ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

Citation data:

Regenerative medicine, ISSN: 1746-076X, Vol: 12, Issue: 6, Page: 705-719

Publication Year:
2017
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Readers 6
Mentions 12
News Mentions 9
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Social Media 7
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Citations 3
Citation Indexes 3
PMID:
28721755
DOI:
10.2217/rme-2017-0015
Author(s):
Turner, Leigh
Publisher(s):
Future Medicine Ltd
Tags:
Engineering; Medicine
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article description
Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.