Edwards Rhiannon T, Hounsome Barry, Linck Pat, Russell Ian T
Centre for Economics and Policy in Health, Institute of Medical and Social Care Research, Bangor University, Dean Street, Bangor, UK.
Trials. 2008 Nov 17;9:64. doi: 10.1186/1745-6215-9-64.
There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials.
A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis.
Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP.
We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.
人们普遍认识到，实用性随机试验是进行经济评估的最佳方式。这是因为试验提供了确保内部有效性的最佳机会，尤其是通过严格前瞻性收集特定患者数据。此外，在收集临床数据的同时收集经济数据的边际成本通常较低。英国临床研究协作组（UKCRC）并不要求将经济评估的标准操作程序（SOP）作为试验单位注册的先决条件。我们认为这样的SOP有助于将卫生经济学纳入试验。
班戈大学的卫生经济学家和试验人员合作，除了UKCRC注册所需的20个SOP（包括随机化、数据管理和统计分析）之外，还制定了一个与实用性试验一起进行经济评估的SOP。
我们最近的电话调查表明，目前没有其他UKCRC注册的试验单位拥有经济SOP。
我们认为，UKCRC应该要求所有进行经济评估并寻求注册或重新注册的试验单位，将经济评估的SOP作为其支持性SOP组合之一。
