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

• Published in: European journal of clinical pharmacology Vol. 68; no. 7; pp. 1019 - 1024
• Main Authors: Boyce, M., Walther, M., Nentwich, H., Kirk, J., Smith, S., Warrington, S.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.07.2012; Springer; Springer Nature B.V
• 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; United Kingdom > UK; TOPS; Healthy volunteers; Over-volunteering; Phase 1 trials; Human; Prevention; Healthy subject; Phase I trial; Clinical trial; Internet
• ISSN: 0031-6970; 1432-1041; 1432-1041
• DOI: 10.1007/s00228-012-1231-8

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 <1% the incidence of subjects attempting to volunteer within 3 months of completing another trial elsewhere, and very few have to our knowledge succeeded. Conclusion TOPS is widely used and effective, and helps research units to comply with UK clinical trial regulations.