Abstract
Objective
To analyse users’ experience of TOPS, an internet-based system that helps UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or starting a second trial too soon after the first.
Methods
We sent to all units that currently use TOPS an anonymous questionnaire comprising 18 questions about the effectiveness and ease of use of the system.
Results
Of 35 units that currently use TOPS, 31 (85.7 %) returned questionnaires. Most users find TOPS easy to use, had increased their detection rate of over-volunteering, and had rejected subjects as a result of using TOPS. A GP reply alone is not enough to prevent over-volunteering. Ethics committees, the MHRA and sponsors know about TOPS and support its use.
Conclusions
The results confirm that TOPS does prevent healthy subjects from over-volunteering. Consequently, the Health Research Authority has agreed to take over the management of TOPS. Ethics committee approval of a phase 1 trial and MHRA accreditation of the unit will henceforth be conditional on consistent and proper use of TOPS. That should enhance its effectiveness and improve the safety of volunteers in non-therapeutic trials in the UK.
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References
Stunkel L, Grady C (2011) More than the money: A review of the literature examining healthy volunteer motivations. Contemp Clin Trials 32:342–352
Research on healthy volunteers (1986) A report of the royal college of physicians. J Roy Coll Physicians 20
Guidelines for phase 1 clinical trials (2012) Association of the British pharmaceutical industry
Boyce M, Walther M, Nentwich H, Kirk J, Smith S, Warrington S (2012) TOPS: An internet-based system to prevent healthy subjects from over-volunteering for clinical trials. Eur J Clin Pharmacol 68:1019–1024
Food and Drug Administration (2000) Good clinical practice regulations. Code of Federal Regulations 21 CFR Part 56.110.
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf (last accessed 12 March 2013).
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:pdf (last accessed 12 March 2013).
http://www.surveymonkey.com (last accessed 12 March 2013).
Nuffield Council on Bioethics (2011) Human bodies: Donation for medicine and research. Available at http://www.nuffieldbioethics.org/sites/default/files/Donation_full_report.pdf
Berlin PA (2011) Available at http://www.agah.info/uploads/media/Sessios5_Presentation_A_Peremans_pdf.pdf (last accessed 9 March 2013).
Boyce M, Walther M, Nentwich H, Kirk J, Smith S, Warrington S (2013) TOPS: An internet-based system to prevent healthy subjects from over-volunteering for clinical trials. Eur J Clin Pharmacol 69:71, letter
http://www.dh.gov.uk/health/2011/12/creation-hra/ (last accessed 12 March 2013).
http://www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/con2033097.pdf (last accessed 12 March 2013)
http://www.nres.nhs.uk/nres-publications/news/changes-to-the-review-and-approval-process-for-phase-i-studies/ (last accessed 9 May 2013)
http://www.hra.nhs.uk/hra-news-and-announcements/hra-takes-on-responsibility-for-section-251-review-function-and-tops/ (last accessed 9 May 2013)
Acknowledgements
We thank TOPS users for participating in the survey, and the independent Trustees for their continuing support.
Competing interests
HMR funds TOPS. All authors are employees of HMR. MB and JK are Trustees of TOPS, a registered charity (No.1100989).
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Malcolm James Boyce, Mavi Walther, John Kirk, Stephen Smith and Steven Warrington on behalf of the TOPS Trustees
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Boyce, M., Walther, M., Kirk, J. et al. Survey of users of TOPS, an internet-based system to prevent healthy subjects from over-volunteering for clinical trials. Eur J Clin Pharmacol 69, 1757–1760 (2013). https://doi.org/10.1007/s00228-013-1534-4
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DOI: https://doi.org/10.1007/s00228-013-1534-4