Trusted Resource for Clinical Trials, Protocols & Progress
Post-Marketing Commitments and Post-Authorization Safety Studies (PASS) in Phase 4 Trials Understanding PMCs and PASS in Phase 4 Clinical Trials: Compliance and Design Essentials What Are Post-Marketing Commitments and PASS? After a new drug or biologic is approved, regulatory agencies often require further studies to confirm its long-term safety, effectiveness, or optimal usage. These obligations…
Ethics and Safety in Phase 0 Trials: What You Need to Know Ethics and Safety in Phase 0 Trials: What Every Researcher Should Know Introduction: Ethics at the Heart of Human Research Even though Phase 0 trials involve microdoses and no therapeutic intent, they are still clinical trials involving human participants. This means they must…
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Adaptive Designs in Phase 2: Interim Analyses and Seamless Designs Understanding Adaptive Designs in Phase 2 Trials: Interim Analyses and Seamless Strategies Introduction As clinical development becomes more resource-intensive, there is a growing need for flexible and efficient trial methodologies. Adaptive designs in Phase 2 clinical trials offer the ability to make pre-specified modifications to…
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Endpoint Selection in Phase 3 Trials: Understanding Primary and Secondary Endpoints How to Choose Primary and Secondary Endpoints in Phase 3 Clinical Trials What Are Endpoints in Clinical Trials? Endpoints are the measurable outcomes that determine whether a clinical trial’s objectives are achieved. In Phase 3 trials, endpoint selection is one of the most critical…
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Dose Escalation Designs in Phase 1: 3+3, BOIN, mTPI, CRM Explained Dose Escalation Designs in Phase 1 Trials: 3+3, BOIN, mTPI, and CRM Explained Introduction In Phase 1 clinical trials, dose escalation is a critical step in determining the maximum tolerated dose (MTD) or identifying a biologically effective dose. The design you choose directly influences…
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Randomized Controlled Phase 2 Trials: Pros and Cons Evaluating the Pros and Cons of Randomized Controlled Trials in Phase 2 Introduction Randomized controlled trials (RCTs) are often considered the gold standard in clinical research due to their ability to minimize bias and provide high-quality evidence. In Phase 2 clinical trials, where the goal is to…
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Comparative Effectiveness Research in Phase 4 Clinical Trials: Real-World Value Assessment How Phase 4 Trials Enable Comparative Effectiveness Research in Real-World Settings What Is Comparative Effectiveness Research (CER)? Comparative Effectiveness Research (CER) refers to the direct comparison of different treatment options to evaluate which works best for specific populations or under real-world conditions. In Phase…
Statistical Considerations and Sample Size Justification in Phase 3 Clinical Trials How to Plan Statistical Parameters and Sample Size in Phase 3 Trials Why Statistical Planning is Crucial in Phase 3 Trials Statistical considerations are the backbone of any well-designed Phase 3 clinical trial. These trials are the final stage before regulatory approval, so every…
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Selecting the Right Candidates for Phase 0: Drug Selection Criteria How to Choose the Right Drug Candidates for Phase 0 Clinical Trials Why Drug Selection Matters in Phase 0 Trials Not every drug candidate is suitable for a Phase 0 microdosing study. These trials are designed to generate early pharmacokinetic (PK) and pharmacodynamic (PD) data…
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Determining the Starting Dose for First-in-Human Trials (MABEL, NOAEL, BSA) Determining the Starting Dose for First-in-Human Trials: MABEL, NOAEL, and BSA Explained Introduction In first-in-human (FIH) trials, selecting the initial dose is one of the most important and scrutinized decisions. Too high, and you risk harm to participants. Too low, and the data may be…
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