MRC North West Hub for Trials Methodology Research

MRC 西北试验方法研究中心

• 批准号: MR/K025635/1
• 负责人: Paula Williamson
• 金额: $ 295.75万
• 依托单位: University of Liverpool
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FK025635%2F1
• 关键词: MRC; North; West; Hub; Trials

The Medical Research Council funded North West Hub for Trials Methodology Research (NWHTMR) is a collaboration which brings together experts in clinical trials research from the Universities of Liverpool, Lancaster, Bangor and Manchester. Clinical trials are studies conducted in patients to evaluate the potential benefits (and risks) that new treatments could offer. They provide the 'gold standard' evidence base for informing and improving future patient care. The Hub has experts in medical statistics, clinical trials methods, pharmacoeconomics (drugs are compared for their value), sociology and clinical psychology. The Mission of the Hub is to create a world-class centre where methods used in clinical trials can be investigated. The overall aim is to improve patient care by making sure we test, use and develop the best methods possible for clinical trials. This will help to make sure that research studies are relevant and correctly measuring what we want to measure. The Hub also works in collaboration with patients and service users to make sure their experiences of clinical trials and health conditions are included in developing better methods for carrying out clinical trials. Together we are committed to making sure that the best methods possible to design, run and analyse clinical trials are researched, developed, used and further evaluated. The Hub focuses on four themes:- Early phase trial design and analysis, (when drugs are first researched to check for their safety and to see what effect they have)- Later phase trial design and analysis and (when drugs are checked to see how well they work in routine care)- Patients' perspectives, (what patients' experiences of taking part in clinical trials are)- Efficacy and mechanism evaluation of targeted therapies (choosing the right drug or drug dose to give to a patient, sometimes referred to as 'personalised medicine')We want to make sure that we develop good methods that can be used in key clinical areas and we have a particular interest in drug safety, medicines for children, mental health, epilepsy, cancer, surgical trials and infection.The major aims of the Hub are to:- Provide a world-class environment for carrying out research that will improve the design, conduct and analysis of clinical trials; - Make sure that our findings are used to improve the methods used in future clinical trials. - Set up training programmes to develop the next generation of clinical trial experts.- Work in partnership with others, both in the public sector and industry.The key objectives are to: - Improve the design, conduct, analysis and reporting of clinical trials; - Develop a methodological research portfolio generated by a broad team of investigators from a range of disciplines; - Build on considerable local Cochrane expertise to improve the integration between trials and systematic reviews in relation to trial design and reporting; - Use local strengths in pharmacology (the study of drugs) to improve the design of drug clinical trials; - Train the next generation of clinical trials experts; - Work well with industry in developing good clinical trials; - Publicise the work that we have done. Key achievements to date include:- The COMET (Core Outcome Measures in Effectiveness Trials) Initiative (www.comet-initiative.org) - this project works with international experts and patients interested in the development and application of agreed standardised sets of outcomes, known as 'core outcome sets'.- The Database of Instruments for Resource Use Measurement (DIRUM www.dirum.org), (A bank of tested questionnaires for use by health economists)- A network meeting "Improving accrual and recruitment conduct in clinical trials with children and other patients unable to consent for themselves" (http://www.liv.ac.uk/nwhtmr/events/past_events/recruit_meeting.htm.Further details are available at http://www.liv.ac.uk/nwhtmr.

医学研究理事会资助的西北试验方法研究中心（NWHTMR）是一个合作项目，汇集了来自利物浦、兰开斯特、班戈尔和曼彻斯特大学的临床试验研究专家。临床试验是在患者中进行的研究，以评估新疗法可能提供的潜在益处（和风险）。它们为告知和改善未来的患者护理提供了“黄金标准”证据基础。该中心拥有医学统计学，临床试验方法，药物经济学（药物的价值比较），社会学和临床心理学方面的专家。该中心的使命是创建一个世界级的中心，在那里可以研究临床试验中使用的方法。我们的总体目标是通过确保我们测试，使用和开发临床试验的最佳方法来改善患者护理。这将有助于确保研究是相关的，并正确地衡量我们想要衡量的东西。该中心还与患者和服务用户合作，以确保他们的临床试验和健康状况的经验包括在开发更好的方法进行临床试验。我们共同致力于确保研究、开发、使用和进一步评估设计、运行和分析临床试验的最佳方法。该中心侧重于四个主题：- 早期试验设计和分析，（当药物首次研究以检查其安全性并查看其效果时）-后期试验设计和分析，（当检查药物以查看它们在常规护理中的效果如何时）-患者的观点，（患者参加临床试验的经历）-靶向治疗的疗效和机制评价（选择正确的药物或药物剂量给病人，有时被称为“个性化药物”）我们希望确保我们开发出可用于关键临床领域的良好方法，我们对药物安全，儿童药物，精神健康，癫痫，癌症，该中心的主要目标是：-为开展研究提供世界一流的环境，以改善临床试验的设计，实施和分析; -确保我们的研究结果用于改善未来临床试验中使用的方法。- 建立培训计划，培养下一代临床试验专家。与公共部门和工业界的其他人建立伙伴关系，主要目标是：-改进临床试验的设计、实施、分析和报告; -开发由来自一系列学科的广泛研究人员团队产生的方法学研究组合;-在相当多的本地科克伦专业知识的基础上，改善试验设计和系统评价之间的整合，报告;- 利用本地在药理学（药物研究）方面的优势，改善药物临床试验的设计; -培训下一代临床试验专家; -与业界合作，发展良好的临床试验; -宣传我们所做的工作。迄今为止的主要成就包括：-COMET（有效性试验中的核心结果指标）倡议（www.comet-initiative.org）-该项目与国际专家和对开发和应用商定的标准化结果集（称为“核心结果集”）感兴趣的患者合作。资源使用测量工具数据库（DIRUM www.dirum.org），（供卫生经济学家使用的经过测试的问卷库）-一次网络会议，“改善儿童和其他无法自行同意的患者的临床试验中的应计和招募行为”（http：www.liv.ac.uk/nwhtmr/events/past_events/recruit_meeting.htm.Further），详情见http://www.liv.ac.uk/nwhtmr。

项目成果

Biomarker-guided trials: Challenges in practice

• DOI: 10.1016/j.conctc.2019.100493
• 发表时间: 2019-12-01
• 期刊: CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS
• 影响因子: 1.5
• 作者: Antoniou, M.;Kolamunnage-Dona, R.;Jorgensen, A. L.
• 通讯作者: Jorgensen, A. L.

Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

• DOI: 10.1371/journal.pone.0149803
• 发表时间: 2016
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Antoniou M;Jorgensen AL;Kolamunnage-Dona R
• 通讯作者: Kolamunnage-Dona R

Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies.

• DOI: 10.1136/bmjopen-2016-013537
• 发表时间: 2017-02-17
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Avery KN;Williamson PR;Gamble C;O'Connell Francischetto E;Metcalfe C;Davidson P;Williams H;Blazeby JM;members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research
• 通讯作者: members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research

Citation analysis did not provide a reliable assessment of core outcome set uptake.

• DOI: 10.1016/j.jclinepi.2017.03.003
• 发表时间: 2017-06
• 期刊: Journal of clinical epidemiology
• 影响因子: 7.2
• 作者: Barnes KL;Kirkham JJ;Clarke M;Williamson PR
• 通讯作者: Williamson PR

A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress.

用于有意义且灵活地参与临床试验的患者和公众参与 (PPI) 工具包 - 一项正在进行的工作。

• DOI: 10.1186/s40900-016-0029-8
• 发表时间: 2016
• 期刊: Research involvement and engagement
• 作者: Bagley HJ;Short H;Harman NL;Hickey HR;Gamble CL;Woolfall K;Young B;Williamson PR
• 通讯作者: Williamson PR