Evidence map›Paper›PMID 39948234›Full record

ReviewTherapeutic innovation & regulatory science2025

Changes in Clinical Trials of Dermatological Drugs in Mainland China Between 2016 and 2022: A Narrative Review.

Beibei Zhu, Jing Li, Qi Ni, Shuo Yang, Zheng Yin, Xueyuan Yang

Abstract readReview
PubMed Publisher
In one paragraph

Review in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

6 authors.

Beibei ZhuChinese Academy of Medical Sciences & Peking Union Medical College of Skin Diseases and Institute of Dermatology, Xuanwu District, No.12 Jiangwangmiao St., Nanjing, 210042, China.
Jing LiChinese Academy of Medical Sciences & Peking Union Medical College of Skin Diseases and Institute of Dermatology, Xuanwu District, No.12 Jiangwangmiao St., Nanjing, 210042, China.
Qi NiChinese Academy of Medical Sciences & Peking Union Medical College of Skin Diseases and Institute of Dermatology, Xuanwu District, No.12 Jiangwangmiao St., Nanjing, 210042, China.
Shuo YangIQVIA Solutions Enterprise Management Consulting Shanghai Co Ltd, Shanghai, 200124, China.
Zheng YinIQVIA Solutions Enterprise Management Consulting Shanghai Co Ltd, Shanghai, 200124, China.
Xueyuan YangChinese Academy of Medical Sciences & Peking Union Medical College of Skin Diseases and Institute of Dermatology, Xuanwu District, No.12 Jiangwangmiao St., Nanjing, 210042, China. yangxueyuan@medmail.com.cn.

Funding

Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences 2021-I2M-1-045
6 · The paper itself

Abstract

introductionPolicy reforms in drug regulation and reimbursement have encouraged drug research and development in China. However, there is a lack of insights on industry trends for dermatology research. We aim to describe trends and features of clinical trials for dermatology drugs in China, understand recent achievements, and forecast development trends.

methodsClinical trial records posted on the Registration and Information Disclosure Platform of Center for Drug Evaluation (CDE) were screened. All trials for dermatological drugs, posted on platform between 2016 and 2022 were included.

resultsA total of 1172 trial records were identified, among which studies for skin infection, immune-mediated and inflammatory skin disease (IMIDs) and skin malignancy accounted for 48.9% (n = 573), 42.0% (n = 492) and 9.1% (n = 107), respectively. Most trials focused on generic drugs (n = 728, 62.1%). Multi-regional clinical trials (MRCTs) accounted for less than 6% of all trials. The number of trials on dermatology drugs increased sharply from 2016 to 2018 followed by a decline, which is mainly driven by the drop in bioequivalence evaluation (BE) studies for generic drugs indicated for skin infection. A growing trend in the number of trials for innovative drugs was observed. After removing duplicated drugs based on generic name, a total of 607 tested dermatology drugs were identified among which 51.9% were indicated for IMIDs. The number of innovative drugs exceeded generic drugs from 2020 to 2022. The geographic distribution of lead sites (the site where the principal investigator being employed) was uneven, with most of them located in east China. Of 1,068 trials sponsored by Chinese firms, most were BE (n = 692, 64.8%) and generic drugs (n = 722, 67.6%), while among 104 trials sponsored by multinational corporations (MNC), a majority were phase III (n = 53, 51.0%) trials and focused on innovative drugs (n = 94, 90.4%).

conclusionFindings demonstrated positive consequences of reforms in the healthcare industry in China. Nevertheless, long-term policies are expected to enhance the innovative capabilities of Chinese pharmaceutical companies while ensuring accessible and affordable drug supply with generics, encourage early participation in global drug R&D activities to shorten "drug lag", and promote investment in innovative drugs.

Indexed as

Clinical Trials as TopicDermatologic AgentsSkin DiseasesChinaHumansDermatologic AgentsClinical trialDermatological diseaseDermatological drugPipelineResearch and developmentSkin disease

Identifiers

PMID39948234

What OpenQuestion holds

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Registered trials

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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.