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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. The incidence of colorectal cancer among the middle-aged and elderly is gradually increasing in China. Colonoscopy is an effective method for the early diagnosis of colorectal cancer, and bowel preparation is ...

    Authors: Xing Wang Zhu, Jun Yan, Long Miao, Ying Li He, Hai Ping Wang and Xun Li
    Citation: Trials 2023 24:168
    Content type: Study protocol Published on:

  2. Acquired immune deficiency syndrome is caused by humans and is high worldwide. Active antiretroviral therapy emerged in the late 1990s and is effective against AIDS. However, despite the extensive research on ...

    Authors: Xue Ding, Pengfei Meng, Xiuxia Ma, Weifeng Cui, Liangping Li, Xiyuan Song, Jiangrong Wang, Chengjie Ma, Xin Chen and Liran Xu
    Citation: Trials 2022 23:665
    Content type: Study protocol Published on:

  3. Tobacco hazard is one of the most serious public health problems, accounting for up to 6 million deaths worldwide p.a. We aim to determine the efficacy and safety of acupuncture and/or nicotine replacement the...

    Authors: Qingsheng Wang, Runjing Dai, Hailiang Zhang, Xiaomei Jiang, Xiaojing Ma, Xiangrong Zhang, Shisan Bao, Dong Ren and Jingchun Fan
    Citation: Trials 2022 23:465
    Content type: Study protocol Published on:

  4. Home noninvasive positive pressure ventilation (NIPPV) has become evidence-based care for stable hypercapnic chronic obstructive pulmonary disease (COPD) patients. There are still other challenges including ap...

    Authors: Weipeng Jiang and Yuanlin Song
    Citation: Trials 2022 23:393
    Content type: Study protocol Published on:

  5. Metastasis and/or recurrence can decrease the survival time of gastric cancer patients undergoing radical operation. Among them, those with stage IIIb and IIIc are especially at a high risk of metastasis and r...

    Authors: Zhaoyan Li, Guangtao Zhang, Nida Cao, Jingjuan Xu, Jiahuan Dong, Jia Li, Xiaohong Zhu, Yan Xu, Chen Han, Rui Wang, Xiang Xia, Gang Zhao, Xiangkun Huan, Jin Fan and Aiguang Zhao
    Citation: Trials 2022 23:68
    Content type: Study protocol Published on:

  6. Primary dysmenorrhea (PD) is one of the main gynecological complaints in women of child-bearing age, but limited effective treatments are available. Guizhi Fuling Wan (GFW), one of the most widely known tradit...

    Authors: Yun Du, Yatong Li, Xianyun Fu, Chenjie Li and Luo Yanan
    Citation: Trials 2021 22:933
    Content type: Study protocol Published on:

    The Correction to this article has been published in Trials 2021 22:967

  7. Gastric cancer, which is the fifth most common malignancy and the third most common cause of cancer-related death, is particularly predominant in East Asian countries, such as China, Japan and Korea. It is a s...

    Authors: Cheng Meng, Shougen Cao, Xiaodong Liu, Leping Li, Qingsi He, Lijian Xia, Lixin Jiang, Xianqun Chu, Xinjian Wang, Hao Wang, Xizeng Hui, Zuocheng Sun, Shusheng Huang, Quanhong Duan, Daogui Yang, Huanhu Zhang…
    Citation: Trials 2021 22:912
    Content type: Study protocol Published on:

  8. The benefits of mother’s own milk (MOM) for preterm infants have been widely recognized. Many studies have shown that the rate of breastfeeding of premature infants remains very low. Although many studies use ...

    Authors: Jie Huo, Xinping Wu, Chuanli Gu, Zhangbin Yu, Jun Zhang, Xiaohui Chen, Jingai Zhu, Feng Liu, Beibei Liu, Qianqian Li and Shuping Han
    Citation: Trials 2021 22:834
    Content type: Study protocol Published on:

  9. Proton pump inhibitor (PPI) is effective for the treatment of nonerosive gastroesophageal reflux (NERD), but long-term use of PPI is prone to have complications and recurrence after withdrawal. Traditional Chi...

    Authors: Xiaosi Zhang, Yuan Cheng, Xiaohong Li, Xiang Tan, Lei Shi, Xiaojun Shi, Xiancui Zhang, Chun’e Xie and Junxiang Li
    Citation: Trials 2021 22:545
    Content type: Study protocol Published on:

  10. Lumbar spinal stenosis (LSS) is a common degenerative condition associated with old age. Its incidence continues to increase with the rapidly aging population in China. Treatment for LSS usually begins with co...

    Authors: Akram Osman, Wei Hu, Jianhua-Sun, Jing Li, Xiao Luo, Nianrong Han, Ehsan Abduhani and Zhenqiang Liu
    Citation: Trials 2021 22:524
    Content type: Study protocol Published on:

  11. 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:

  12. 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:

  13. 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:

  14. Many technology companies, including Airbnb, Amazon, Booking.​com, eBay, Facebook, Google, LinkedIn, Lyft, Microsoft, Netflix, Twitter, Uber, and Yahoo!/Oath, run online randomized controlled experiments at scale,...

    Authors: Ron Kohavi, Diane Tang, Ya Xu, Lars G. Hemkens and John P. A. Ioannidis
    Citation: Trials 2020 21:150
    Content type: Methodology Published on:

  15. 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:

  16. 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: