GuidelineCancer science2021
Guidelines for clinical evaluation of anti-cancer drugs.
Guideline in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis 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
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Guidelines for clinical evaluation of anti-cancer drugs.Cancer science · 2021Guideline
- Efficacy Endpoints in Phase II Clinical Trials for Meningioma: An Analysis of Recent Clinical Trials.Therapeutic innovation & regulatory science · 2023Trial
- A phase I/II study of 10-min dosing of bendamustine hydrochloride (rapid infusion formulation) in patients with previously untreated indolent B-cell non-Hodgkin lymphoma, mantle cell lymphoma, or relapsed/refractory diffuse large B-cell lymphoma in Japan.Cancer chemotherapy and pharmacology · 2022Trial
- Impact of Japanese Subpopulation Data and Overall Survival in Pivotal Trials on Oncology Drug Approvals in Japan.Therapeutic innovation & regulatory science · 2026Review
- Review
- Impurities in Oncology Pharmaceuticals: A Review of Classification, Detection Methods, Regulatory Frameworks and Emerging Trends.Therapeutic innovation & regulatory science · 2026Review
- Tolerability and safety of magrolimab (ONO-7913) in Japanese patients with advanced or metastatic solid tumors: a phase 1, open-label, uncontrolled, dose-escalation study.BMC research notes · 2026Article
- Computational Simulation of the Bioactivity of Selected Compounds Derived From the Sapium and Salvias Genera as Anticancer Agents.BioMed research international · 2026Article
- Identification and Description of Regulatory and Health Technology Assessment Agencies' Guidance Related to Patient Experience Data in North America, Europe, and Asia Pacific.Therapeutic innovation & regulatory science · 2025Article
- Dihydroartemisinin induces tumor suppression in the Drosophila brain tumor with functional recovery and a rescue in lethality.Scientific reports · 2025Article
- Trends in Efficacy Endpoints in Phase II Glioblastoma Trials: A Regulatory Science Analysis (FY2020-FY2022).Cancers · 2025Article
- Natural Anticancer Drugs: Efficacy, Safety, and Future Challenges.Current medicinal chemistry · 2025Review
- Cancer registry as external control data for regulatory submission in Japan.ESMO real world data and digital oncology · 2024Review
- Recent Status of Phase I Clinical Trials for Brain Tumors: A Regulatory Science Study of Exploratory Efficacy Endpoints.Therapeutic innovation & regulatory science · 2024Article
- Review
- Article
- Anticancer Drug Discovery Based on Natural Products: From Computational Approaches to Clinical Studies.Biomedicines · 2024Review
- Oncology drug lag in Japan: has it improved over the last decade?International journal of clinical oncology · 2023Article
- Comprehensive Analysis of Cuproptosis Genes and Identification of Cuproptosis Subtypes in Breast Cancer.Combinatorial chemistry & high throughput screening · 2023Article
- DNA Damage Clustering after Ionizing Radiation and Consequences in the Processing of Chromatin Breaks.Molecules (Basel, Switzerland) · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 10 institutions in 1 country.
Funding
Abstract
Clinical studies intended for regulatory approval must demonstrate the clinical benefits of the drug in a target population. Clinical development of a drug proceeds by stepwise clinical studies; after safety and pharmacokinetics are evaluated and the recommended dosage and administration are determined, efficacy and safety are evaluated in an exploratory manner, and finally clinical benefits are compared with conventional standard therapies. Guidelines for the clinical evaluation of anti-cancer drugs in Japan were established in 1991 and amended in 2006 after molecular-targeted drugs were introduced. Recent progress in the development of drugs acting on the immune system and cancer genomic medicine targeting rare but important molecular subtypes have altered the strategy for development of anti-cancer drugs. It is often difficult to conduct a confirmatory randomized controlled study using overall survival as the primary endpoint in rare molecular subtypes, and the primary evaluation of the efficacy of some drugs and subsequent approval is based on the tumor response. As conducting clinical studies for rare subtypes solely within Japan is difficult, drug development needs to be conducted within a global study. However, this requires robust monitoring to detect possible ethnic differences in pharmacokinetics and drug efficacy. Development using the conditional approval system for drugs enforced in 2020 may be considered, when clinical utility is evaluated based on surrogate endpoints. Because of these changes, we have revised the guidelines for the clinical evaluation of anti-cancer drugs in Japan. To promote global development of anti-cancer drugs involving Japan, the guidelines have been translated into English.
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Identifiers
What OpenQuestion holds
Registered trials
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.