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Call for papers: Big data for randomized trials

Edited by: Dr Lars Hemkens

Trials invites you to submit to our new thematic series, ‘Big data for randomized trials’.

The Editors will consider articles that report on what is currently known about using big data or routinely collected data (such as electronic health records, registries or administrative databases) for randomized trials, the promises and limitations of using such data sources for trials and how we could make best use of them to improve clinical trial research for better patient care. 

We encourage articles on any topic relevant to big data for conducting randomized trials on any level of health care. This includes articles describing the current knowledge about how using this data may make trials more feasible or would allow exploring research questions otherwise not possible to be explored , or which novel designs would be possible. Topics related to ethical implications, costs, or methodological aspects are very welcome. We are highly interested in empirical research on research studies. Commentaries and opinion pieces are welcome, especially those looking explicitly to practical challenges and offering solutions. All articles should make clear the relevance of using big data for randomized trials and current research gaps, and they should describe how the results or opinions in the article can be used to improve trial design and conduct in the future.

Manuscripts should be formatted according to our submission guidelines and submitted via the online submission system. In the submission system please make sure the correct collection title is chosen from the additional information tab. Please also indicate clearly in the covering letter that the manuscript is to be considered in the ‘Big data for randomized trials’ series.

For further information, please use the contact us email on the journal website.

  1. More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer....

    Authors: Xiao-Lin Wei, Ru-Zhen Yuan, Yong-Mei Jin, Shu Li, Ming-Yue Wang, Jie-Ting Jiang, Cai-Qin Wu and Kun-Peng Li

    Citation: Trials 2021 22:405

    Content type: Study protocol

    Published on:

  2. The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript ...

    Authors: Sophie Relph, Maria Elstad, Bolaji Coker, Matias C. Vieira, Natalie Moitt, Walter Muruet Gutierrez, Asma Khalil, Jane Sandall, Andrew Copas, Deborah A. Lawlor and Dharmintra Pasupathy

    Citation: Trials 2021 22:195

    Content type: Methodology

    Published on:

  3. It is increasingly accepted that insufficient attention has been given to the patient health outcomes that are important to measure in comparative effectiveness research that will inform decision-making. The r...

    Authors: Susanna Dodd, Nicola Harman, Nichole Taske, Mark Minchin, Toni Tan and Paula R. Williamson

    Citation: Trials 2020 21:570

    Content type: Commentary

    Published on:

  4. Clinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) acces...

    Authors: Sarah Lensen, Archie Macnair, Sharon B. Love, Victoria Yorke-Edwards, Nurulamin M. Noor, Meredith Martyn, Alexandra Blenkinsop, Carlos Diaz-Montana, Graham Powell, Elizabeth Williamson, James Carpenter and Matthew R. Sydes

    Citation: Trials 2020 21:398

    Content type: Research

    Published on:

  5. We aimed to test whether a common set of key data items reported across high-impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonata...

    Authors: Sena Jawad, Neena Modi, A. Toby Prevost and Chris Gale

    Citation: Trials 2019 20:731

    Content type: Review

    Published on:

  6. The weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be us...

    Authors: Tomotsugu Seki, Morio Aki, Hirotsugu Kawashima, Tomotaka Miki, Shiro Tanaka, Koji Kawakami and Toshi A. Furukawa

    Citation: Trials 2019 20:706

    Content type: Study protocol

    Published on: