Hammersmith Medicines Research (HMR), Cumberland Avenue, London, NW10 7EW, UK,
Eur J Clin Pharmacol. 2013 Oct;69(10):1757-60. doi: 10.1007/s00228-013-1534-4. Epub 2013 Jun 7.
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.
分析基于互联网的 TOPS 系统的用户体验，该系统有助于英国临床研究机构防止健康志愿者同时参与多项非治疗性试验，或在首次试验后过快地开始第二项试验。
我们向所有目前使用 TOPS 的单位发送了一份匿名问卷，其中包含 18 个关于该系统的有效性和易用性的问题。
在 35 个目前使用 TOPS 的单位中，有 31 个（85.7%）返回了问卷。大多数用户认为 TOPS 使用方便，提高了他们对过度招募的检测率，并因使用 TOPS 而拒绝了受试者。仅仅是全科医生的回复是不够的，无法防止过度招募。伦理委员会、药品和保健品管理局（MHRA）和赞助商都知道 TOPS 的存在，并支持其使用。
结果证实 TOPS 确实可以防止健康受试者过度参与。因此，健康研究管理局已同意接管 TOPS 的管理。今后，伦理委员会对 1 期试验的批准和 MHRA 对单位的认证将取决于 TOPS 的一致和正确使用。这应该提高其有效性，并提高英国非治疗性试验中志愿者的安全性。
