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  • Clinical Study Reports (CSR) Used in the Systematic Review of Neuraminidase Inhibitors for Preventing and Treating Influenza in Healthy Adults and Children with Confirmed or Suspected Exposure to Natural Influenza
    UMB Dataset

    Alternate Title(s)
    CSRs used in Cochrane review of neuroaminidase inhibitors for influenza
    Authors
    Peter Doshi
    Description

    Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors. A systematic review of the CSRs and other regulatory documents was conducted to determine the potential benefits and harms of oseltamivir (Tamiflu) and zanamivir (Relenza). Outcome measures included time to first alleviation of symptoms, influenza outcomes, complications, admissions to hospital, and adverse events in the intention to treat population. Completeness of relevant parts of the CSRs was determined via an extraction form based on the CONSORT statement checklist. Authors have provided the full set of clinical study reports for both medications provided to the Cochrane collaboration by Roche, GlaxoSmithKline, and the European Medicines Agency (EMA) for use in the systematic review of these neuraminidase inhibitors for treating/preventing influenza in healthy adults and children. A guest post on the "Dryad News and Views" site regarding the dataset of clinical study reports and the resulting Cochrane systematic review is available at: https://blog.datadryad.org/2014/04/17/tamiflu-data/

    Subject
    Influenza, Human
    Access Rights
    Free to All
  • Dataset (data extraction spreadsheet) of an Exploratory Review of Clinical Study Reports of Randomised Controlled Trials
    UMB Dataset

    Authors
    Peter Doshi
    Tom Jefferson
    Description

    This dataset (data extraction spreadsheet) is associated with an exploratory evaluation of pharmaceutical industry clinical study reports (CSR) for possible use in evidence synthesis and systematic reviews. 78 CSRs from public sources were selected for data extraction. The report dates range from 1991 through 2011, inclusive, and represent 90 randomized controlled trials of 14 pharmaceuticals. The primary outcome measures include presence and length of essential elements of trial design and reporting and compression factor (ratio of page length for CSRs compared to its published counterpart in a scientific journal). The dataset is comprised of an audited table of extracted and derived variables the details for which are described in an accompanying readme file. The uncorrected (original) and corrected extraction sheets as well as audit records are available upon request from Peter Doshi, corresponding author (pdoshi@rx.umaryland.edu).

    Subject
    Drug Industry
    Access Rights
    Free to All
  • Patient Consent to Publication and Data Sharing in Industry and NIH-Funded Clinical Trials
    UMB Dataset

    Authors
    O'Mareen Spence
    Richie Onwuchekwa Uba
    Seongbin Shin
    Peter Doshi
    Description

    Clinical trial participants are often motivated by the altruistic assumption that study results will contribute to medical knowledge. Additionally, the sharing of research data is rapidly developing into an ethical standard. An evaluation of 144 blank (sample) informed consent forms (ICF) was undertaken to determine the extent to which clinical trial participants were apprised of researchers’ intent to publish results, share de-identified data, and the overall benefit to medical knowledge. This dataset consists of 98 ICFs from industry-funded trials from the European Medicines Agency (EMA) and 46 ICFs from publicly-funded trials listed in the National Heart, Lung and Blood Institute (NHLBI) Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). The documents were reviewed for identification and extraction of stated or implied language for the following 5 aspects of each study: publication of results, sharing de-identified data, data ownership, confidentiality of identifiable data and, whether the trial will produce knowledge that offers public benefit. Results indicate that investigators rarely disclose intent to share de-identifiable data or commitment to publish. All ICFs are available via 2 zip files, one for the industry-funded trials and the other for the trials in BioLINCC. Also included is the study extraction sheet.

    Subject
    Informed Consent
    Access Rights
    Free to All
  • The Possible Harms of Statins: What do Product Labels, Patient Package Inserts, and Pharmacy Leaflets Tell Us?
    UMB Dataset

    Authors
    Peter Doshi
    Jan Sieluk
    Anna Hung
    Description

    This cross-sectional study evaluated three sources of written medical documents for consistency of language with regard to the adverse effects of 8 single-agent statins. Full prescribing information (PI’s, also called package inserts or drug labels), patient package inserts (PPIs), and pharmacy leaflets differ according to regulatory status, issuing body, and intended audience. The first two sources are regulated by the FDA and provided by drug manufacturers. PIs are written for health care professionals and PPIs for both practitioners and patients. Pharmacy leaflets are not regulated, typically produced by vendors, and intended for patient use. The statin documents were searched for language associated with 7 adverse events: diarrhea, arthralgia, dyspepsia, confusion, memory loss, rhabdomyolysis, and kidney failure. Data were collected verbatim and coded according to the statements describing the relationship between the drug and specific harm. Consistency of language was calculated comparing PIs and PPIs, PPIs and pharmacy leaflets, and PIs and leaflets. This dataset includes all prescribing information (drug labels), patient package inserts, and pharmacy leaflets used in the study as well as the extraction sheets.

    Subject
    Consumer Health Information/standards
    Drug Labeling/standards
    Timeframe
    2015
    Access Rights
    Free to All
  • Dataset for Communicating Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone
    UMB Dataset

    Authors
    Peter Doshi
    O'Mareen Spence
    Aida Kuzucan
    John H. Powers, III
    Description

    This dataset is the result of an investigation characterizing nonefficacy benefits of newly approved molecular entities (NMEs) based exclusively on noninferiority trials. Qualifying NMEs were identified using the FDA’s Novel Drug Approval website, sponsor press releases at market entry, FDA Drug Trials Snapshots, and statistical and medical officer reports. A total of 18 were selected for analysis. All FDA and sponsor nonefficacy benefit statements were extracted and categorized. Additionally, the IBM Micromedex Red Book was consulted for average unit prices for drug cost comparisons. The dataset includes all information sources for the NMEs as well as the noninferiority data extraction sheet.

    Subject
    Drug Industry
    Equivalence Trials as Topic
    Human Experimentation/ethics
    United States. Food and Drug Administration
    Access Rights
    Free to All
  • Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling
    UMB Dataset

    Authors
    Peter Doshi
    Bansri Desai
    Kyungwan Hong
    John H. Powers, III
    Description

    Clinicians prescribing therapeutic agents newly approved by the FDA must rely on the information reported through drug labels (also known as “package inserts”). Ideally, labels should incorporate details regarding key efficacy information, including the magnitude of treatment benefit, and measures of precision and random error (confidence intervals and p values). This study assessed the degree to which they actually provide this information. Original drug labels for all new molecular entities (NMEs) approved by the FDA between January 2015 and March 2018 were downloaded from the Drugs@FDA online database. NMEs not treating or preventing diseases or conditions and not tested in controlled trials were excluded. For each indication, the primary efficacy outcome was extracted and the presence or absence of the following attributes describing treatment effects were recorded: point estimates, confidence intervals, and p values. This dataset includes all data extracted and coded as well as copies of the original drug labels used in the study.

    Subject
    Drug Labeling/standards
    Access Rights
    Free to All
  • Nationwide Readmissions Database

    Alternate Title(s)
    NRD, HCUP Nationwide Readmissions Database
    Description

    The Nationwide Readmissions Database is part of the Healthcare Cost and Utilization Project (HCUP) family of databases. The NRD is derived from the HCUP State Inpatient Databases (SID), and aims to provide nationally represenative data to support hospital readmission analyses. The NRD includes all-payer inpatient discharges from HCUP partner community hospitals in the SID which have verifiable patient linkage numbers. These synthetic linkage numbers allow analysts to track patients across hospital stays, while maintaining patient privacy. The NRD contains over 14 million discharge records per data year from about 85% of SID discharges from participating states. The 122 data elements in the NRD include diagnostic and procedure codes, and hospital characteristics. The data cannot be used to track readmissions across states or across data years or used for state-, facility-, or physician-level analyses.

    Subject
    Hospitalization
    Patient Readmission
    Quality of Health Care
    Geographic Coverage
    United States
    Access Rights
    Requires fee, application, and data use agreement
    Local Experts
    Najdat Bazarbashi
  • Heroin in Transition Study (HIT)
    UMB Dataset

    Authors
    Daniel Ciccarone
    George J. Unick
    Jenny K. Cohen
    Sarah G. Mars
    1 more author(s)...
    Description

    Dataset comprises hospitalization rates for opioid injection-related skin and soft-tissue infections (O-SSTI) correlated with changes in the price and purity of heroin for the years 1993 through 2010, inclusive. Data is derived from the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) and the Drug Enforcement Administration (DEA) System to Retrieve Information from Drug Evidence (STRIDE) databases for 27 Metropolitan Statistical Areas (MSAs).

    Subject
    Substance-Related Disorders
    Geographic Coverage
    United States
  • US Regional and Demographic Differences in Prescription Opioid and Heroin-Related Overdose Hospitalizations
    UMB Dataset

    Authors
    George J. Unick
    Daniel Ciccarone
    Description

    Dataset is comprised of heroin overdose-related and prescription opioid overdose-related hospitalization rates for the years 2000 through 2014. Data is derived from the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS). Included are rates by census region and division with separate rates for age and race.

    Subject
    Substance-Related Disorders
    Geographic Coverage
    United States
  • National Survey of State Medicaid Psychotropic-Monitoring Programs Targeting Youth
    UMB Dataset

    Authors
    Susan dosReis
    Ming-Hui Tai
    Wendy Castillo Camelo
    Gloria Reeves
    Description

    Officials from Medicaid programs in all 50 states and the District of Columbia were invited to participate in a telephone survey assessing psychotropic-monitoring programs targeting youth. 38 completed the survey which was administered between August 2011 and December 2012. This dataset includes information about program characteristics, implementation strategies, review agency, professional oversight, periodic review, psychotropic drug class, concomitant use, and prescriber credentials.

    Subject
    Medicaid
    Psychotropic Drugs
    Geographic Coverage
    United States

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