Evidence map›Paper›PMID 26827695›Full record

ReviewCancer treatment reviews2016

Clinical trial designs incorporating predictive biomarkers.

Lindsay A Renfro, Himel Mallick, Ming-Wen An, Daniel J Sargent, Sumithra J Mandrekar

Abstract readReview
In one paragraph

Review in Cancer treatment reviews, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing 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

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

  1. Pooled it
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  8. Article
  9. Article
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  14. Application of radiomics in lung immuno-oncology.Precision radiation oncology · 2023
    Review
  15. Article
  16. Innovative trial design in precision oncology.Seminars in cancer biology · 2022
    Review
  17. Review
  18. Article
  19. Article
  20. An Overview of Phase 2 Clinical Trial Designs.International journal of radiation oncology, biology, physics · 2022
    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

5 authors.

Lindsay A RenfroDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA. Electronic address: renfro.lindsay@mayo.edu.
Himel MallickDepartment of Biostatistics, Harvard School of Public Health, Boston, MA, USA; The Broad Institute of MIT and Harvard, Cambridge, MA, USA.
Ming-Wen AnDepartment of Mathematics and Statistics, Vassar College, Poughkeepsie, NY, USA.
Daniel J SargentDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.
Sumithra J MandrekarDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.

Funding

Mayo Clinic Center for Translational Science ActivitiesKL2TR000136 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$6.6M
Methodology for development, validation, and use of novel endpoints in oncologyR01CA174779 · NCI · MAYO CLINIC ROCHESTER · PI MANDREKAR, SUMITHRA JAY · 2014 to 2017
$1.2M
NCATS NIH HHS KL2 TR000136NCI NIH HHS R01 CA174779
6 · The paper itself

Abstract

Development of oncologic therapies has traditionally been performed in a sequence of clinical trials intended to assess safety (phase I), preliminary efficacy (phase II), and improvement over the standard of care (phase III) in homogeneous (in terms of tumor type and disease stage) patient populations. As cancer has become increasingly understood on the molecular level, newer "targeted" drugs that inhibit specific cancer cell growth and survival mechanisms have increased the need for new clinical trial designs, wherein pertinent questions on the relationship between patient biomarkers and response to treatment can be answered. Herein, we review the clinical trial design literature from initial to more recently proposed designs for targeted agents or those treatments hypothesized to have enhanced effectiveness within patient subgroups (e.g., those with a certain biomarker value or who harbor a certain genetic tumor mutation). We also describe a number of real clinical trials where biomarker-based designs have been utilized, including a discussion of their respective advantages and challenges. As cancers become further categorized and/or reclassified according to individual patient and tumor features, we anticipate a continued need for novel trial designs to keep pace with the changing frontier of clinical cancer research.

Indexed as

Antineoplastic AgentsBiomarkersNeoplasmsClinical Trials as TopicHumansMolecular Targeted TherapyPredictive Value of TestsResearch DesignAntineoplastic AgentsBiomarkersAdaptive trial designBayesian adaptive designBiomarker-based designClinical trial designEnrichment designsTargeted therapies

Identifiers

PMID26827695
PMCPMC4737867

What OpenQuestion holds

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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.