Evidence map›Paper›PMID 39936621›Full record

ArticleClinical and translational science2025

The Role and Challenges of Investigator-Initiated Trials in the Cell and Gene Therapy Products Boom in Mainland China.

Yifan Yang, Lianlian Bian, Yuan Cheng, Yan Xu, Hui Shao, Jian Rao, Sixiang Ge, Jifang Gong, Min Jiang, Xiaoyu Zheng and 5 more

Abstract read
In one paragraph

Article in Clinical and translational science, 2025. 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
–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

3 citing papers in PubMed.

  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

15 authors.

Yifan YangChangping Laboratory, Beijing, China.ORCID 0000-0003-0512-2739
Lianlian BianChangping Laboratory, Beijing, China.ORCID 0000-0001-8249-2413
Yuan ChengChangping Laboratory, Beijing, China.
Yan XuPeking University Third Hospital, Beijing, China.
Hui ShaoChangping Laboratory, Beijing, China.
Jian RaoChangping Laboratory, Beijing, China.
Sixiang GeChangping Laboratory, Beijing, China.
Jifang GongBeijing Cancer Hospital, Beijing, China.
Min JiangBeijing Cancer Hospital, Beijing, China.
Xiaoyu ZhengGoBroad Healthcare Group, Beijing, China.
Lijun LiuInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
Shihui MaInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
Xuan LiuTsinghua Changgung Hospital, Beijing, China.
Tao ChengInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
Chenyan GaoChangping Laboratory, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As cutting-edge technologies in biomedicine, cell and gene therapy (CGT) products demonstrate immense potential in treating cancer, rare diseases, and genetic disorders, thereby driving the importance of clinical research in this area. This study analyzes the growth trends and key characteristics of 1033 Investigator-Initiated Trials (IITs) conducted by mainland Chinese institutions in the CGT field. The results show that IITs have played a positive role in the early proof-of-concept of CGT products, helping to obtain preliminary safety and efficacy data, and exploring the combination of CGT products with other therapies. Additionally, this study discusses the regional distribution, therapeutic areas, and challenges faced by IITs in the development of CGT products in China. Based on these findings, policy suggestions are proposed to optimize the regulation of IITs in mainland China, such as improving regulatory frameworks and enhancing technical guidance. It is hoped that these measures will further improve the efficiency and quality of IITs, fully utilize the large patient base and abundant clinical resources, and support the development of high-quality CGT products in mainland China.

Indexed as

Cell- and Tissue-Based TherapyClinical Trials as TopicGenetic TherapyResearch PersonnelChinaGene Therapy AgentsHumanscell and gene therapyClinicalTrials.Govinvestigational new druginvestigator‐initiated trialsquasi‐dual‐track regulatory

Identifiers

PMID39936621
PMCPMC11815567

What OpenQuestion holds

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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.