Research Articles
Navigating Patient Reconsent: A Strategic Guide for Managing Protocol Amendments in Clinical Trials
This article provides clinical researchers and drug development professionals with a comprehensive framework for managing the patient reconsent process following protocol changes.
The High Price of Change: Quantifying and Controlling Protocol Amendment Costs in Clinical Trials
Protocol amendments are a pervasive and costly reality in clinical development, with recent data indicating 76% of trials require them at a direct cost of up to $535,000 each.
Protocol Resilience: Data-Driven Strategies to Minimize Costly Clinical Trial Amendments
Clinical trial protocol amendments are a major source of delay and cost, with recent data indicating 76% of trials require them, at an average cost of over $500,000 per amendment.
Navigating IRB Amendment Applications: A Researcher's Guide to Avoiding Common Problems and Delays
This guide provides researchers, scientists, and drug development professionals with a comprehensive framework for successfully navigating the Institutional Review Board (IRB) amendment process.
Preventing IRB Amendment Delays: A Strategic Guide for Researchers and Clinical Trial Professionals
This article provides a comprehensive guide for researchers, scientists, and drug development professionals to navigate the Institutional Review Board (IRB) amendment process efficiently.
Managing Multiple Protocol Versions Across Sites: A Strategic Guide for Clinical Trial Efficiency
This article provides a comprehensive guide for researchers, scientists, and drug development professionals on navigating the complexities of managing multiple protocol versions across clinical trial sites.
Strategic Protocol Design: A Guide to Reducing Avoidable Amendments and Cutting Clinical Trial Costs
This article provides a comprehensive guide for researchers and drug development professionals on minimizing costly and time-consuming clinical trial protocol amendments.
Protocol Amendments and Consent Form Updates: A Strategic Guide for Clinical Researchers
This article provides a comprehensive guide for researchers, scientists, and drug development professionals on managing informed consent form updates following protocol amendments.
Navigating IRB Expedited Review for Minor Changes: A Researcher's Guide to Efficient Protocol Modifications
This article provides a comprehensive guide for researchers and drug development professionals on leveraging expedited IRB review for minor changes to approved studies.
New Protocol vs. Amendment: A Strategic Guide to Faster IRB Approval and Efficient Study Design
This article provides a comprehensive decision-making framework for researchers and drug development professionals navigating the critical choice between submitting a new study protocol or amending an existing one.