Hammersmith Medicines Research HMR

London, United Kingdom

Hammersmith Medicines Research HMR

London, United Kingdom
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Boyce M.,Hammersmith Medicines Research HMR | Walther M.,Hammersmith Medicines Research HMR | Kirk J.,Hammersmith Medicines Research HMR | Smith S.,Hammersmith Medicines Research HMR | Warrington S.,Hammersmith Medicines Research HMR
European Journal of Clinical Pharmacology | Year: 2013

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. © 2013 Springer-Verlag Berlin Heidelberg.


Boyce M.,Hammersmith Medicines Research HMR | Walther M.,Hammersmith Medicines Research HMR | Nentwich H.,Hammersmith Medicines Research HMR | Kirk J.,Hammersmith Medicines Research HMR | And 2 more authors.
European Journal of Clinical Pharmacology | Year: 2012

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. © The Author(s) 2012.


PubMed | Hammersmith Medicines Research HMR
Type: Journal Article | Journal: European journal of clinical pharmacology | Year: 2013

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.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.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.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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