Article

Protocol Complexity and Trial Failure: Predictive Modeling for Early Feasibility Assessment in Drug and Device Development

2025-08-27

Abstract excerpt

<title>Abstract</title> <p><bold>Background:</bold> Unplanned discontinuation of clinical trials can delay medical product development, waste resources, and reduce confidence in evidence generation. Many terminations result from design or feasibility issues that could be addressed earlier in the planning process. <bold>Purpose:</bold> To determine whether structured protocol features available at trial registrati...

Topics

Open a Topic to create a Post that cites this publication.

Identifiers and source

Literature Corpus work: 65716109-8ecc-52d6-a882-dfdc4315e4a7
DOI: 10.21203/rs.3.rs-7218992/v1

Open publication

Related research

Semantic proximity does not establish scientific evidence.

Click a neighbor to travelStep 1 · 12 closest

Protocol Complexity and Trial Failure: Predictive Modeling for Early Feasibility Assessment in Drug and Device DevelopmentDOI 10.21203/rs.3.rs-7218992/v1Read

Exploring scalable assessment methods for terminated trials in ClinicalTrials.gov: A cohort analysis of German and Californian trialsSemantic proximity Read

Approaches in Analyzing Predictors of Trial Failure: A Scoping Review and Meta-epidemiological studySemantic proximity Read

Calendar Period Estimation of Probabilities of Transition in Drug DevelopmentSemantic proximity Read

General Characteristics and Reasons for the Discontinuation of Drug Clinical Trials in Mainland ChinaSemantic proximity Read

Leveraging Machine Learning Models to Predict Probability of Technical and Regulatory SuccessSemantic proximity Read

Pharmaceutical Drug Lifecycle: A Comprehensive Scientific Review of Research and Development Phases, Attrition Rates, and Global DisparitiesSemantic proximity Read

The Current Landscape of Clinical TrialsSemantic proximity Read

Development of a Risk-tailored Approach and Dashboard for Efficient Management and Monitoring of Investigator-Initiated TrialsSemantic proximity Read

Finding Success in Clinical Trial Recruitment: A Trial Registry AnalysisSemantic proximity Read

Trials evaluating drug discontinuation: a scoping review sub-analysis focusing on outcomes and research questionsSemantic proximity Read

Characteristics of COVID-19-related Clinical Studies and Factors Affecting the Recruitment and Completeness: a Large Cross-sectional StudySemantic proximity Read

Zombie trials are often monocentric and cluster within fabricated evidence “factories”: a cohort study of 236 retracted randomized controlled trials with confirmed data fabricationSemantic proximity Read