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  1. Article ; Online: Reply to E. Noguchi et al.

    Hwang, Thomas J

    JCO oncology practice

    2023  Volume 19, Issue 4, Page(s) 217

    Language English
    Publishing date 2023-01-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 3028198-2
    ISSN 2688-1535 ; 2688-1527
    ISSN (online) 2688-1535
    ISSN 2688-1527
    DOI 10.1200/OP.22.00832
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 7198: Show issues Location:
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    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: New legislation to promote paediatric studies for new cancer medicines.

    Hwang, Thomas J / Bourgeois, Florence T

    The Lancet. Oncology

    2022  Volume 23, Issue 8, Page(s) e368–e369

    MeSH term(s) Child ; European Union ; Humans ; Legislation, Drug ; Neoplasms/drug therapy
    Language English
    Publishing date 2022-07-25
    Publishing country England
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(22)00376-X
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5696: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 460: Show issues

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  3. Article ; Online: New Federal Incentives for Diversity in Clinical Trials.

    Hwang, Thomas J / Brawley, Otis W

    The New England journal of medicine

    2022  Volume 387, Issue 15, Page(s) 1347–1349

    MeSH term(s) Humans ; Clinical Trials as Topic/standards ; Cultural Diversity ; Federal Government ; Motivation ; United States
    Language English
    Publishing date 2022-10-08
    Publishing country United States
    Document type Journal Article
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMp2209043
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Ua VI Zs.34: Show issues Location:
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  4. Article ; Online: New EU regulation on health technology assessment of cancer medicines.

    Hwang, Thomas J / Vokinger, Kerstin N

    The Lancet. Oncology

    2022  Volume 23, Issue 2, Page(s) e58

    MeSH term(s) Antineoplastic Agents ; Drug and Narcotic Control ; European Union ; Humans ; Technology Assessment, Biomedical/legislation & jurisprudence
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2022-02-03
    Publishing country England
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(22)00008-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 5696: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 460: Show issues

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  5. Article ; Online: Advancing Patient-Centered Outcomes and Equity in Clinical Trials for BCG-Unresponsive Nonmuscle Invasive Bladder Cancer.

    Hwang, Thomas J / Davies, Benjamin J / Preston, Mark A

    JAMA oncology

    2023  Volume 9, Issue 11, Page(s) 1491–1492

    MeSH term(s) Humans ; BCG Vaccine/therapeutic use ; Urinary Bladder Neoplasms/drug therapy ; Immunotherapy ; Patient-Centered Care ; Neoplasm Invasiveness ; Neoplasm Recurrence, Local
    Chemical Substances BCG Vaccine
    Language English
    Publishing date 2023-09-07
    Publishing country United States
    Document type Journal Article
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2023.3304
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Clinical trials for paediatric cancers under new legislation in the USA.

    Hwang, Thomas J / Reaman, Gregory H / Bourgeois, Florence T

    The Lancet. Child & adolescent health

    2023  Volume 7, Issue 7, Page(s) e13

    MeSH term(s) Child ; Humans ; United States ; European Union ; Legislation, Drug ; Neoplasms/therapy
    Language English
    Publishing date 2023-06-22
    Publishing country England
    Document type Letter ; Comment
    ISSN 2352-4650
    ISSN (online) 2352-4650
    DOI 10.1016/S2352-4642(23)00125-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021.

    Patel, Neeraj G / Hwang, Thomas J / Woloshin, Steven / Kesselheim, Aaron S

    JAMA network open

    2023  Volume 6, Issue 1, Page(s) e2250991

    MeSH term(s) Humans ; Advertising ; Television ; Drug Industry
    Language English
    Publishing date 2023-01-03
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2022.50991
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Trends in Launch Prices and Price Increases for New Medicines for Urological Cancers.

    Hwang, Thomas J / Isaac-Wilkins, Symone / Trinh, Quoc-Dien

    The Journal of urology

    2022  Volume 208, Issue 3, Page(s) 514–516

    MeSH term(s) Humans ; Urologic Neoplasms/drug therapy
    Language English
    Publishing date 2022-06-27
    Publishing country United States
    Document type Editorial
    ZDB-ID 3176-8
    ISSN 1527-3792 ; 0022-5347
    ISSN (online) 1527-3792
    ISSN 0022-5347
    DOI 10.1097/JU.0000000000002825
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Ui VI Zs.91: Show issues Location:
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    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 331: Show issues

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  9. Article ; Online: Clinical Value of Molecular Targets and FDA-Approved Genome-Targeted Cancer Therapies.

    Tibau, Ariadna / Hwang, Thomas J / Molto, Consolacion / Avorn, Jerry / Kesselheim, Aaron S

    JAMA oncology

    2024  

    Abstract: Importance: The number of new genome-targeted cancer drugs has increased, offering the possibility of personalized therapy, often at a very high cost.: Objective: To assess the validity of molecular targets and therapeutic benefits of US Food and ... ...

    Abstract Importance: The number of new genome-targeted cancer drugs has increased, offering the possibility of personalized therapy, often at a very high cost.
    Objective: To assess the validity of molecular targets and therapeutic benefits of US Food and Drug Administration-approved genome-targeted cancer drugs based on the outcomes of their corresponding pivotal clinical trials.
    Design and settings: In this cohort study, all genome-targeted cancer drugs that were FDA-approved between January 1, 2015, and December 31, 2022, were analyzed. From FDA drug labels and trial reports, key characteristics of pivotal trials were extracted, including the outcomes assessed.
    Main outcomes and measures: The strength of evidence supporting molecular targetability was assessed using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT). Clinical benefit for their approved indications was evaluated using the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS). Substantial clinical benefit was defined as a grade of A or B for curative intent and 4 or 5 for noncurative intent. Molecular targets qualifying for ESCAT category level I-A and I-B associated with substantial clinical benefit by ESMO-MCBS were rated as high-benefit genomic-based cancer treatments.
    Results: A total of 50 molecular-targeted drugs covering 84 indications were analyzed. Forty-five indications (54%) were approved based on phase 1 or phase 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials, and 48 (57%) were approved on the basis of subgroup analyses. By each indication, 46 of 84 primary end points (55%) were overall response rate (median [IQR] overall response rate, 57% [40%-69%]; median [IQR] duration of response, 11.1 [9.2-19.8] months). Among the 84 pivotal trials supporting these 84 indications, 38 trials (45%) had I-A ESCAT targetability, and 32 (38%) had I-B targetability. Overall, 24 of 84 trials (29%) demonstrated substantial clinical benefit via ESMO-MCBS. Combining these ratings, 24 of 84 indications (29%) were associated with high-benefit genomic-based cancer treatments.
    Conclusions and relevance: The results of this cohort study demonstrate that among recently approved molecular-targeted cancer therapies, fewer than one-third demonstrated substantial patient benefits at approval. Benefit frameworks such as ESMO-MCBS and ESCAT can help physicians, patients, and payers identify therapies with the greatest clinical potential.
    Language English
    Publishing date 2024-04-04
    Publishing country United States
    Document type Journal Article
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2024.0194
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Reforming Patient Cost Sharing for Cancer Medications in Medicare Part D.

    Hwang, Thomas J / Kesselheim, Aaron S / Dusetzina, Stacie B

    JAMA oncology

    2022  Volume 8, Issue 10, Page(s) 1398–1400

    MeSH term(s) Aged ; Humans ; United States ; Medicare Part D ; Cost Sharing ; Neoplasms/drug therapy
    Language English
    Publishing date 2022-08-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2022.2828
    Database MEDical Literature Analysis and Retrieval System OnLINE

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