Skip to content
Clinical Research Made Simple

Clinical Research Made Simple

Trusted Resource for Clinical Trials, Protocols & Progress

Tag: clinical trial methodologies

Crossover Trials in Clinical Research: Design, Methodology, and Best Practices

Posted on May 14, 2025 digi By digi

Crossover Trials in Clinical Research: Design, Methodology, and Best Practices Comprehensive Overview of Crossover Trials in Clinical Research Crossover trials are a distinctive clinical study design where participants receive multiple interventions sequentially, serving as their own control. By minimizing inter-subject variability, crossover designs enhance statistical efficiency and reduce required sample sizes, making them particularly attractive…

Read More “Crossover Trials in Clinical Research: Design, Methodology, and Best Practices” »

Clinical Trial Design and Protocol Development, Crossover Trials

Single-Arm Trials: Design, Applications, and Best Practices in Clinical Research

Posted on May 8, 2025 digi By digi

Single-Arm Trials: Design, Applications, and Best Practices in Clinical Research Comprehensive Overview of Single-Arm Trials in Clinical Research Single-arm trials (SATs) offer a pragmatic design for evaluating the efficacy and safety of interventions when randomized controls are impractical, unethical, or infeasible. Especially prominent in oncology, rare diseases, and early-phase drug development, single-arm designs enable rapid…

Read More “Single-Arm Trials: Design, Applications, and Best Practices in Clinical Research” »

Clinical Trial Design and Protocol Development, Single-Arm Trials

Quick Guide

  • Clinical Trial Phases
    • Preclinical Studies
    • Phase 0 (Microdosing Studies)
    • Phase 1 (Safety and Dosage)
    • Phase 2 (Efficacy and Side Effects)
    • Phase 3 (Confirmation and Monitoring)
    • Phase 4 (Post-Marketing Surveillance)
  • Regulatory Guidelines
  • Clinical Trial Design and Protocol Development
  • Good Clinical Practice (GCP) and Compliance
  • U.S. FDA Regulations

Menu

Recent Posts

  • Stopping Rules and Dose Limiting Toxicity (DLT) Criteria in Phase 1 Trials
  • Data Collection Tools and eCRFs in Phase 3 Clinical Trials: Best Practices and Regulatory Insights
  • Safety Monitoring Requirements in Phase 2 Trials
  • Bioanalytical Methods and Assay Development for Microdose Studies
  • Long-Term Safety Monitoring Protocols in Phase 4 Clinical Trials

Copyright © 2025 Clinical Research Made Simple.

Powered by PressBook WordPress theme