Evidence map›Paper›PMID 28195238›Full record

ReviewNature reviews. Clinical oncology2017

The changing landscape of clinical trial and approval processes in China.

Qing Zhou, Xiao-Yuan Chen, Zhi-Min Yang, Yi-Long Wu

Abstract readReview
PubMed Publisher
In one paragraph

Review in Nature reviews. Clinical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 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

40 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  19. Characteristics and Trends in Clinical Trials of Cardiovascular Drugs in China from 2009 to 2021.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023
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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

4 authors.

Qing ZhouGuangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, China.
Xiao-Yuan ChenCenter for Drug Evaluation (CDE), China Food and Drug Administration (CFDA), 26 Xuanwumen Xidajie, Beijing 100053, China.
Zhi-Min YangCenter for Drug Evaluation (CDE), China Food and Drug Administration (CFDA), 26 Xuanwumen Xidajie, Beijing 100053, China.
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, 106 Zhongshan Er Road, Guangzhou 510080, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the past decade, the standards of clinical trials in China have moved closer to international standards, thus encouraging the development of innovative drugs. However, a large backlog of pending applications for both drug approval and clinical trial registration has arisen owing to the complexity of the approval process, the volume of applications and a lack of staff available to process these applications, among other reasons. To improve the drug approval process, a 'four-colour-light' strategy was introduced. Different drugs are classified into redefined categories of innovative and generic drugs, with priority being given to approval decisions concerning innovative drugs. Other improvement strategies are now also being implemented, including the development of a new clinical trial approval system and several measures designed to encourage greater participation of Chinese researchers and research centres in international clinical trials. In this Perspective, the changing landscape of clinical approval in China is described, including the difficulties that drug approval authorities face in this rapidly developing nation and the novel strategies that are being used to find solutions.

Indexed as

Antineoplastic AgentsChinaClinical Trials as TopicDrug ApprovalHumansRegistriesAntineoplastic Agents

Identifiers

PMID28195238

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.