SynthesisDrug design, development and therapy2015
Sample sizes in dosage investigational clinical trials: a systematic evaluation.
Synthesis in Drug design, development and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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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.
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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.
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Who cites it
15 citing papers in PubMed.
- First-line PD-1/VEGF bispecific antibody plus chemotherapy in triple-negative breast cancer: a phase 2 trial.Nature medicine · 2026Trial
- Speech treatment in Parkinson's disease: Randomized controlled trial (RCT).Movement disorders : official journal of the Movement Disorder Society · 2018Trial
- Letter to the Editor: Can upadacitinib dose escalation redefine treatment strategies in refractory inflammatory bowel disease?World journal of gastrointestinal pharmacology and therapeutics · 2026Article
- Article
- Article
- Evolution of Clinical Trials of Systemic Therapies for Hepatocellular Carcinoma Between 2005 and 2024: Based on ClinicalTrials.gov.Gastro hep advances · 2025Review
- Characteristic analysis of clinical trials for new traditional Chinese medicines in mainland China from 2013 to 2021.Frontiers in medicine · 2022Review
- Noninvasive wearable electroactive pharmaceutical monitoring for personalized therapeutics.Proceedings of the National Academy of Sciences of the United States of America · 2020Article
- Study Design Characteristics and Pharmacological Mechanisms in International Clinical Trials Registry Platform: Registered Clinical Trials on Antiviral Drugs for COVID-19.Drug design, development and therapy · 2020Review
- Characteristics of COVID-19 Clinical Trials in China Based on the Registration Data on ChiCTR and ClinicalTrials.gov.Drug design, development and therapy · 2020Review
- Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations.Clinical and translational science · 2019Article
- Association of HLA-DQA1 gene polymorphisms with the risk of children primary nephrotic syndrome in Chinese population.Journal of clinical laboratory analysis · 2019Article
- Therapeutic potential of combined viral transduction and CRISPR/Cas9 gene editing in treating neurodegenerative diseases.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018Review
- Inhaled corticosteroids in ventilated preterm neonates: a non-randomized dose-ranging study.BMC pediatrics · 2018Article
- Mesenchymal stem cell therapy in retinal and optic nerve diseases: An update of clinical trials.World journal of stem cells · 2016Review
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The main purpose of investigational phase II clinical trials is to explore indications and effective doses. However, as yet, there is no clear rule and no related published literature about the precise suitable sample sizes to be used in phase II clinical trials. To explore this, we searched for clinical trials in the ClinicalTrials.gov registry using the keywords "dose-finding" or "dose-response" and "Phase II". The time span of the search was September 20, 1999, to December 31, 2013. A total of 2103 clinical trials were finally included in our review. Regarding sample sizes, 1,156 clinical trials had <40 participants in each group, accounting for 55.0% of the studies reviewed, and only 17.2% of the studies reviewed had >100 patient cases in a single group. Sample sizes used in parallel study designs tended to be larger than those of crossover designs (median sample size 151 and 37, respectively). In conclusion, in the earlier phases of drug research and development, there are a variety of designs for dosage investigational studies. The sample size of each trial should be comprehensively considered and selected according to the study design and purpose.
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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.