer through Youtube, https: youtu.be yDKwxE81Tk4- Zou ex. Becker JE. Phillips AT. et al. Registration, results reLuận văn thạc sĩ impact of fdaaa on registration, results reporting, and publication of clinical trials evaluating
porting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort studYale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019ImpaYale UniversityEliScholar - A Digital Platform for Scholarly Publishing at YaleYale Medicine Thesis Digital LibrarySchool of MedicineJanuary' 2019ImpaGọi ngay
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