Evidence map›Paper›PMID 26919617›Full record

ReviewCancer science2016

Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.

Yoshihiro Hayakawa, Manabu Kawada, Hiroyoshi Nishikawa, Takahiro Ochiya, Hideyuki Saya, Hiroyuki Seimiya, Ryoji Yao, Masahiro Hayashi, Chieko Kai, Akira Matsuda and 9 more

Open access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Cancer science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

19 authors at 14 institutions in 2 countries.

Yoshihiro HayakawaSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Manabu KawadaSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Hiroyoshi NishikawaSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Takahiro OchiyaSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Hideyuki SayaSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Hiroyuki SeimiyaSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Ryoji YaoSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Masahiro HayashiSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Chieko KaiSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Akira MatsudaSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Tomoki NaoeSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Atsushi OhtsuSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Taku OkazakiSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Hideo SajiSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Masataka SataSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Haruhiko SugimuraSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Yuichi SugiyamaSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Masakazu ToiSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Tatsuro IrimuraSubcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Pharmaceuticals and Medical Devices Agency · JPTokushima University · JPChiba Cancer Center · JPHokkaido University · JPJapanese Foundation For Cancer Research · JPJuntendo University · JPKeio University · JPKyoto Pharmaceutical University · JPKyoto University · JPMicrobial Chemistry Research Foundation · JPNagoya Medical Center · JPThe University of Tokyo · JPToranomon Hospital · JPUniversity of Toyama · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs.

Indexed as

Disease Models, AnimalNeoplasmsAnimalsAntineoplastic AgentsDrug DiscoveryHumansMedical OncologyAntineoplastic AgentsAnimal modelcancerdrug developmentoncology drugregulatory science

Identifiers

PMID26919617
PMCPMC4768389
OpenAlexW2285427682

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.