Evidence map›Paper›PMID 25908602›Full record

ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2015

Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial.

J Rodon, J C Soria, R Berger, G Batist, A Tsimberidou, C Bresson, J J Lee, E Rubin, A Onn, R L Schilsky and 5 more

Open access · bronzeAbstract read
In one paragraph

Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
5.4field-weighted citation impact, top 3% 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.

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

39 citing papers in PubMed, 74 citations in OpenAlex.

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  8. Drivers of Start-Up Delays in Global Randomized Clinical Trials.Therapeutic innovation & regulatory science · 2021
    Article
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  10. Strategies for Testing Intervention Matching Schemes in Cancer.Clinical pharmacology and therapeutics · 2020
    Review
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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

15 authors at 9 institutions in 6 countries.

J RodonVall D'Hebron Institute of Oncology and Universitat Autonoma de Barcelona, Barcelona, Spain jrodon@vhio.net.
J C SoriaGustave Roussy Cancer Campus Grand Paris, Villejuif, France.
R BergerOncology Institute, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
G BatistSegal Cancer Center, Jewish General Hospital Mcgill University, Montreal Quebec Consortium de Recherche en Oncologie Clinique, Quebec, Canada.
A TsimberidouThe University of Texas MD Anderson Cancer Center, Houston, USA.
C BressonWIN Consortium, Villejuif, France.
J J LeeThe University of Texas MD Anderson Cancer Center, Houston, USA.
E RubinThe National Institute of Biotechnology in the Negev, Ben Gurion University, Beer-Sheva, Israel.
A OnnOncology Institute, Chaim Sheba Medical Center, Tel-Hashomer, Israel.
R L SchilskyAmerican Society of Clinical Oncology (ASCO), Alexandria.
W H MillerSegal Cancer Center, Jewish General Hospital Mcgill University, Montreal Quebec Consortium de Recherche en Oncologie Clinique, Quebec, Canada.
A M EggermontGustave Roussy Cancer Campus Grand Paris, Villejuif, France.
J MendelsohnThe University of Texas MD Anderson Cancer Center, Houston, USA.
V LazarGustave Roussy Cancer Campus Grand Paris, Villejuif, France.
R KurzrockCenter for Personalized Cancer Therapy, UC San Diego-Moores Cancer Center, La Jolla, USA.
Institut Gustave Roussy · FRThe University of Texas MD Anderson Cancer Center · USJewish General Hospital · CASheba Medical Center · ILAmerican Society of Clinical Oncology · USBen-Gurion University of the Negev · ILUniversitat Autònoma de Barcelona · ESUniversity of California San Diego · USWIN Consortium

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

Advances in 'omics' technology and targeted therapeutic molecules are together driving the incorporation of molecular-based diagnostics into the care of patients with cancer. There is an urgent need to assess the efficacy of therapy determined by molecular matching of patients with particular targeted therapies. WINTHER is a clinical trial that uses cutting edge genomic and transcriptomic assays to guide treatment decisions. Through the lens of this ambitious multinational trial (five countries, six sites) coordinated by the Worldwide Innovative Networking Consortium for personalized cancer therapy, we discovered key challenges in initiation and conduct of a prospective, omically driven study. To date, the time from study concept to activation has varied between 19 months at Gustave Roussy Cancer Campus in France to 30 months at the Segal Cancer Center, McGill University (Canada). It took 3+ years to be able to activate US sites due to national regulatory hurdles. Access to medications proposed by the molecular analysis remains a major challenge, since their availability through active clinical trials is highly variable over time within sites and across the network. Rules regarding the off-label use of drugs, or drugs not yet approved at all in some countries, pose a further challenge, and many biopharmaceutical companies lack a simple internal mechanism to supply the drugs even if they wish to do so. These various obstacles should be addressed to test and then implement precision medicine in cancer.

Indexed as

Antineoplastic AgentsCanadaClinical Trials as TopicFranceGene Expression ProfilingGenomicsHumansIsraelMolecular Targeted TherapyNeoplasmsPrecision MedicineProspective StudiesSpainUnited StatesAntineoplastic Agentsbiomarkerclinical trialspersonalized cancer therapy

Identifiers

PMID25908602
PMCPMC5006164
OpenAlexW2170049466

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.