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Building capacity for evidence informed trial management

Edited by: Dr Roberta Littleford and Prof Shaun Treweek

A thematic series published in Trials.

This series includes articles that report on what is currently known about effective trial management processes, how confident we are in that information and what we should all be doing to make trial management more evidence-informed and more widely discussed in the literature.

The deadline for submissions to this thematic series was 30 September 2018. Further articles will be added in due course following peer review.

  1. Content type: Study protocol

    Numerous randomized trials involving acupuncture treatment for cervicogenic headache (CEH) have been conducted in recent years, but the evidence for its effectiveness is not clear. Hence, we designed a randomi...

    Authors: Youkang Dong, Taipin Guo, Lei Xu, Chunlin Wang, Guanfen Wen, Zhiyong Zhao, Lianhai Duan, Mei Zou, Yong Xiang and Shu Wang

    Citation: Trials 2019 20:418

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  2. Content type: Commentary

    Expert trial managers with the training and experience to overcome operational challenges are often the difference between the success and failure of a clinical trial. Considerable importance is given to the b...

    Authors: Danielle Beaumont, Monica Arribas, Lauren Frimley, Eni Balogun, Ian Roberts and Haleema Shakur-Still

    Citation: Trials 2019 20:354

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  3. Content type: Study protocol

    Chronic urticaria (CU) is a refractory skin disease with long duration and a high recurrence rate. Acupuncture has been widely used for the treatment of CU in clinical practice in China. However, until now, th...

    Authors: Yunzhou Shi, Hui Zheng, Siyuan Zhou, Qianhua Zheng, Leixiao Zhang, Xianjun Xiao, Wei Cao, Ying Liu and Ying Li

    Citation: Trials 2019 20:326

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  4. Content type: Research

    Improving efficiencies in clinical research is crucial to translation of findings into practice and delivery of effective, patient-centered health care. This paper describes a project that monitored pragmatic ...

    Authors: Paula Darby Lipman, Leanora Dluzak and Catherine M. Stoney

    Citation: Trials 2019 20:307

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  5. Content type: Methodology

    There is limited research and literature on the data management challenges encountered in multi-arm, multi-stage platform and umbrella protocols. These trial designs allow both (1) seamless addition of new res...

    Authors: Dominic Hague, Stephen Townsend, Lindsey Masters, Mary Rauchenberger, Nadine Van Looy, Carlos Diaz-Montana, Melissa Gannon, Nicholas James, Tim Maughan, Mahesh K. B. Parmar, Louise Brown and Matthew R. Sydes

    Citation: Trials 2019 20:294

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    The Methodology to this article has been published in Trials 2019 20:264

  6. Content type: Methodology

    There are limited research and literature on the trial management challenges encountered in running adaptive platform trials. This trial design allows both (1) the seamless addition of new research comparisons...

    Authors: Francesca Schiavone, Riya Bathia, Krishna Letchemanan, Lindsey Masters, Claire Amos, Anna Bara, Louise Brown, Clare Gilson, Cheryl Pugh, Nafisah Atako, Fleur Hudson, Mahesh Parmar, Ruth Langley, Richard S. Kaplan, Chris Parker, Gert Attard…

    Citation: Trials 2019 20:264

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    The Methodology to this article has been published in Trials 2019 20:294

  7. Content type: Methodology

    Monitoring and managing data returns in multi-centre randomised controlled trials is an important aspect of trial management. Maintaining consistently high data return rates has various benefits for trials, in...

    Authors: William J. Cragg, Fay Cafferty, Carlos Diaz-Montana, Elizabeth C. James, Johnathan Joffe, Monica Mascarenhas and Victoria Yorke-Edwards

    Citation: Trials 2019 20:241

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  8. Content type: Methodology

    Triggered monitoring in clinical trials is a risk-based monitoring approach where triggers (centrally monitored, predefined key risk and performance indicators) drive the extent, timing, and frequency of monit...

    Authors: Carlos Diaz-Montana, William J. Cragg, Rahela Choudhury, Nicola Joffe, Matthew R. Sydes and Sally P. Stenning

    Citation: Trials 2019 20:227

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  9. Content type: Methodology

    Recruitment to trials can be difficult. Despite careful planning and research that outlines ways to improve recruitment, many trials do not achieve their target on time and require extensions of funding or time.

    Authors: W. Bertram, A. Moore, V. Wylde and R. Gooberman-Hill

    Citation: Trials 2019 20:207

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  10. Content type: Methodology

    Multicentre randomised trials provide some of the key evidence underpinning healthcare practice around the world. They are also hard work and generally expensive. Some of this work and expense are devoted to s...

    Authors: Hanne Bruhn, Shaun Treweek, Anne Duncan, Kirsty Shearer, Sarah Cameron, Karen Campbell, Karen Innes, Dawn McRae and Seonaidh C. Cotton

    Citation: Trials 2019 20:192

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  11. Content type: Research

    Large multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collec...

    Authors: Kate F. Walker, Julie Turzanski, Diane Whitham, Alan Montgomery and Lelia Duley

    Citation: Trials 2018 19:562

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  12. Content type: Research

    Site performance is key to the success of large multicentre randomised trials. A standardised set of clear and accessible summaries of site performance could facilitate the timely identification and resolution...

    Authors: Diane Whitham, Julie Turzanski, Lucy Bradshaw, Mike Clarke, Lucy Culliford, Lelia Duley, Lisa Shaw, Zoe Skea, Shaun P. Treweek, Kate Walker, Paula R. Williamson and Alan A. Montgomery

    Citation: Trials 2018 19:557

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  13. Content type: Review

    Trials in rare diseases have many challenges, among which are the need to set up multiple sites in different countries to achieve recruitment targets and the divergent landscape of clinical trial regulations i...

    Authors: Rebecca A. Crow, Kimberly A. Hart, Michael P. McDermott, Rabi Tawil, William B. Martens, Barbara E. Herr, Elaine McColl, Jennifer Wilkinson, Janbernd Kirschner, Wendy M. King, Michele Eagle, Mary W. Brown, Deborah Hirtz, Hanns Lochmuller, Volker Straub, Emma Ciafaloni…

    Citation: Trials 2018 19:291

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  14. Content type: Research

    The UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Units (CTUs) Network aims to support high-quality, efficient and sustainable clinical trials research in the UK. To better understand t...

    Authors: Lelia Duley, Alexa Gillman, Marian Duggan, Stephanie Belson, Jill Knox, Alison McDonald, Charlotte Rawcliffe, Joanne Simon, Tim Sprosen, Jude Watson and Wendy Wood

    Citation: Trials 2018 19:15

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