Evidence map›Paper›PMID 28913177›Full record

ArticleFrontiers in oncology2017

Big Data in Designing Clinical Trials: Opportunities and Challenges.

Charles S Mayo, Martha M Matuszak, Matthew J Schipper, Shruti Jolly, James A Hayman, Randall K Ten Haken

Abstract read
In one paragraph

Article in Frontiers in oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Shaken not stirred: Big data meets randomized controlled trial.Medical journal, Armed Forces India · 2021
    Article
  7. Article
  8. Article
  9. Review
  10. Role of Big Data in Cardiovascular Research.Journal of the American Heart Association · 2019
    Review
  11. Big data in IBD: a look into the future.Nature reviews. Gastroenterology & hepatology · 2019
    Review
  12. Article
  13. Aging Well: Using Precision to Drive Down Costs and Increase Health Quality.Advances in geriatric medicine and research · 2019
    Article
  14. Article
  15. Article
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Charles S MayoDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, United States.
Martha M MatuszakDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, United States.
Matthew J SchipperDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, United States.
Shruti JollyDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, United States.
James A HaymanDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, United States.
Randall K Ten HakenDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Emergence of big data analytics resource systems (BDARSs) as a part of routine practice in Radiation Oncology is on the horizon. Gradually, individual researchers, vendors, and professional societies are leading initiatives to create and demonstrate use of automated systems. What are the implications for design of clinical trials, as these systems emerge? Gold standard, randomized controlled trials (RCTs) have high internal validity for the patients and settings fitting constraints of the trial, but also have limitations including: reproducibility, generalizability to routine practice, infrequent external validation, selection bias, characterization of confounding factors, ethics, and use for rare events. BDARS present opportunities to augment and extend RCTs. Preliminary modeling using single- and muti-institutional BDARS may lead to better design and less cost. Standardizations in data elements, clinical processes, and nomenclatures used to decrease variability and increase veracity needed for automation and multi-institutional data pooling in BDARS also support ability to add clinical validation phases to clinical trial design and increase participation. However, volume and variety in BDARS present other technical, policy, and conceptual challenges including applicable statistical concepts, cloud-based technologies. In this summary, we will examine both the opportunities and the challenges for use of big data in design of clinical trials.

Indexed as

analyticsbig datainformaticsrandomized controlled trialstrial design

Identifiers

PMID28913177
PMCPMC5583160

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.