Renewal of the Network of Hubs for Trials Methodology Research.

更新试验方法学研究中心网络。

• 批准号: MR/L004933/1
• 负责人: Mahesh Parmar
• 金额: $ 430.81万
• 依托单位: University College London
• 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%2FL004933%2F1
• 关键词: Renewal; Network; Hubs; Trials; Methodology

With the rising demands on the resources available for health care, it is increasingly important that decision makers, including practitioners, patients, policy makers and the public, have access to reliable and robust information about the relative effects of different interventions they might choose between. This information primarily comes from clinical trials which compared the interventions, and trials themselves need to be conducted in ways that are efficient and effective. In 2009, the MRC established the Hubs for Trials Methodology Research to conduct research to achieve this, and to facilitate the implementation of the findings of this research into practice in trials. A Network was created to add value to the work of the individual Hubs and this proposal seeks to renew the work of the Network for five more years and to extend the work to include a programme of training that will build capacity in methodology research for the future. This will be achieved by a unique programme of PhD studentships in trial methodology, which will create new experts in this area.The Hubs provide a UK-wide, regionally distributed research resource to improve the design, conduct, analysis, interpretation, and reporting of clinical trials. The Network links the Hubs to enhance their individual activities, strengthen the methodological research further, and improve dissemination and education relating to good methods in clinical trials. The Network provides funds for high priority research to answer specific issues around trials; conducts workshops to develop methods and train people involved in trials; organises a large international conference every two years to bring researchers together to share their current research and learn from each other; and, will establish and implement a new programme for PhD students to train as methodologists within a national programme of methodology research.The Network helps the Hubs to work with many people and organisations who are key to clinical trials in the UK and internationally. These include those who fund trials, such as the National Institute for Health Research and major charities including Cancer Research UK, Arthritis UK and the British Heart Foundation; those who organise trials, including the pharmaceutical industry and universities; the groups that support them, including the UK-registered Clinical Trials Units, Research Design Services and Contract Research Organisations in the private sector; as well as the users of health care and individuals who run trials in academia, practice and industry. Under this proposal, the Network will continue with its four main objectives and add a fifth relating to the PhD studentships. These objectives are:a) Promoting high quality collaborative methodological research, both across Hubs and with other groups, UK-wide and internationally.b) Providing methodological advice to the clinical trials community.c) Encouraging the implementation of the most effective and appropriate methodological practice, for example by providing a coordinated package of education and training. d) Working with external stakeholders, in particular to agree on shared priorities for research and guidance.e) Capacity building of training in the UK by supporting a cohort of clinical and non-clinical PhD students in methodology.The coordination of this studentship programme by the Network will:> Create a cadre of scientists, including clinicians, with skills that will place them at the forefront of trials methodology development.> Align the PhD studentships with the Network's strategic aims and research priorities, while reflecting the priorities of the Hub in which the student is based.> Offer students unique inter-disciplinary and diverse analytical and technical skill training.> Develop and sustain a vibrant postgraduate student culture in the Network.> Raise the profile of the studentship programme, to attract outstanding candidates.

随着对现有保健资源的需求不断增加，决策者，包括从业人员、病人、决策者和公众，能够获得关于他们可能选择的不同干预措施的相对效果的可靠和有力的信息，这一点越来越重要。这些信息主要来自比较干预措施的临床试验，试验本身需要以高效和有效的方式进行。2009年，MRC建立了试验方法研究中心，以开展研究以实现这一目标，并促进将研究结果应用于试验实践。建立了一个网络，以增加各个中心的工作价值，本建议力求将该网络的工作再延长五年，并扩大工作范围，包括一个培训方案，为今后建立方法研究的能力。这将通过一个独特的试验方法学博士学位项目来实现，这将在这一领域创造新的专家。这些中心提供了全英国范围内、区域分布的研究资源，以改进临床试验的设计、实施、分析、解释和报告。该网络将各中心联系起来，以加强其个别活动，进一步加强方法学研究，并改进与临床试验中良好方法有关的传播和教育。该网络为高优先级研究提供资金，以回答有关试验的具体问题；举办讲习班以发展方法并培训参与试验的人员；每两年组织一次大型国际会议，将研究人员聚集在一起，分享他们当前的研究并相互学习；并且，将建立和实施一个新的项目，让博士生在一个国家方法学研究项目中成为方法学家。该网络帮助中心与许多对英国和国际临床试验至关重要的人员和组织合作。这些机构包括为试验提供资金的机构，如国家健康研究所和主要慈善机构，如英国癌症研究所、英国关节炎协会和英国心脏基金会；那些组织试验的人，包括制药行业和大学；支持他们的团体，包括在英国注册的临床试验单位、研究设计服务和私营部门的合同研究组织；以及医疗保健的使用者和在学术界、实践和工业中进行试验的个人。根据这项建议，该网络将继续其四个主要目标，并增加第五个与博士研究生有关的目标。这些目标是：a)促进高质量的合作方法研究，无论是跨中心还是与英国范围内和国际上的其他小组。b)向临床试验界提供方法学建议。c)鼓励实施最有效和最适当的方法学实践，例如提供一整套协调一致的教育和培训。d)与外部利益相关者合作，特别是就研究和指导的共同优先事项达成一致。e)通过支持一批临床和非临床方法学博士生，在英国开展培训能力建设。该网络对这一学生项目的协调将：>创建一个科学家骨干，包括临床医生，他们的技能将使他们处于试验方法发展的前沿。b>使博士生与网络的战略目标和研究重点保持一致，同时反映学生所在中心的优先事项。b>为学生提供独特的跨学科和多样化的分析和技术技能培训。>在网络中发展和维持充满活力的研究生文化。b>提高学生计划的知名度，吸引优秀的候选人。

项目成果

Biomarker-guided trials: Challenges in practice.

生物标志物引导的试验：实践中的挑战。

• DOI: 10.17863/cam.46709
• 发表时间: 2019
• 作者: Antoniou M

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

Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial.

• DOI: 10.1186/s13063-018-2500-3
• 发表时间: 2018-02-22
• 期刊: Trials
• 影响因子: 2.5
• 作者: Baos S;Brigden A;Anderson E;Hollingworth W;Price S;Mills N;Beasant L;Gaunt D;Garfield K;Metcalfe C;Parslow R;Downing H;Kessler D;Macleod J;Stallard P;Knoop H;Van de Putte E;Nijhof S;Bleijenberg G;Crawley E
• 通讯作者: Crawley E