Tag: clinical trial phase reporting

Step-by-Step Guide to Regulatory Submissions for Phase 0 Trials

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Step-by-Step Guide to Regulatory Submissions for Phase 0 Trials Step-by-Step Guide to Regulatory Submissions for Phase 0 Clinical Trials Introduction: Regulatory Oversight in Phase 0 Trials Phase 0 trials, although short and low-risk, are still governed by regulatory frameworks. Before starting human studies, sponsors must obtain authorization from national health authorities. This ensures that human…

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Phase 0 (Microdosing Studies)

Real-World Evidence (RWE) Generation from Phase 4 Clinical Trials

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Real-World Evidence (RWE) Generation from Phase 4 Clinical Trials How Phase 4 Trials Generate Real-World Evidence to Inform Clinical Practice and Policy What Is Real-World Evidence (RWE)? Real-World Evidence (RWE) refers to clinical evidence derived from the analysis of Real-World Data (RWD)—information collected from everyday medical practice, outside of controlled clinical trial settings. In Phase…

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Phase 4 (Post-Marketing Surveillance)

Global Phase 3 Trial Design: Conducting Multi-Regional Clinical Trials (MRCTs)

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Global Phase 3 Trial Design: Conducting Multi-Regional Clinical Trials (MRCTs) Planning and Executing Multi-Regional Clinical Trials in Phase 3 Studies What Are Multi-Regional Clinical Trials (MRCTs)? Multi-Regional Clinical Trials (MRCTs) are Phase 3 studies conducted simultaneously across multiple geographic regions. Their objective is to generate clinical evidence applicable to a global population, often to support…

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Phase 3 (Confirmation and Monitoring)

Dose-Ranging and Dose-Finding Strategies in Phase 2

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Dose-Ranging and Dose-Finding Strategies in Phase 2 How Dose-Ranging and Dose-Finding Strategies Shape Phase 2 Clinical Trials Introduction One of the most important objectives in a Phase 2 clinical trial is to identify the optimal dose of an investigational drug. This is done through well-structured dose-ranging and dose-finding studies that evaluate different dosage levels for…

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Phase 2 (Efficacy and Side Effects)

Sentinel Dosing in First-in-Human Studies: Why and How It’s Done

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Sentinel Dosing in First-in-Human Studies: Why and How It’s Done Sentinel Dosing in First-in-Human Studies: Why and How It’s Done Introduction Sentinel dosing is a critical risk mitigation strategy in first-in-human (FIH) clinical trials. It involves administering the investigational product (IP) to one or two participants before exposing additional volunteers to the same dose. This…

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Phase 1 (Safety and Dosage)

Post-Marketing Commitments and Post-Authorization Safety Studies (PASS) in Phase 4 Trials

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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…

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Phase 4 (Post-Marketing Surveillance)

Ethics and Safety in Phase 0 Trials: What You Need to Know

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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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Phase 0 (Microdosing Studies)

Adaptive Designs in Phase 2: Interim Analyses and Seamless Designs

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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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Phase 2 (Efficacy and Side Effects)

Endpoint Selection in Phase 3 Trials: Understanding Primary and Secondary Endpoints

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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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Phase 3 (Confirmation and Monitoring)

Dose Escalation Designs in Phase 1: 3+3, BOIN, mTPI, CRM Explained

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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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Phase 1 (Safety and Dosage)