Tag: clinical trial phase ethics

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

Posted on digi By digi

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…

Read More “Step-by-Step Guide to Regulatory Submissions for Phase 0 Trials” »

Phase 0 (Microdosing Studies)

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

Posted on digi By digi

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…

Read More “Real-World Evidence (RWE) Generation from Phase 4 Clinical Trials” »

Phase 4 (Post-Marketing Surveillance)

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

Posted on digi By digi

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…

Read More “Global Phase 3 Trial Design: Conducting Multi-Regional Clinical Trials (MRCTs)” »

Phase 3 (Confirmation and Monitoring)

Dose-Ranging and Dose-Finding Strategies in Phase 2

Posted on digi By digi

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…

Read More “Dose-Ranging and Dose-Finding Strategies in Phase 2” »

Phase 2 (Efficacy and Side Effects)

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

Posted on digi By digi

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…

Read More “Sentinel Dosing in First-in-Human Studies: Why and How It’s Done” »

Phase 1 (Safety and Dosage)

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

Posted on digi By digi

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…

Read More “Post-Marketing Commitments and Post-Authorization Safety Studies (PASS) in Phase 4 Trials” »

Phase 4 (Post-Marketing Surveillance)

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

Posted on digi By digi

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…

Read More “Ethics and Safety in Phase 0 Trials: What You Need to Know” »

Phase 0 (Microdosing Studies)

Adaptive Designs in Phase 2: Interim Analyses and Seamless Designs

Posted on digi By digi

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…

Read More “Adaptive Designs in Phase 2: Interim Analyses and Seamless Designs” »

Phase 2 (Efficacy and Side Effects)

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

Posted on digi By digi

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…

Read More “Endpoint Selection in Phase 3 Trials: Understanding Primary and Secondary Endpoints” »

Phase 3 (Confirmation and Monitoring)

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

Posted on digi By digi

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…

Read More “Dose Escalation Designs in Phase 1: 3+3, BOIN, mTPI, CRM Explained” »

Phase 1 (Safety and Dosage)