Tag: Clinical Trial Phases clinical trial phases

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)

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)

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)

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)

Randomized Controlled Phase 2 Trials: Pros and Cons

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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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Phase 2 (Efficacy and Side Effects)

Selecting the Right Candidates for Phase 0: Drug Selection Criteria

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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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Phase 0 (Microdosing Studies)

Determining the Starting Dose for First-in-Human Trials (MABEL, NOAEL, BSA)

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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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Phase 1 (Safety and Dosage)

Common Study Designs in Phase 2 Trials

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Common Study Designs in Phase 2 Trials Exploring Common Study Designs Used in Phase 2 Clinical Trials Introduction Phase 2 clinical trials are designed to evaluate whether a new therapeutic candidate is effective in a specific patient population. Since these trials follow the safety-focused Phase 1 stage, the emphasis shifts toward efficacy assessment, dose optimization,…

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Phase 2 (Efficacy and Side Effects)