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  1. Article: Ethical rationale for better coordination of clinical research on COVID-19.

    Bompart, Francois

    Research ethics

    2020  Volume 16, Issue 3-4, Page(s) 1–10

    Abstract: Hundreds of clinical trials of potential treatments and vaccines for the "coronavirus 19 disease" (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical ... ...

    Abstract Hundreds of clinical trials of potential treatments and vaccines for the "coronavirus 19 disease" (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the burden of clinical trial involvement even though their trial cannot be completed as researchers are competing for patients. A shortage of medicines can occur when existing drugs are diverted for clinical trials. Research ethics committees are overburdened with multiple applications. A multitude of trials can also overstretch medical staff and risk neglecting non-COVID-19 patients. And finally, conflicting conclusions from a multitude of heterogeneous trials might lead to delays in public health decisions about life-saving issues. These challenges are made worse by the unpredictable evolution of epidemics, the active involvement of political decision-makers in scientific issues and the pressure of social media globally. While freedom to conduct research must be safeguarded, global health emergency situations would greatly benefit from effective international coordination mechanisms for clinical research.
    Language English
    Publishing date 2020-09-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 2663626-8
    ISSN 2047-6094 ; 1747-0161
    ISSN (online) 2047-6094
    ISSN 1747-0161
    DOI 10.1177/1747016120931998
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Ethical rationale for better coordination of clinical research on COVID-19

    Francois Bompart

    Research Ethics Review, Vol

    2020  Volume 16

    Abstract: Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical ... ...

    Abstract Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the burden of clinical trial involvement even though their trial cannot be completed as researchers are competing for patients. A shortage of medicines can occur when existing drugs are diverted for clinical trials. Research ethics committees are overburdened with multiple applications. A multitude of trials can also overstretch medical staff and risk neglecting non-COVID-19 patients. And finally, conflicting conclusions from a multitude of heterogeneous trials might lead to delays in public health decisions about life-saving issues. These challenges are made worse by the unpredictable evolution of epidemics, the active involvement of political decision-makers in scientific issues and the pressure of social media globally. While freedom to conduct research must be safeguarded, global health emergency situations would greatly benefit from effective international coordination mechanisms for clinical research.
    Keywords Ethics ; BJ1-1725 ; covid19
    Subject code 170
    Language English
    Publishing date 2020-07-01T00:00:00Z
    Publisher SAGE Publishing
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Ethical rationale for better coordination of clinical research on COVID-19

    Bompart, Francois

    Research Ethics

    2020  Volume 16, Issue 3-4, Page(s) 1–10

    Abstract: Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical ... ...

    Abstract Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the burden of clinical trial involvement even though their trial cannot be completed as researchers are competing for patients. A shortage of medicines can occur when existing drugs are diverted for clinical trials. Research ethics committees are overburdened with multiple applications. A multitude of trials can also overstretch medical staff and risk neglecting non-COVID-19 patients. And finally, conflicting conclusions from a multitude of heterogeneous trials might lead to delays in public health decisions about life-saving issues. These challenges are made worse by the unpredictable evolution of epidemics, the active involvement of political decision-makers in scientific issues and the pressure of social media globally. While freedom to conduct research must be safeguarded, global health emergency situations would greatly benefit from effective international coordination mechanisms for clinical research.
    Keywords covid19
    Language English
    Publisher SAGE Publications
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2663626-8
    ISSN 2047-6094 ; 1747-0161
    ISSN (online) 2047-6094
    ISSN 1747-0161
    DOI 10.1177/1747016120931998
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Ethical rationale for better coordination of clinical research on COVID-19

    Bompart, Francois

    Res Ethics

    Abstract: Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical ... ...

    Abstract Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” (COVID-19) have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the burden of clinical trial involvement even though their trial cannot be completed as researchers are competing for patients. A shortage of medicines can occur when existing drugs are diverted for clinical trials. Research ethics committees are overburdened with multiple applications. A multitude of trials can also overstretch medical staff and risk neglecting non-COVID-19 patients. And finally, conflicting conclusions from a multitude of heterogeneous trials might lead to delays in public health decisions about life-saving issues. These challenges are made worse by the unpredictable evolution of epidemics, the active involvement of political decision-makers in scientific issues and the pressure of social media globally. While freedom to conduct research must be safeguarded, global health emergency situations would greatly benefit from effective international coordination mechanisms for clinical research.
    Keywords covid19
    Publisher PMC
    Document type Article ; Online
    DOI 10.1177/1747016120931998
    Database COVID19

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  5. Article ; Online: Artesunate- and amodiaquine-associated extrapyramidal reactions: information gained from an African-based risk management plan.

    Bompart, François

    Drug safety

    2013  Volume 36, Issue 1, Page(s) 71–72

    MeSH term(s) Adverse Drug Reaction Reporting Systems/statistics & numerical data ; Amodiaquine/adverse effects ; Antimalarials/adverse effects ; Artemisinins/adverse effects ; Basal Ganglia Diseases/chemically induced ; Female ; Humans ; Male
    Chemical Substances Antimalarials ; Artemisinins ; Amodiaquine (220236ED28)
    Language English
    Publishing date 2013-01-15
    Publishing country New Zealand
    Document type Letter ; Comment
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-012-0010-x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: The VolREthics initiative to protect the well-being of healthy volunteers in biomedical research.

    Bompart, François / Fisher, Jill A / Allen, Elizabeth / Sevene, Esperança / Kumar, Nandini / Chew, Chun Keat / Fink, Valeria / Lanzerath, Dirk / Hirsch, François

    Nature medicine

    2023  Volume 29, Issue 10, Page(s) 2393–2394

    MeSH term(s) Humans ; Healthy Volunteers ; Research Subjects ; Biomedical Research
    Language English
    Publishing date 2023-08-12
    Publishing country United States
    Document type Letter
    ZDB-ID 1220066-9
    ISSN 1546-170X ; 1078-8956
    ISSN (online) 1546-170X
    ISSN 1078-8956
    DOI 10.1038/s41591-023-02490-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: VolREthics - Une initiative internationale de l’Inserm pour définir la protection des volontaires sains.

    Karkar, Meriem / Lemaitre, Christine / Bompart, François / Eisinger, François / Lombrail, Pierre / Mathieu, Flavie / Remy-Jouet, Isabelle / Sébastiani, Corinne / Lennad, Lou / Hirsch, François

    Medecine sciences : M/S

    2023  Volume 39, Issue 10, Page(s) 769–775

    Abstract: Healthy volunteers participating in biomedical research benefit from varying levels of protection in different parts of the world since they are too rarely identified as a specific subset of study participants with specific vulnerabilities and risks. ... ...

    Title translation Healthy volunteers' protection around the world.
    Abstract Healthy volunteers participating in biomedical research benefit from varying levels of protection in different parts of the world since they are too rarely identified as a specific subset of study participants with specific vulnerabilities and risks. These differences in protection can lead to unfair and ethically unacceptable situations. Healthy volunteers are subject to a number of risks, not only regarding the respect of their rights and of their health but they are also at risk of being exploited because of their financial situation, educational level and motivations. In the end, the scientific validity of the studies may also be called into question. Through its work, the VolREthics (Volunteers in Research and Ethics) initiative, set up by the Inserm ethics committee, outlines the ethical issues raised by the involvement of healthy volunteers in biomedical research, and highlights the need to improve their protection worldwide. Healthy volunteers are essential to scientific progress and society, and their potential vulnerabilities must be recognized and taken into account.
    MeSH term(s) Humans ; Healthy Volunteers ; Biomedical Research ; Educational Status ; Motivation
    Language French
    Publishing date 2023-11-09
    Publishing country France
    Document type English Abstract ; Journal Article
    ZDB-ID 632733-3
    ISSN 1958-5381 ; 0767-0974
    ISSN (online) 1958-5381
    ISSN 0767-0974
    DOI 10.1051/medsci/2023118
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Vaccination strategies for the last stages of global polio eradication.

    Bompart, Francois

    Indian pediatrics

    2005  Volume 42, Issue 2, Page(s) 163–169

    Abstract: Launched in 1988, the Global Poliomyelitis Eradication Initiative has enjoyed remarkable success. The WHO anticipates isolation of the last wild polio virus during late 2004/early 2005, paving the way for certification of a world free of polio in 2008. ... ...

    Abstract Launched in 1988, the Global Poliomyelitis Eradication Initiative has enjoyed remarkable success. The WHO anticipates isolation of the last wild polio virus during late 2004/early 2005, paving the way for certification of a world free of polio in 2008. However, the ultimate objective of this campaign, discontinuation of polio vaccination, has been jeopardised by two recent developments: the characterisation of vaccine-derived polio viruses (VDPV), and renewed concerns over the risk of bioterrorism. The threat posed by VDPV has led the WHO to recommend discontinuation of OPV usage as soon as possible after eradication certification. Cessation of vaccination with OPV needs to be carefully designed to avoid creating conditions where VDPV will develop. For the longer term, strategies must be designed to guard against the risk of polio reemergence due to long-term VDPV excretors, accidental release of wild viruses or bioterrorism. The main strategies under consideration are a surveillance and response approach or a continuation of vaccination with IPV. Choosing between these strategies will pose a major dilemma for India and for many other countries.
    MeSH term(s) Bioterrorism ; Decision Making ; Developing Countries ; Global Health ; Humans ; Immunity, Mucosal ; Poliomyelitis/prevention & control ; Poliovirus ; Poliovirus Vaccines/administration & dosage ; Vaccination/methods
    Chemical Substances Poliovirus Vaccines
    Language English
    Publishing date 2005-02
    Publishing country India
    Document type Journal Article
    ZDB-ID 402594-5
    ISSN 0019-6061
    ISSN 0019-6061
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Recommandations pour la recherche clinique dans les pays en développement.

    Vray, Muriel / Simon, François / Bompart, François

    Therapie

    2007  Volume 62, Issue 3, Page(s) 217–222

    Language French
    Publishing date 2007-05
    Publishing country France
    Document type Journal Article
    ZDB-ID 603474-3
    ISSN 1958-5578 ; 0040-5957
    ISSN (online) 1958-5578
    ISSN 0040-5957
    DOI 10.2515/therapie:2007044
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: Guidelines for Clinical Research in Developing Countries.

    Vray, Muriel / Simon, François / Bompart, François

    Therapie

    2007  Volume 62, Issue 3, Page(s) 223–227

    Abstract: On the basis of a review of current clinical research conditions in developing countries, guidelines have been formulated to ensure scientific validity as well as adherence to universal ethical principles. The main recommendation is that projects should ... ...

    Abstract On the basis of a review of current clinical research conditions in developing countries, guidelines have been formulated to ensure scientific validity as well as adherence to universal ethical principles. The main recommendation is that projects should be reviewed by two Institutional Review Boards, one in the country where the Study Sponsor is based, and another in the country where the study is being carried out. In addition, an independent Data Safety Monitoring Board should be set up and systems established to ensure the effective reporting of Serious Adverse Events and to specify the Sponsor's obligations after the end of the Study.
    Language English
    Publishing date 2007-05
    Publishing country France
    Document type Journal Article
    ZDB-ID 603474-3
    ISSN 1958-5578 ; 0040-5957
    ISSN (online) 1958-5578
    ISSN 0040-5957
    DOI 10.2515/therapie:2007045
    Database MEDical Literature Analysis and Retrieval System OnLINE

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