ArticleClinical and translational science2017
The Burden of the "False-Negatives" in Clinical Development: Analyses of Current and Alternative Scenarios and Corrective Measures.
Article in Clinical and translational science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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
20 citing papers in PubMed.
- Powering Neurology Drug Development Trials to Reduce False Negative Results.Clinical and translational science · 2026Review
- Updated evidence on the accuracy ofQuantitative imaging in medicine and surgery · 2026Review
- Quo Vadis translational neuroscience?Translational neuroscience · 2026Review
- Toward Standardized Methodologies for Drug-Induced Proarrhythmia Classification: An In Silico Proof of Concept.Computational and structural biotechnology journal · 2026Article
- Article
- A review of machine learning applications in heart health.Biomedical engineering online · 2025Review
- Enhancing the Predictions of Cytomegalovirus Infection in Severe Ulcerative Colitis Using a Deep Learning Ensemble Model: Development and Validation Study.JMIR medical informatics · 2025Article
- Machine Learning Approach with Harmonized Multinational Datasets for Enhanced Prediction of Hypothyroidism in Patients with Type 2 Diabetes.Diagnostics (Basel, Switzerland) · 2024Article
- Aetiologies of bacterial tick-borne febrile illnesses in humans in Africa: diagnostic limitations and the need for improvement.Frontiers in medicine · 2024Review
- DRAVA: Aligning Human Concepts with Machine Learning Latent Dimensions for the Visual Exploration of Small Multiples.Proceedings of the SIGCHI conference on human factors in computing systems. CHI Conference · 2023Article
- A critical scientific evaluation of a purportedly negative data report - response to Seneviratne et al. 2022.Frontiers in psychiatry · 2023Article
- Abdominal Aortic Thrombus Segmentation in Postoperative Computed Tomography Angiography Images Using Bi-Directional Convolutional Long Short-Term Memory Architecture.Sensors (Basel, Switzerland) · 2022Article
- Scoping Review on the Multimodal Classification of Depression and Experimental Study on Existing Multimodal Models.Diagnostics (Basel, Switzerland) · 2022Article
- Strategic, feasibility, economic, and cultural aspects of phase 0 approaches: Is it time to change the drug development process in order to increase productivity?Clinical and translational science · 2022Review
- Automatic Detection and Segmentation of Thrombi in Abdominal Aortic Aneurysms Using a Mask Region-Based Convolutional Neural Network with Optimized Loss Functions.Sensors (Basel, Switzerland) · 2022Article
- Sample Adequacy Control (SAC) Lowers False Negatives and Increases the Quality of Screening: Introduction of "Non-Competitive" SAC for qPCR Assays.Diagnostics (Basel, Switzerland) · 2021Article
- Phase 0/microdosing approaches: time for mainstream application in drug development?Nature reviews. Drug discovery · 2020Review
- How technical progress reshaped behavioral neuroendocrinology during the last 50 years… and some methodological remarks.Hormones and behavior · 2020Review
- Statistical Accuracy in Rheumatology Research.Mediterranean journal of rheumatology · 2019Review
- Comparison of the cohort selection performance of Australian Medicines Terminology to Anatomical Therapeutic Chemical mappings.Journal of the American Medical Informatics Association : JAMIA · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
The "false-negatives" of clinical development are the effective treatments wrongly determined ineffective. Statistical errors leading to "false-negatives" are larger than those leading to "false-positives," especially in typically underpowered early-phase trials. In addition, "false-negatives" are usually eliminated from further testing, thereby limiting the information available on them. We simulated the impact of early-phase power on economic productivity in three developmental scenarios. Scenario 1, representing the current status quo, assumed 50% statistical power at phase II and 90% at phase III. Scenario 2 assumed increased power (80%), and Scenario 3, increased stringency of alpha (1%) at phase II. Scenario 2 led, on average, to a 60.4% increase in productivity and 52.4% increase in profit. Scenario 3 had no meaningful advantages. Our results suggest that additional costs incurred by increasing the power of phase II studies are offset by the increase in productivity. We discuss the implications of our results and propose corrective measures.
Indexed as
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.