LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 10 of total 71

Search options

  1. Article ; Online: Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing.

    Zarin, Deborah A / Selker, Harry P

    Clinical therapeutics

    2022  Volume 44, Issue 3, Page(s) 439–441

    MeSH term(s) Clinical Trials as Topic ; Humans ; Motivation ; Research Design
    Language English
    Publishing date 2022-02-25
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 603113-4
    ISSN 1879-114X ; 0149-2918
    ISSN (online) 1879-114X
    ISSN 0149-2918
    DOI 10.1016/j.clinthera.2022.02.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1435: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 404: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  2. Article ; Online: The Culture of Trial Results Reporting at Academic Medical Centers.

    Zarin, Deborah A

    JAMA internal medicine

    2019  Volume 180, Issue 2, Page(s) 319–320

    MeSH term(s) Academic Medical Centers ; Universities
    Language English
    Publishing date 2019-11-15
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 2699338-7
    ISSN 2168-6114 ; 2168-6106
    ISSN (online) 2168-6114
    ISSN 2168-6106
    DOI 10.1001/jamainternmed.2019.4200
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.119: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article ; Online: Deprioritization of Ongoing Clinical Trials.

    Bierer, Barbara E / Zarin, Deborah A / Gelinas, Luke

    Ethics & human research

    2023  Volume 45, Issue 5, Page(s) 27–33

    Abstract: To be ethical, clinical trials must exhibit a favorable risk-benefit balance at the time of their initiation. However, in some cases, the expected value of a study decreases while the study is ongoing, due to developments outside of the study itself, ... ...

    Abstract To be ethical, clinical trials must exhibit a favorable risk-benefit balance at the time of their initiation. However, in some cases, the expected value of a study decreases while the study is ongoing, due to developments outside of the study itself, such as findings from other studies or an otherwise shifting evidence base. While such situations are acknowledged in the research community, they have not received sufficient attention, given the high costs of uninformative studies, both in material and human capital. In addition, the Covid-19 pandemic has exposed serious shortcomings with current approaches to monitoring studies for continued relevance and value. In this article, with reference to a case study from the Covid-19 pandemic, we identify and describe the importance and challenge of ensuring that clinical trials continue to exhibit scientific relevance and value once initiated. We explore the ethical dynamics of these situations and identify unresolved issues. While more empirical work is needed to ensure that proposed solutions to the issues are evidence based, we offer some provisional considerations that amount to a framework for approaching these challenging situations.
    MeSH term(s) Humans ; COVID-19 ; Pandemics ; Clinical Trials as Topic
    Language English
    Publishing date 2023-09-30
    Publishing country United States
    Document type Journal Article
    ISSN 2578-2363
    ISSN (online) 2578-2363
    DOI 10.1002/eahr.500180
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  4. Article ; Online: Trial Reporting and the Clinical Trials Enterprise.

    Zarin, Deborah A / Califf, Robert M

    JAMA internal medicine

    2021  Volume 181, Issue 8, Page(s) 1131–1132

    Language English
    Publishing date 2021-05-24
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 2699338-7
    ISSN 2168-6114 ; 2168-6106
    ISSN (online) 2168-6114
    ISSN 2168-6106
    DOI 10.1001/jamainternmed.2021.2041
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.119: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article ; Online: Monitoring the Pediatric Clinical Trials Enterprise.

    Califf, Robert M / Zarin, Deborah A

    Pediatrics

    2021  Volume 148, Issue 3

    MeSH term(s) Child ; Humans
    Language English
    Publishing date 2021-08-28
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 207677-9
    ISSN 1098-4275 ; 0031-4005
    ISSN (online) 1098-4275
    ISSN 0031-4005
    DOI 10.1542/peds.2021-051589
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Um IV Zs.131: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 357: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  6. Article ; Online: How to limit uninformative trials: Results from a Delphi working group.

    Gelinas, Luke / Hutchinson, Nora / Zarin, Deborah A / Bierer, Barbara E

    Med (New York, N.Y.)

    2023  Volume 4, Issue 4, Page(s) 226–232

    Abstract: To be justifiable, clinical trials must test novel hypotheses and produce informative results. However, many trials fail on this score. A Delphi process was used to establish consensus on 35 recommendations across five domains related to the role of ... ...

    Abstract To be justifiable, clinical trials must test novel hypotheses and produce informative results. However, many trials fail on this score. A Delphi process was used to establish consensus on 35 recommendations across five domains related to the role of scientific review in preventing uninformative trials.
    MeSH term(s) Delphi Technique ; Consensus
    Language English
    Publishing date 2023-04-11
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2666-6340
    ISSN (online) 2666-6340
    DOI 10.1016/j.medj.2023.03.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  7. Article ; Online: Lack of harmonization of coronavirus disease ordinal scales.

    Zarin, Deborah A / Rosenfeld, Stephen

    Clinical trials (London, England)

    2020  Volume 18, Issue 2, Page(s) 263–264

    MeSH term(s) COVID-19/drug therapy ; Coronavirus ; Coronavirus Infections/diagnosis ; Coronavirus Infections/epidemiology ; Humans ; SARS-CoV-2
    Language English
    Publishing date 2020-12-15
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774520972082
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5831: 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)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  8. Article ; Online: Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov.

    Gelinas, Luke / Morrell, Walker / Tse, Tony / Glazier, Ava / Zarin, Deborah A / Bierer, Barbara E

    Journal of clinical and translational science

    2023  Volume 7, Issue 1, Page(s) e185

    Abstract: Introduction: Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We ... ...

    Abstract Introduction: Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally funded trials available on ClinicalTrials.gov.
    Methods: We downloaded ICFs posted on ClinicalTrials.gov for treatment trials initiated on or after the revised Common Rule effective date. Trial records (
    Results: Of the 102 trial records, 76 had identifiable KI sections that were, on average, 10% of the total length of full ICF documents. KI readability grade level was not notably different from other sections of ICFs. Most KI sections were distinguished by section headers and included lists but contained few other formatting elements. Most KI sections included a subset of topics consistent with the basic elements of informed consent specified in the Common Rule.
    Conclusion: Many of the KI sections in the study sample aligned with practices suggested in the preamble to the revised Common Rule. Further, our results suggest that some KI sections were tailored in study-specific ways. Nevertheless, guidelines on how to write concise and comprehensible KI sections would improve the utility and readability of KI sections.
    Language English
    Publishing date 2023-08-14
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2023.605
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  9. Article ; Online: The proportion of randomized controlled trials that inform clinical practice.

    Hutchinson, Nora / Moyer, Hannah / Zarin, Deborah A / Kimmelman, Jonathan

    eLife

    2022  Volume 11

    Abstract: Prior studies suggest that clinical trials are often hampered by problems in design, conduct, and reporting that limit their uptake in clinical practice. We have described 'informativeness' as the ability of a trial to guide clinical, policy, or research ...

    Abstract Prior studies suggest that clinical trials are often hampered by problems in design, conduct, and reporting that limit their uptake in clinical practice. We have described 'informativeness' as the ability of a trial to guide clinical, policy, or research decisions. Little is known about the proportion of initiated trials that inform clinical practice. We created a cohort of randomized interventional clinical trials in three disease areas (ischemic heart disease, diabetes mellitus, and lung cancer) that were initiated between January 1, 2009 and December 31, 2010 using ClinicalTrials.gov. We restricted inclusion to trials aimed at answering a clinical question related to the treatment or prevention of disease. Our primary outcome was the proportion of clinical trials fulfilling four conditions of informativeness: importance of the clinical question, trial design, feasibility, and reporting of results. Our study included 125 clinical trials. The proportion meeting four conditions for informativeness was 26.4% (95% CI 18.9-35.0). Sixty-seven percent of participants were enrolled in informative trials. The proportion of informative trials did not differ significantly between our three disease areas. Our results suggest that the majority of randomized interventional trials designed to guide clinical practice possess features that may compromise their ability to do so. This highlights opportunities to improve the scientific vetting of clinical research.
    MeSH term(s) Humans ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2022-08-17
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2687154-3
    ISSN 2050-084X ; 2050-084X
    ISSN (online) 2050-084X
    ISSN 2050-084X
    DOI 10.7554/eLife.79491
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  10. Article ; Online: Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis.

    Sheng, Jacky / Feldhake, Emma / Zarin, Deborah A / Kimmelman, Jonathan

    Med (New York, N.Y.)

    2022  Volume 3, Issue 5, Page(s) 335–343.e6

    Abstract: Background: Human protection policies require assessment of how proposed clinical trials relate to prior and ongoing studies testing similar hypotheses. We assessed the extent to which clinical trial protocols cited relevant published and ongoing ... ...

    Abstract Background: Human protection policies require assessment of how proposed clinical trials relate to prior and ongoing studies testing similar hypotheses. We assessed the extent to which clinical trial protocols cited relevant published and ongoing clinical trials that would have been easily accessible with reference searches.
    Methods: We created a random sample of trial protocols using ClinicalTrials.gov, stratifying by industry and non-industry-sponsored studies. We then conducted reference searches to determine the extent to which protocols cited clinical trials with identical intervention-indication pairings that were accessible in PubMed and ClinicalTrials.gov at the time of trial initiation.
    Findings: Of the 101 trial protocols evaluated, 73 had at least one identified citable trial. None contained statements suggesting a systematic search for relevant clinical evidence. Of industry-sponsored trial protocols with at least one identified citable trial, 7 of 23 (30.4%) did not cite any published clinical trials and 10 of 33 (30.3%) did not cite any ongoing relevant trials. Of the non-industry-sponsored trial protocols with at least one identified citable trial, 5 of 28 (17.9%) did not cite any published clinical trials and 14 of 19 (73.7%) did not cite any ongoing trials.
    Conclusions: Clinical trial protocols undercite accessible, relevant trials and do not document systematic searches for relevant clinical trials. Consequently, ethics review committees often receive an incomplete picture of the research landscape if they review protocols similar to those deposited on ClinicalTrials.gov.
    Funding: This study was funded by the Canadian Institutes of Health Research and the Greenwall Foundation.
    MeSH term(s) Canada ; Clinical Trial Protocols as Topic ; Cross-Sectional Studies ; Humans ; PubMed ; Research Design
    Language English
    Publishing date 2022-04-08
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2666-6340
    ISSN (online) 2666-6340
    DOI 10.1016/j.medj.2022.03.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

To top