Evidence map›Paper›PMID 29330642›Full record

ArticleInternational journal of clinical oncology2018

Meta-analysis of randomized clinical trials in the era of individual patient data sharing.

Takuya Kawahara, Musashi Fukuda, Koji Oba, Junichi Sakamoto, Marc Buyse

Abstract read
In one paragraph

Article in International journal of clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. CONSIDER Statement: Consolidated Recommendations for Sharing Individual Participant Data from Human Clinical Studies.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science
    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

5 authors.

Takuya KawaharaDepartment of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Annex of Bldg. 3, 5th Floor, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
Musashi FukudaDepartment of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Annex of Bldg. 3, 5th Floor, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
Koji ObaDepartment of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Annex of Bldg. 3, 5th Floor, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. oba@epistat.m.u-tokyo.ac.jp.
Junichi SakamotoTokai Central Hospital, 4-6-2 Sohara Higashijima-cho, Kakamigahara, Gifu, 504-8601, Japan.
Marc BuyseInternational Drug Development Institute (IDDI) Inc., San Francisco, CA, 94109, USA.

Funding

Japan Society for the Promotion of Science (JP) 15617613
6 · The paper itself

Abstract

backgroundIndividual patient data (IPD) meta-analysis is considered to be a gold standard when the results of several randomized trials are combined. Recent initiatives on sharing IPD from clinical trials offer unprecedented opportunities for using such data in IPD meta-analyses.

methodsFirst, we discuss the evidence generated and the benefits obtained by a long-established prospective IPD meta-analysis in early breast cancer. Next, we discuss a data-sharing system that has been adopted by several pharmaceutical sponsors. We review a number of retrospective IPD meta-analyses that have already been proposed using this data-sharing system. Finally, we discuss the role of data sharing in IPD meta-analysis in the future.

resultsTreatment effects can be more reliably estimated in both types of IPD meta-analyses than with summary statistics extracted from published papers. Specifically, with rich covariate information available on each patient, prognostic and predictive factors can be identified or confirmed. Also, when several endpoints are available, surrogate endpoints can be assessed statistically.

conclusionsAlthough there are difficulties in conducting, analyzing, and interpreting retrospective IPD meta-analysis utilizing the currently available data-sharing systems, data sharing will play an important role in IPD meta-analysis in the future.

Indexed as

Information DisseminationMeta-Analysis as TopicRandomized Controlled Trials as TopicBreast NeoplasmsFemaleHealth Records, PersonalHumansPrognosisData sharingIndividual patient dataMeta-analysis

Identifiers

PMID29330642
PMCPMC5951901

What OpenQuestion holds

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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.