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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. This randomized controlled clinical trial aims to evaluate the efficacy and safety of opposing needling in patients undergoing unilateral total knee arthroplasty (TKA). Opposing needling is one of the special ...

    Authors: Hai Huang, Xiuling Song, Ling Zhao, Lin Zheng, Lianbo Xiao and Yuelai Chen
    Citation: Trials 2020 21:385
  2. Ischemic cardiomyopathy and severe left ventricular dysfunction are well established to represent the main determinants of poor survival and premature death compared with preserved ventricular function. Howeve...

    Authors: Paulo Cury Rezende, Whady Hueb, Edimar Alcides Bocchi, Michael Farkouh, Carlos Vicente Serrano Junior, Eduardo Gomes Lima, Expedito Eustáquio Ribeiro Silva, Luis Alberto Oliveira Dallan, Fabio Antonio Gaiotto, Cibele Larrosa Garzillo, Carlos Eduardo Rochitte, Cesar Higa Nomura, Thiago Luis Scudeler, Paulo Rogério Soares, Fabio Biscegli Jatene, José Antonio Franchini Ramires…
    Citation: Trials 2020 21:337
  3. Data from meta-analysis suggest that robotic radical antegrade modular pancreatosplenectomy (RAMPS) is a safe and effective procedure for treating adenocarcinoma in the body or tail of the pancreas, and is onc...

    Authors: Gong Zhang, Yuhao Kang, Haifeng Zhang, Fei Wang and Rong Liu
    Citation: Trials 2020 21:306
  4. Temporary fixation with an external fixator is used for numerous indications in orthopedic trauma surgery. It is unclear whether primary wound healing or secondary open-wound healing after removal of the exter...

    Authors: Franz Roth, Flavio Cagienard, Björn C. Link, Sandro Hodel, Dirk Lehnick, Reto Babst and Frank J. P. Beeres
    Citation: Trials 2020 21:205
  5. Coronary microvascular disease (CMVD) can be described as one of the cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculatory lesions, often presenting a...

    Authors: Zhuang Jieqin, Liu Shuling, Cai Hairong, Dai Xingzhen, Chen Yanhong, Jin Zilin and Chen Bojun
    Citation: Trials 2020 21:75
  6. Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhiniti...

    Authors: Jeevani Maheshika Dahanayake, Pathirage Kamal Perera, Priyadarshani Galappaththy and Dulani Samaranayake
    Citation: Trials 2020 21:37
  7. Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to in...

    Authors: Wen-ting Chen, Jin-feng Wei, Lan Wang, Deng-wen Zhang, Wei Tang, Jian Wang, Yue Yong, Jing Wang, Ya-lan Zhou, Lan Yuan, Guo-qiang Fu, Sheng Wang and Jian-gang Song
    Citation: Trials 2019 20:789
  8. The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they nega...

    Authors: Hailong Zhang, Jiansheng Li, Xueqing Yu, Suyun Li, Haifeng Wang, Huanrong Ruan, Yimei Si, Yang Xie and Minghang Wang
    Citation: Trials 2019 20:735
  9. Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits ...

    Authors: Yuqin Chen, Wenjun He, Haiping Ouyang, Chunli Liu, Cheng Hong, Tao Wang, Kai Yang, Wenju Lu and Jian Wang
    Citation: Trials 2019 20:725

    The Correction to this article has been published in Trials 2020 21:296

  10. Due to the large number of patients, high mortality rate as well as high social costs and economic burden, chronic obstructive pulmonary disease (COPD) has become one of the most important health problems arou...

    Authors: Yaqi Zu, Demin Li, Xiang Lei and Hongchun Zhang
    Citation: Trials 2019 20:647
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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

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

  16. 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

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

  17. 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
  18. 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
  19. 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
  20. 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
  21. 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
  22. 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
  23. 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
  24. 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