Evidence map›Paper›PMID 21448748›Full record

ArticleThe AAPS journal2011

Translational biomarkers: from preclinical to clinical a report of 2009 AAPS/ACCP Biomarker Workshop.

Jane P F Bai, Robert Bell, ShaAvhree Buckman, Gilbert J Burckart, Hans-Georg Eichler, Kenneth C Fang, Federico M Goodsaid, William J Jusko, Lawrence L Lesko, Bernd Meibohm and 8 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in The AAPS journal, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00113763 (An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.0field-weighted citation impact, top 13% of its field
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.

NCT00113763 phase3completednot on this map

An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer

TypeinterventionalSponsorAmgenRan2004 to 2009Enrolled463ConditionsColorectal Cancer, MetastasesArmsBest supportive care, Panitumumab
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 35 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Recent developments inDrug metabolism reviews · 2021
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Proteomics and metabolomics in renal transplantation-quo vadis?Transplant international : official journal of the European Society for Organ Transplantation · 2013
    Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

18 authors at 11 institutions in 2 countries.

Jane P F BaiOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. jbai.bai@fda.hhs.gov
Robert Bell
ShaAvhree Buckman
Gilbert J Burckart
Hans-Georg Eichler
Kenneth C Fang
Federico M Goodsaid
William J Jusko
Lawrence L Lesko
Bernd Meibohm
Scott D Patterson
Oscar Puig
Jeffrey B Smerage
Barbara J Snider
John A Wagner
Jingsong Wang
Marc K Walton
Russell Weiner
Center for Drug Evaluation and Research · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USUnited States Food and Drug Administration · USAmgen (United States) · USBristol-Myers Squibb (Germany) · DEBristol-Myers Squibb (United States) · USProtein Express (United States) · USUniversity at Buffalo, State University of New York · USUniversity of Michigan–Ann Arbor · USUniversity of Tennessee Health Science Center · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There have been some successes in qualifying biomarkers and applying them to drug development and clinical treatment of various diseases. A recent success is illustrated by a collaborative effort among the US Food and Drug Administration, the European Medicines Agency, and the pharmaceutical industry to provide a set of seven preclinical kidney toxicity biomarkers for drug development. Other successes include, but are not limited to, clinical biomarkers for cancer treatment and clinical management of heart transplant patients. The value of fully qualified surrogate endpoints in facilitating successful drug development is undisputed, especially for diseases in which the traditional clinical outcome can only be assessed in large, multi-year trials. Emerging biomarkers, including chemical genomic or imaging biomarkers, and measurement of circulating tumor cells hold great promise for early diagnosis of disease and as prognostic tests for managing treatment of chronic diseases such as osteoarthritis, Alzheimer disease, cardiovascular disease, and cancer. To advance the success of treating and managing these diseases, efforts are needed to establish the temporal relationship between changes in inflammatory or imaging biomarkers with the progression of the chronic disease, and in the case of cancer, between the extent of circulating cancer cells and tumor progression or remission.

Indexed as

Drug DesignAnimalsBiomarkersClinical Trials as TopicDrug Evaluation, PreclinicalDrug IndustryHumansInternational CooperationBiomarkers

Identifiers

PMID21448748
PMCPMC3085704
OpenAlexW2042150021

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.