TOPS: an internet-based system to prevent healthy subjects from over-volunteering for clinical trials

Aim Our aim was to set up a system to help UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or from starting a second trial too soon after the first. Methods TOPS (The Over-volunteering Prevention System) is internet-b...

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Bibliographic Details
Published in:European journal of clinical pharmacology 2012-07, Vol.68 (7), p.1019-1024
Main Authors: Boyce, M., Walther, M., Nentwich, H., Kirk, J., Smith, S., Warrington, S.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Biomedical and Life Sciences
Biomedical Research - ethics
Biomedical Research - legislation & jurisprudence
Biomedical Research - organization & administration
Biomedicine
Clinical Trial
Clinical trials
Clinical Trials as Topic - ethics
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - standards
Government Regulation
Humans
Internet
Medical sciences
Nontherapeutic Human Experimentation - ethics
Nontherapeutic Human Experimentation - legislation & jurisprudence
Nontherapeutic Human Experimentation - standards
Participation
Pharmacology. Drug treatments
Pharmacology/Toxicology
Regulation
Research Subjects - legislation & jurisprudence
United Kingdom
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Summary:Aim Our aim was to set up a system to help UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or from starting a second trial too soon after the first. Methods TOPS (The Over-volunteering Prevention System) is internet-based, simple and quick to use, free to users and a charity run by a Board of Trustees. Users enter only two or three pieces of information: (1) ‘National Insurance number’ (NINO) of UK citizens, or ‘passport number’ and country of origin of non-UK citizens, as their identifier, (2) ‘date of last dose’ of trial medicine or (3) ‘never dosed’. Subjects must consent, but TOPS collects only non-personal data, so it does not require Ethics Committee approval and is not covered by the Data Protection Act. Results A total of 55 research units (29 clinical research organisations, 5 pharmaceutical companies, 13 universities and 8 hospitals) throughout the UK have registered to use TOPS, and have entered 124,906 volunteers since we launched it. All commercial and many non-commercial units now use TOPS. In our unit, no subject has to the best of our knowledge participated in two trials simultaneously. TOPS has reduced to
ISSN:0031-6970
1432-1041
DOI:10.1007/s00228-012-1231-8