Skip to content
Clinical Research Made Simple

Clinical Research Made Simple

Trusted Resource for Clinical Trials, Protocols & Progress

Tag: group

Regulatory Requirements for Group Comparisons – Clinical Trial Design and Protocol Development

Posted on June 12, 2025 digi By digi

Regulatory Requirements for Group Comparisons – Clinical Trial Design and Protocol Development “Rules and Regulations for Comparing Groups” Introduction Group comparisons in clinical studies are an essential aspect of pharmaceutical research and development. They enable researchers to measure the efficacy and safety of new drugs by comparing different groups of subjects. However, these comparisons must…

Read More “Regulatory Requirements for Group Comparisons – Clinical Trial Design and Protocol Development” »

Clinical Trial Design and Protocol Development, Parallel Group Designs

Sample Size Calculation for Parallel Group Studies – Clinical Trial Design and Protocol Development

Posted on June 8, 2025 digi By digi

Sample Size Calculation for Parallel Group Studies – Clinical Trial Design and Protocol Development “Calculating Sample Size for Parallel Group Research” Introduction to Sample Size Calculation for Parallel Group Studies Sample size calculation is a critical step in the planning of clinical trials, including parallel group studies. The sample size has a significant impact on…

Read More “Sample Size Calculation for Parallel Group Studies – Clinical Trial Design and Protocol Development” »

Clinical Trial Design and Protocol Development, Parallel Group Designs

Advantages and Limitations of Parallel Group Trials – Clinical Trial Design and Protocol Development

Posted on June 7, 2025 digi By digi

Advantages and Limitations of Parallel Group Trials – Clinical Trial Design and Protocol Development “Benefits and Challenges of Parallel Group Trials” Introduction Parallel group trials are a common feature in clinical studies. They are an essential aspect of clinical trials that help to determine the efficacy and safety of new interventions. In this article, we…

Read More “Advantages and Limitations of Parallel Group Trials – Clinical Trial Design and Protocol Development” »

Clinical Trial Design and Protocol Development, Parallel Group Designs

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
    • U.S. FDA Regulations
    • CDSCO (India) Guidelines
    • EMA (European Medicines Agency) Guidelines
    • PMDA (Japan) Guidelines
    • MHRA (UK) Guidelines
    • TGA (Australia) Guidelines
    • Health Canada Guidelines
    • WHO Guidelines
    • ICH Guidelines
    • ASEAN Guidelines
  • Clinical Trial Design and Protocol Development
    • Randomized Controlled Trials (RCTs)
    • Adaptive Trial Designs
    • Crossover Trials
    • Parallel Group Designs
    • Factorial Designs
    • Cluster Randomized Trials
    • Single-Arm Trials
    • Open-Label Studies
    • Blinded Studies (Single, Double, Triple)
    • Non-Inferiority and Equivalence Trials
    • Randomization Techniques in Crossover Trials
  • Good Clinical Practice (GCP) and Compliance
    • GCP Training Programs
    • ICH-GCP Compliance
    • GCP Violations and Audit Responses
    • Monitoring Plans
    • Investigator Responsibilities
    • Sponsor Responsibilities
    • Ethics Committee Roles

Menu

Recent Posts

  • Regulatory Requirements for Group Comparisons – Clinical Trial Design and Protocol Development
  • Cardiac Safety in Phase 1: QTc and Intensive ECG Monitoring
  • Endpoint Hierarchy Planning and Sensitivity Analyses in Phase 3 Trials: Ensuring Statistical Validity and Regulatory Confidence
  • Data Mining for Adverse Drug Reactions in Phase 4 Clinical Trials
  • Examples of Parallel Designs in Oncology Trials – Clinical Trial Design and Protocol Development

Copyright © 2025 Clinical Research Made Simple.

Powered by PressBook WordPress theme