Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies

被引:43
|
作者
Miller, Jennifer E. [1 ,2 ]
Wilenzick, Marc [3 ]
Ritcey, Nolan [2 ]
Ross, Joseph S. [4 ,5 ,6 ,7 ]
Mello, Michelle M. [8 ,9 ]
机构
[1] NYU, Sch Med, Div Med Eth, Dept Populat Hlth, New York, NY 10003 USA
[2] Bioeth Int, New York, NY 10017 USA
[3] Int Aids Vaccine Initiat, New York, NY USA
[4] Yale Sch Med, Sect Gen Internal Med, New Haven, CT USA
[5] Yale Sch Med, Robert Wood Johnson Fdn Clin Scholars Program, Dept Med, New Haven, CT USA
[6] Yale Sch Publ Hlth, Dept Hlth Policy & Management, New Haven, CT USA
[7] Yale New Haven Hlth, Ctr Outcomes Res & Evaluat, New Haven, CT USA
[8] Stanford Univ, Stanford Law Sch, Stanford, CA USA
[9] Stanford Univ, Stanford Law Sch, Dept Hlth Res & Policy, Stanford, CA USA
来源
BMJ OPEN | 2017年 / 7卷 / 12期
关键词
bioethics; clinical pharmacology; clinical trial transparency; good pharma scorecard; health Policy; law (see medical law); medical ethics; pharma ethics; public health;
D O I
10.1136/bmjopen-2017-017917
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs. Design Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies. Data sources Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials. gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers. Outcome measures Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level. Results The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials. gov; 0 trials were uniquely registered in international registries. Conclusions Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies' transparency records and recognise exemplary companies may encourage further progress.
引用
收藏
页数:11
相关论文
共 50 条
  • [31] Pharmaceutical Companies vs. the State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?
    Wang, Daniel Wei L.
    Ferraz, Octavio Luiz Motta
    JOURNAL OF LAW MEDICINE & ETHICS, 2012, 40 (02): : 188 - 196
  • [32] Environmental effects of sustainability management tools: An empirical analysis of large companies
    Hoerisch, Jacob
    Ortas, Eduardo
    Schaltegger, Stefan
    Alvarez, Igor
    ECOLOGICAL ECONOMICS, 2015, 120 : 241 - 249
  • [33] INTERNAL ORGANIZATION AND PROFIT - EMPIRICAL-ANALYSIS OF LARGE UK COMPANIES
    STEER, P
    CABLE, J
    JOURNAL OF INDUSTRIAL ECONOMICS, 1978, 27 (01): : 13 - 30
  • [34] Clinical Trial Transparency and Orphan Drug Development: Recent Trends in Data Sharing by the Pharmaceutical Industry
    So, D.
    Joly, Y.
    Knoppers, B. M.
    PUBLIC HEALTH GENOMICS, 2013, 16 (06) : 322 - 335
  • [35] The Therapeutic Target Database: an Internet resource for the primary targets of approved, clinical trial and experimental drugs
    Liu, Xin
    Zhu, Feng
    Ma, Xiaohua
    Tao, Lin
    Zhang, Jingxian
    Yang, Shengyong
    Wei, Yuquan
    Chen, Yu Zong
    EXPERT OPINION ON THERAPEUTIC TARGETS, 2011, 15 (08) : 903 - 912
  • [36] Evaluation of clinical trial designs for novel anticancer drugs in China: A cohort study of drugs approved between 2015 and 2021
    Luo, Xingxian
    Guo, Qixiang
    Du, Xin
    Huang, Lin
    Chow, Shein-Chung
    Yang, Yue
    DRUG DISCOVERY TODAY, 2023, 28 (06)
  • [37] A review of clinical trial designs of typical orphan drugs approved by the Food and Drug Administration.
    Haffner, M
    Bona, J
    Centeno-Deshields, D
    Nguyen, T
    Ott, C
    Whitley, J
    JOURNAL OF CLINICAL PHARMACOLOGY, 2005, 45 (09): : 1089 - 1089
  • [38] Comparison of Clinical Trial Results of the Recently Approved Immunotherapeutic Drugs for Advanced Biliary Tract Cancers
    Das, Samayita
    REVIEWS ON RECENT CLINICAL TRIALS, 2024, 19 (02) : 81 - 90
  • [39] Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis
    Chen, Krista Y.
    Borglund, Erin M.
    Postema, Emma Charlotte
    Dunn, Adam G.
    Bourgeois, Florence T.
    CLINICAL TRIALS, 2022, 19 (04) : 442 - 451
  • [40] Analysis of Drug-Drug Interaction Labeling Language and Clinical Recommendations for Newly Approved Drugs Evaluated With Digoxin, Midazolam, and S-Warfarin
    Henderson, Lindsay M.
    Steinbronn, Claire E.
    Yu, Jingjing
    Yeung, Catherine K.
    Ragueneau-Majlessi, Isabelle
    CLINICAL THERAPEUTICS, 2021, 43 (11) : 2032 - 2039