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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: 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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  2. Content type: Study protocol

    Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as me...

    Authors: Youme Ko, Seung-Ho Sun, In-Sik Han, Ho-Yeon Go, Tae-Hun Kim, Jin-Moo Lee, Jun-Bok Jang, Kyoung Sun Park, Yun-Kyung Song, Kyou-Young Lee, Chan-Yong Jeon and Seong-Gyu Ko

    Citation: Trials 2019 20:217

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  3. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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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