Evidence map›Paper›PMID 25993165›Full record

ReviewAmerican Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting2015

Improving Clinical Trial Efficiency: Thinking outside the Box.

Sumithra J Mandrekar, Suzanne E Dahlberg, Richard Simon

Abstract readReview
In one paragraph

Review in American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
–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

31 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Application of radiomics in lung immuno-oncology.Precision radiation oncology · 2023
    Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Review
  15. Toward A Universal Biomedical Data Translator.Clinical and translational science · 2019
    Article
  16. Review
  17. Master protocol trials in oncology: Review and new trial designs.Contemporary clinical trials communications · 2018
    Article
  18. Article
  19. Article
  20. Adaptive Designs for Clinical Trials: Application to Healthcare Epidemiology Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Review
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

3 authors.

Sumithra J MandrekarFrom the Mayo Clinic, Rochester, MN; Dana-Farber Cancer Institute, Boston, MA; National Institutes of Health, Rockville, MD.
Suzanne E DahlbergFrom the Mayo Clinic, Rochester, MN; Dana-Farber Cancer Institute, Boston, MA; National Institutes of Health, Rockville, MD.
Richard SimonFrom the Mayo Clinic, Rochester, MN; Dana-Farber Cancer Institute, Boston, MA; National Institutes of Health, Rockville, MD.

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

Clinical trial design strategies have evolved over the past few years as a means to accelerate the drug development process so that the right therapies can be delivered to the right patients. Basket, umbrella, and adaptive enrichment strategies represent a class of novel designs for testing targeted therapeutics in oncology. Umbrella trials include a central infrastructure for screening and identification of patients, and focus on a single tumor type or histology with multiple subtrials, each testing a targeted therapy within a molecularly defined subset. Basket trial designs offer the possibility to include multiple molecularly defined subpopulations, often across histology or tumor types, but included in one cohesive design to evaluate the targeted therapy in question. Adaptive enrichment designs offer the potential to enrich for patients with a particular molecular feature that is predictive of benefit for the test treatment based on accumulating evidence from the trial. This review will aim to discuss the fundamentals of these design strategies, the underlying statistical framework, the logistical barriers of implementation, and, ultimately, the interpretation of the trial results. New statistical approaches, extensive multidisciplinary collaboration, and state of the art data capture technologies are needed to implement these strategies in practice. Logistical challenges to implementation arising from centralized assay testing, requirement of multiple specimens, multidisciplinary collaboration, and infrastructure requirements will also be discussed. This review will present these concepts in the context of the National Cancer Institute's precision medicine initiative trials: MATCH, ALCHEMIST, Lung MAP, as well as other trials such as FOCUS4.

Indexed as

Clinical Trials as TopicHumansResearch Design

Identifiers

PMID25993165
PMCPMC6995119

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.