Evidence map›Paper›PMID 38494842›Full record

ReviewJournal of biopharmaceutical statistics2024

Establishment of RWS guidance reflecting contributions of China to regulatory science.

Jun Wang, Jie Chen, Jun Zhao, Ying Wu, Xiaona Xin, Pingyan Chen

Erratum issuedAbstract readReview
PubMed Publisher
In one paragraph

Review in Journal of biopharmaceutical statistics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Jun WangCenter for Drug Evaluation, The National Medical Products Administration, Beijing, China.
Jie ChenCenter for Innovative Study Design, Stanford University, Palo Alto, California, USA.
Jun ZhaoCenter for Drug Evaluation, The National Medical Products Administration, Beijing, China.
Ying WuDepartment of Biostatistics, Southern Medical University, Guangzhou, China.
Xiaona XinCenter for Drug Evaluation, The National Medical Products Administration, Beijing, China.
Pingyan ChenDepartment of Biostatistics, Southern Medical University, Guangzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

China's accession to the ICH has accelerated the advancement of its regulatory science. To foster innovation and improve the efficiency of pharmaceutical research and development, the China National Medical Products Administration (NMPA) encourages the use of real-world evidence (RWE) to support drug regulatory decision-making and has constructed a series of real-world study (RWS) related guidance, reflecting the contribution of the NMPA to the field of RWS in drug clinical development. Based on the four guidelines on RWE, real-world data (RWD), RWS design and protocol development, and communication with regulatory authorities, the guidance has been extended to more specific clinical applications, such as oncology, rare diseases, pediatric drugs, and traditional Chinese medicine. This paper reviews the core content and features of the series of RWS guidelines, presents their role in promoting drug development, and discusses challenges of using RWE in support of drug regulatory decision-making in China.

Indexed as

Drug DevelopmentChinaDecision MakingDrug ApprovalGuidelines as TopicHumansclinical developmentdrug registrationReal-world datareal-world evidencereal-world studies

Identifiers

PMID38494842

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.