Trusted Resource for Clinical Trials, Protocols & Progress
Data Lock and Database Finalization in Phase 3 Clinical Trials: Workflow, Compliance, and Best Practices How to Manage Data Lock and Finalize Databases in Phase 3 Trials What Is Data Lock in Clinical Trials? Data lock (also called “database lock”) is the formal, irreversible process of closing the clinical database for statistical analysis after all…
Phase 2 Trial Designs for Special Populations (Elderly, Pediatric, Renal, Hepatic Impairment) Designing Phase 2 Trials for Special Populations: Elderly, Pediatric, Renal, and Hepatic Impairment Introduction While Phase 2 trials traditionally focus on efficacy and dose optimization in adult patients, modern regulatory science increasingly demands evaluation in special populations early in the drug development process….
Drug-Drug Interaction (DDI) Studies in Phase 1: Design and Regulatory Strategy Drug-Drug Interaction (DDI) Studies in Phase 1: Design and Regulatory Strategy Introduction Drug-drug interactions (DDIs) represent a major challenge in clinical pharmacology, especially during the early development phase. In Phase 1 trials, understanding how a new investigational product (IP) behaves when co-administered with other…
Read More “Drug-Drug Interaction (DDI) Studies in Phase 1: Design and Regulatory Strategy” »
PET Imaging and Radiolabeling Techniques in Phase 0 Oncology Studies Using PET Imaging and Radiolabeling in Phase 0 Oncology Trials Introduction Phase 0 oncology trials aim to generate early human data to guide therapeutic development. One of the most powerful tools in these trials is Positron Emission Tomography (PET) imaging, especially when paired with radiolabeled…
Read More “PET Imaging and Radiolabeling Techniques in Phase 0 Oncology Studies” »
Electronic Health Records (EHR) and Claims Data in Phase 4 Clinical Trials: Unlocking Real-World Insights How EHR and Claims Data Transform Phase 4 Clinical Research and Post-Marketing Surveillance Introduction: The Power of Real-World Data in Phase 4 Once a drug is approved and enters the market, real-world data (RWD) becomes central to understanding its long-term…
Retention Strategies and Reducing Dropouts in Phase 3 Trials: Tools, Tactics, and Real-World Practices How to Keep Patients Engaged and Reduce Dropouts in Phase 3 Clinical Trials Why Retention Is Crucial in Phase 3 Clinical Trials Patient retention in Phase 3 trials is just as important as recruitment. A dropout can lead to incomplete data,…
Surrogate Endpoints and Their Regulatory Acceptance Understanding Surrogate Endpoints in Phase 2 Trials and Their Regulatory Acceptance Introduction In drug development, especially during Phase 2 clinical trials, time and precision are crucial. One way to accelerate development and assess early drug efficacy is through the use of surrogate endpoints. These are indirect measures that substitute…
Read More “Surrogate Endpoints and Their Regulatory Acceptance” »
Special Populations in Phase 1: Elderly, Renal Impairment, and Hepatic Dysfunction Special Populations in Phase 1: Elderly, Renal Impairment, and Hepatic Dysfunction Introduction While early-phase clinical trials typically involve healthy adult volunteers, Phase 1 studies sometimes need to assess how drugs behave in special populations, including the elderly, patients with renal impairment, and those with…
Read More “Special Populations in Phase 1: Elderly, Renal Impairment, and Hepatic Dysfunction” »
Label Expansion and New Indications via Phase 4 Clinical Trials How Phase 4 Trials Support Regulatory Approvals for New Indications and Label Changes Why Label Expansion Happens in Phase 4 Approval of a new drug is just the beginning of its lifecycle. In many cases, further data collected during Phase 4 clinical trials provides the…
Read More “Label Expansion and New Indications via Phase 4 Clinical Trials” »
Common Pitfalls in Phase 0 Trial Design and How to Avoid Them Common Pitfalls in Phase 0 Trial Design and How to Avoid Them Introduction Phase 0 trials are small, fast, and cost-effective—but they must be carefully designed to yield meaningful data. Because these microdosing studies are non-therapeutic, researchers sometimes underestimate their complexity. Design missteps…
Read More “Common Pitfalls in Phase 0 Trial Design and How to Avoid Them” »
