Literature DB >> 16817849

After the London tragedy, is it still possible to consider Phase I is safe?

Michel Sibille, Yves Donazzolo, Franck Lecoz, Emmanuel Krupka.   

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Year:  2006        PMID： 16817849      PMCID： PMC1885163          DOI： 10.1111/j.1365-2125.2006.02740.x

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN： 0306-5251            Impact factor:   4.335


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2.  Adverse event associated with methionine loading test: a case report.

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3.  Inquiry into adverse events in trial blames drug, not study design.

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4.  Adverse events in phase-I studies: a report in 1015 healthy volunteers.

Authors:  M Sibille; N Deigat; A Janin; S Kirkesseli; D V Durand
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1.  A safety grading scale to support dose escalation and define stopping rules for healthy subject first-entry-into-man studies: some points to consider from the French Club Phase I working group.

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2.  From pharmacology to immunopharmacology.

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3.  The bridging function of clinical pharmacology.

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Review 4.  Giving monoclonal antibodies to healthy volunteers in phase 1 trials: is it safe?

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5.  Clinical pharmacology in everyday clinical care.

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6.  Using "clinical trial diaries" to track patterns of participation for serial healthy volunteers in U.S. phase I studies.

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Review 7.  Risks of phase I research with healthy participants: A systematic review.

Authors:  Rebecca A Johnson; Annette Rid; Ezekiel Emanuel; David Wendler
Journal:  Clin Trials       Date:  2015-09-08       Impact factor: 2.486

8.  Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials.

Authors:  Jill A Fisher
Journal:  Sci Technol Human Values       Date:  2015-03-01

9.  To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials.

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10.  Inadequate dissemination of phase I trials: a retrospective cohort study.

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Journal:  PLoS Med       Date:  2009-02-17       Impact factor: 11.069
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