ArticleEClinicalMedicine2023
Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022.
Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Comparison of treatment efficacy of targeted therapies approved in China for non-small cell lung cancer before and after the introduction of accelerated drug marketing registration procedures.International journal of clinical pharmacy · 2026Pooled it
- Regulatory and clinical outcomes of priority-reviewed innovative cancer drugs in China between 2015 and 2024: an observational study.BMC cancer · 2025Pooled it
- Baduanjin exercise for negative emotion of patients undergoing chemotherapy: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Pooled it
- Design Characteristics and Survival Outcomes of Local Trials Supporting the Approval of Targeted Anticancer Drugs in China.Cancer medicine · 2026Article
- Clinical value and cost-effectiveness analysis of conditionally approved anticancer drugs in China from 2015 to 2023.Translational cancer research · 2026Article
- Comparison of the conditional approvals for anticancer drugs supported by single-arm trials in China and the United States: clinical evidence, post-marketing requirements, and regulatory outcomes.Frontiers in pharmacology · 2026Article
- Trends, lag and characteristics of rare disease drug approval in the USA and China, 1983-2022.Orphanet journal of rare diseases · 2025Article
- Quality of Drug Clinical Trials in China: A Mixed Methods Research.Journal of evidence-based medicine · 2025Article
- Comparative Assessment of Pivotal Trials Supporting the Indication Approvals of Innovative and Modified New Anticancer Drugs in China, 2016-2022.Health data science · 2025Article
- Response to "Anticancer Drug Approval in China: From Acceleration of Access to Certainty of Benefits".Health data science · 2025Article
- Characteristics, clinical evidence and implementation effects of conditional approvals for drugs in China, a pooled analysis from 2020 to 2023.Frontiers in pharmacology · 2025Article
- Confirmatory Trials for Drugs Granted Conditional Approval by the Chinese National Medical Products Administration.JAMA health forum · 2024Article
- Progress and challenges of confirmatory trials for cancer drugs granted conditional approval in China.The Lancet regional health. Western Pacific · 2024Article
- Clinical Benefit, Price, and Regulatory Approval of Cancer Drugs Granted Breakthrough Therapy Designation in China, 2020-2024.JAMA network open · 2024Article
- Assessment of clinical benefit, cost and uptake of biosimilars versus reference biologics in immune-mediated inflammatory diseases in China.Frontiers in public health · 2024Article
- Single-arm trials for domestic oncology drug approvals in China.Cancer biology & medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Accelerated approval (AA) of novel anticancer drugs based on surrogacy has attracted considerable concern globally. China National Medical Products Administration (NMPA) also established a similar conditional approval (CA) program to accelerate the approval of novel drugs to address unmet medical needs. This cross-sectional study aimed to evaluate the pre-approval clinical trial evidence and potential challenge of cancer drugs receiving CA in China from policy implementation to 2022. Methods: The cancer drugs (initial and supplemental indications) granted CA between January 1, 2015 and December 31, 2022 using the public database of the NMPA were analyzed. The characteristics of the cancer drugs received CA were described. Primary efficacy endpoints and safety derived from the pre-approval clinical trial, including response rates (RR), progression-free survival (PFS), overall survival (OS), treatment-related serious adverse events (SAE) and Grade ≥3 adverse events (AEs) were quantitatively estimated by meta-analysis. Besides, the correlation between the surrogate endpoints and OS was estimated by the reported trial-level correlation analysis. Findings: The NMPA approved 72 cancer indications (56 new molecular entities) with CA between 2015 and 2022. 34 indications (47%) were also approved by the FDA or EMA. 74% (53/72) of cancer indications were based on a single-arm trial design while 26% (19/72) for randomized controlled trials. The pooled RR was 0.50 (95% CI: 0.45-0.55, Interpretation: The majority of novel cancer drugs that received CA were based on RR designed for single-arm trials. The reported correlations of treatment effect between the surrogate endpoints and OS used for CA were limited. Our findings highlighted that the introduction of OS or quality of life based on RCT in confirmatory clinical trials as much as feasible was essential to ensure the clinical benefits for patients. Funding: This study was supported by postdoctoral fellowship from Tsinghua-Peking Joint Centers for Life Sciences (CLS).
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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.