Evidence map›Paper›PMID 26473188›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2015

Advancing Clinical Trials to Streamline Drug Development.

Susan E Bates, Donald A Berry, Sanjeeve Balasubramaniam, Stuart Bailey, Patricia M LoRusso, Eric H Rubin

Abstract readEditorial
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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

18 citing papers in PubMed.

  1. Erk5-mediated microglial ferroptosis drives ischemic white matter damage via the Nfatc4-Clptm1l axis.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
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  12. Article
  13. Combination immunotherapy: a road map.Journal for immunotherapy of cancer · 2017
    Review
  14. Article
  15. Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Review
  16. Article
  17. Article
  18. Next-Generation Sequencing to Guide Clinical Trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2015
    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

6 authors.

Susan E BatesDevelopmental Therapeutics Branch, National Cancer Institute, Bethesda, Maryland. seb2227@cumc.columbia.edu.
Donald A BerryUniversity of Texas MD Anderson Cancer Center, Houston, Texas.
Sanjeeve BalasubramaniamOffice of Hematology and Oncology Products, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland.
Stuart BaileyNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Patricia M LoRussoYale Cancer Center, Yale School of Medicine, New Haven, Connecticut.
Eric H RubinMerck Research Laboratories, North Wales, Pennsylvania.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Intramural NIH HHS Z99 CA999999NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

The last decade in oncology has been marked by the identification of numerous new potential cancer targets and even more agents designed to inhibit them. The matrix of new targets, new agents, and the companion diagnostics required to identify the right patient for the right drug has created a major challenge for the clinical trial process. This has been compounded by the addition of new immunomodulators targeting the host immune system rather than the tumor. Recognizing the need for new approaches, industry, investigators, and regulators have responded to this challenge. New clinical trial designs are being evaluated to incorporate the genomic sequence data being obtained almost routinely after cancer diagnosis. New dose-finding approaches are being proposed to identify the maximum effective dose rather than the maximum tolerated dose. The FDA is involved in the drug approval process from points early in development and has accepted registration quality data from expansion cohorts in support of drug approval. Despite progress on several fronts, many challenges remain, including the lack of predictability of preclinical data for clinical results and phase II data for phase III results, an infrastructure that can be an obstacle to clinical trial development and implementation, and the increasing use of contracted clinical research organizations that limit a fit-for-purpose approach to clinical trial execution. Perhaps most challenging and important of all are the difficulties with clinical trial accrual that can prevent study completion. Both the innovations and the challenges highlight the important role of process in progress in clinical oncology.

Indexed as

AnimalsAntineoplastic AgentsClinical Trials as TopicDrug ApprovalDrug DiscoveryGenomicsHumansNeoplasmsResearch PersonnelAntineoplastic Agents

Identifiers

PMID26473188
PMCPMC6063985

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.