Evidence map›Paper›PMID 28376159›Full record

ArticleJournal of the National Cancer Institute2017

Burdensome Research Procedures in Trials: Why Less Is More.

Jonathan Kimmelman, David B Resnik, Jeffrey Peppercorn, Mark J Ratain

Abstract read
In one paragraph

Article in Journal of the National Cancer Institute, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee.Journal of empirical research on human research ethics : JERHRE · 2020
    Article
  12. Biomarker development for axial spondyloarthritis.Nature reviews. Rheumatology · 2020
    Review
  13. Article
  14. Article
  15. Tissue Acquisition in Clinical Trials-Essential for Progress.Journal of the National Cancer Institute · 2017
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Jonathan KimmelmanStudies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Social Studies of Medicine, McGill University, Montréal, Canada.
David B ResnikNational Institute of Environmental Health Sciences, Research Triangle Park, NC, USA.
Jeffrey PeppercornMGH Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Mark J RatainDepartment of Medicine, Comprehensive Cancer Center, and Center for Personalized Therapeutics, The University of Chicago, Chicago, IL, USA.

Funding

Ethical, social, and legal issues in environmental health researchZIAES102646 · NIEHS · NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES · PI RESNIK, DAVID · 2009 to 2025
$1.8M
6 · The paper itself

Abstract

A large volume of trials involve invasive, nontherapeutic research procedures, like organ biopsy or sham surgeries, that can pose risks comparable with the experimental treatment itself but that have no direct benefit for volunteers. Though such procedures can enhance the value of clinical investigations, recent studies suggest that many studies involving invasive, nontherapeutic research procedures are not well planned and reported; some studies suggest that their results are often not utilized in the planning of new investigations. This commentary offers recommendations for how investigators, sponsors, and ethics committees might improve evaluation and implementation of studies involving invasive nontherapeutic procedures. We conclude by urging more demanding scientific standards for the rationale, design, and reporting of burdensome, nontherapeutic research procedures-particularly where they involve risk of serious complications.

Indexed as

Healthy VolunteersBiopsyClinical Trials as TopicHumansNontherapeutic Human ExperimentationPlacebosPlacebos

Identifiers

PMID28376159
PMCPMC5756064

What OpenQuestion holds

Textmetadata
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.