Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine.
Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine.
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DOI：
10.1186/1475-2875-10-223
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发表时间：
2011-08-04
期刊：
影响因子：
3
通讯作者：
Clinical Trials Partnership Committee
中科院分区：
文献类型：
--
作者：
Swysen C;Vekemans J;Bruls M;Oyakhirome S;Drakeley C;Kremsner P;Greenwood B;Ofori-Anyinam O;Okech B;Villafana T;Carter T;Savarese B;Duse A;Reijman A;Ingram C;Frean J;Ogutu B;Clinical Trials Partnership Committee
RTS，S/AS 01疟疾候选疫苗的关键性第三阶段研究正在非洲的几个研究中心进行。开发和建立质量体系是开展试验以达到国际监管标准的一项要求，同时也为研究中心提供了一个重要的加强能力的机会。在供资伙伴的协助下，每个研究中心都采用了标准化的实验室方法和质量保证程序。根据世界卫生组织的建议，建立了一个基于实际血细胞计数确定寄生虫密度的稳健方案。配备了包括血液学和生化分析仪在内的自动化设备，并采用标准方法对高血糖、碱过量和乳酸血症进行床边检测。在一些中心，除了保健基础设施外，还提供或更新了X光和基本微生物检测设施。建立了所有主要实验室方法的外部质量保证评估，并证明了每个实验室的方法确认。由此加强的能力确保了在当地按照临床试验所需的高标准进行实验室评价。研究中心的重大努力，加上合作方的支持，使得RTS，S/AS 01疟疾候选疫苗的第三阶段评价的标准化方法和强有力的质量保证程序得以落实。广泛的培训方案，加上研究中心工作人员的持续承诺，是成功实施质量流程的关键因素。预计这些活动将最终为参与这些试验的受试者和社区带来医疗保健益处。Clinicaltrials.gov NCT00866619
A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres. Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners. A robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials. Major efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials. Clinicaltrials.gov NCT00866619
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DOI：
10.4269/ajtmh.2001.65.599
发表时间：
2001-11-01
影响因子：
3.3
作者：
Planche, T;Krishna, S;Kremsner, PG
通讯作者：
Kremsner, PG
影响因子：
168.9
作者：
Alonso, PL;Sacarlal, J;Ballou, WR
通讯作者：
Ballou, WR
影响因子：
6.4
作者：
Sacarlal, Jahit;Aide, Pedro;Alonso, Pedro L.
通讯作者：
Alonso, Pedro L.
影响因子：
158.5
作者：
Abdulla, Salim;Oberholzer, Rolf;Tanner, Marcel
通讯作者：
Tanner, Marcel
影响因子：
168.9
作者：
Aponte, John J.;Aide, Pedro;Alonso, Pedro L.
通讯作者：
Alonso, Pedro L.