关于儿科临床试验成本计算和估算的联合建议。

Q1 Medicine GMS German Medical Science Pub Date : 2024-04-24 eCollection Date: 2024-01-01 DOI:10.3205/000330
Gabriele Ahne, Julia Nagel, Axel R Franz, Antje Neubert, Kristina Schachtrup, Simone Helms, Sebastian Klammt, Matthias Schwab
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引用次数: 0

摘要

儿科临床试验对于改善儿童药物治疗至关重要。在欧洲,儿科临床试验自 2007 年以来一直得到《欧洲儿科条例》的支持,但对高质量临床试验的需求仍然很大。与观察性研究等其他研究相比,根据欧盟第 536/2014 号和第 745/2017 号法规开展临床试验所需的人员和时间要高得多。重要的是,试验中心的额外工作量应得到充分补偿,同时还要考虑到欧盟的国家援助规则。在儿科试验中,有必要在计算额外费用时考虑到儿科和青少年医学的特殊要求。在泛欧儿科研究网络 c4c/GermanNetPaeT 的框架内,一个工作组负责处理成本计算的具体问题,以支持儿科研究中心进行内部成本计算,以及随后为工业赞助商或公共资助者准备融资要求。在几次研讨会上,工作组开发了一个成本计算模板,其内容来自德国大学医学会(DHM)、临床试验协调中心网络(KKS 网络)和德国研究型制药公司协会(vfa)的 "关于将总服务账目作为简化合同因素的联合建议"。通过估算作为样本研究一部分的措施和调查所需的具体时间,讨论了所需时间增加的背景,并与研究中心一起编制了一份清单,列出了计算成本时需要考虑的各个方面。详细介绍儿科的具体情况,是为了让人们进一步了解儿童和青少年临床试验费用较高这一特殊问题,以及相应的适当报酬的必要性。以透明、易懂的方式介绍对研究中心和资助方的较高财务要求,旨在促进儿科研究中心长期高质量地开展临床试验。
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Joint recommendations on cost calculation and estimation in paediatric clinical trials.

The conduct of clinical trials in paediatrics is essential to improve drug therapy in children. In Europe, paediatric clinical trials have been supported by the European Paediatric Regulation since 2007, but there is still a great need for high-quality clinical trials. The personnel and time required to conduct clinical trials in accordance with EU Regulations 536/2014 and 745/2017 is considerably higher compared to other studies, such as observational studies. It is important that this additional workload for the trial centre is fully compensated, also taking into account EU state aid rules. In paediatric trials, it is necessary to take into account the special requirements of paediatric and adolescent medicine when calculating the additional costs. Within the framework of the pan-European paediatric study network c4c/GermanNetPaeT, a working group dealt with specific aspects of cost calculation in order to support paediatric study centres in internal cost calculation as well as in the subsequent preparation of financing requirements for industrial sponsors or public funders. In several workshops the working group developed a cost calculation template with the content derived from the "Joint recommendations for a total services account as a factor in simplifying contracts" of the Deutsche Hochschulmedizin (DHM, German University Medicine), the Netzwerk der Koordinierungszentren für Klinische Studien (KKS Network, Network of Coordinating Centres for Clinical Trials) and the Verband Forschender Arzneimittelhersteller (vfa, German Association of Research-Based Pharmaceutical Companies). By estimating the specific time required for measures and investigations as part of a sample study, the background to the increased time required was discussed and a list with aspects to be considered for cost calculation was compiled together with the study centres. The paediatrics-specific aspects mentioned in detail are intended to increase understanding of the particular problem of higher costs for clinical trials involving children and adolescents and the need for correspondingly appropriate remuneration. This transparent and comprehensible presentation of the higher financial requirements for both the study centres and the financial supporters is intended to promote the high-quality conduct of clinical trials in paediatric study centres in the long term.

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来源期刊
GMS German Medical Science
GMS German Medical Science Medicine-Medicine (all)
CiteScore
6.30
自引率
0.00%
发文量
10
审稿时长
11 weeks
期刊最新文献
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