Post-trial responsibilities beyond post-trial access

Before regulatory approval, all participants regardless of access to heatlh care have equal need for an investigational treatment (if indicated), and neither group has post-trial access without external provision. Simply transitioning an insured participant to the extant health-care system might dis...

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Bibliographic Details
Published inThe Lancet (British edition) Vol. 391; no. 10129; pp. 1478 - 1479
Main Authors Cho, Hae Lin, Danis, Marion, Grady, Christine
Format Journal Article
LanguageEnglish
Published England Elsevier Ltd 14.04.2018
Elsevier Limited
Subjects
Clinical Trials as Topic - ethics
Continuity of Patient Care - ethics
Ethics
Ethics, Research
Health care
Health care access
Health Services Accessibility - ethics
Humans
Pharmaceutical Preparations - supply & distribution
Regulatory approval
Research Subjects
Social services
Uninsured people
United States > US
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Summary:Before regulatory approval, all participants regardless of access to heatlh care have equal need for an investigational treatment (if indicated), and neither group has post-trial access without external provision. Simply transitioning an insured participant to the extant health-care system might discharge an investigator's obligation, because the participant will probably receive comparable or adequate care; this transition is insufficient for uninsured participants with poor access to health care and disregards their safety. Investigators and sponsors might need to help arrange additional post-trial care, including financial support, medical care, or social services, to bridge this gap.
Bibliography:SourceType-Scholarly Journals-1
ObjectType-Correspondence-1
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ISSN:0140-6736
1474-547X
1474-547X
DOI:10.1016/S0140-6736(18)30761-X