Trusted Resource for Clinical Trials, Protocols & Progress
Sample Size Calculation for Phase 2 Trials How to Calculate Sample Size for Phase 2 Clinical Trials Introduction Determining the appropriate sample size in a Phase 2 clinical trial is a critical step that directly affects the trial’s ability to detect meaningful treatment effects, avoid underpowered results, and prevent unnecessary exposure of patients to experimental…
Phase 1 Studies for Biosimilars: PK, PD, and Immunogenicity Assessment Designing Biosimilar Phase 1 Trials: PK, PD, and Immunogenicity Considerations Introduction Biosimilars—biologic products that are highly similar to an approved reference product—must undergo rigorous evaluation to demonstrate similarity in structure, function, and clinical performance. Phase 1 clinical trials are a cornerstone of biosimilar development and…
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Economic Outcomes and Cost-Effectiveness in Phase 4 Clinical Trials Measuring Cost-Effectiveness and Economic Value in Phase 4 Research Introduction: Why Economic Data Matters in Phase 4 Once a drug enters the market, its clinical benefit must translate into real-world value—not only in health outcomes but also in terms of cost and resource use. That’s where…
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Recruitment and Retention Strategies in Phase 2 Effective Strategies for Patient Recruitment and Retention in Phase 2 Clinical Trials Introduction Phase 2 clinical trials are critical for evaluating a drug’s efficacy, refining dosage, and identifying early safety signals. Yet, one of the most common reasons for delays and failures in Phase 2 is poor patient…
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Labeling Negotiations and Risk Communication After Phase 3 Trials: Process, Stakeholders, and Best Practices How Drug Labeling and Risk Communication Are Finalized After Phase 3 Trials Why Labeling and Risk Communication Matter Post Phase 3 After a Phase 3 trial concludes and a regulatory submission is underway, a crucial next step is product labeling. The…
Early Stopping Rules in Phase 1 Trials: Safety, PK, and Futility Criteria Understanding When to Stop: Defining Early Termination Criteria in Phase 1 Trials Introduction Phase 1 clinical trials are designed to explore safety, pharmacokinetics (PK), and tolerability of a new investigational drug. Given the first-in-human exposure and potential unknown risks, early stopping rules are…
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Phase 4 Trials in Vaccine Safety Monitoring: Ensuring Public Trust Through Real-World Surveillance How Phase 4 Clinical Trials Safeguard Vaccine Safety After Approval Introduction: Why Vaccine Safety Monitoring Doesn’t End at Approval Vaccines are among the most effective public health tools, yet they are administered to healthy populations—including children, the elderly, and immunocompromised individuals. This…
Real-World Data (RWD) Integration into Phase 2 Design and Interpretation Integrating Real-World Data (RWD) into Phase 2 Trial Design and Interpretation Introduction As the clinical research landscape evolves, the role of Real-World Data (RWD) is expanding beyond post-marketing surveillance into earlier stages of development—including Phase 2 trials. RWD sources like electronic health records, insurance claims,…
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Global Regulatory Variations in Accepting Phase 3 Data: Guidelines, Differences, and Submission Strategies How Regulatory Agencies Differ in Accepting Phase 3 Clinical Trial Data Worldwide Why Global Regulatory Alignment Matters After Phase 3 Phase 3 clinical trials are often conducted as multi-regional studies with the goal of gaining approval in multiple countries. However, each regulatory…
Sentinel Dosing Strategy in First-in-Human Trials Using Sentinel Subjects to Improve Safety in First-in-Human Dose Escalation Trials Introduction First-in-Human (FIH) clinical trials are among the most critical and high-risk stages in drug development. At this point, investigational drugs are administered to humans for the first time, often based only on preclinical data. To mitigate unforeseen…
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