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Sample Size Calculation for Parallel Group Studies – Clinical Trial Design and Protocol Development “Calculating Sample Size for Parallel Group Research” Introduction to Sample Size Calculation for Parallel Group Studies Sample size calculation is a critical step in the planning of clinical trials, including parallel group studies. The sample size has a significant impact on…
Operational Planning for Seamless Phase Transitions – Clinical Trial Design and Protocol Development “Efficient Operational Planning for Smooth Phase Changes” Introduction to Operational Planning in Clinical Studies Operational planning for seamless phase transitions in clinical studies is a critical process that ensures the smooth progression of a clinical trial from one phase to another. This…
Ethical Justification for Adaptive Modifications – Clinical Trial Design and Protocol Development “Moral Grounds for Adaptive Changes” Introduction In clinical research, adaptive modifications have become an increasingly significant tool. These modifications make a trial more flexible and efficient, potentially improving the delivered outcomes for patients. However, their implementation is not without ethical considerations. This article…
Regulatory Expectations for RCT Designs – Clinical Trial Design and Protocol Development “Guidelines for Designing Randomized Controlled Trials” Introduction Randomized Controlled Trials (RCTs) are fundamental in the clinical research sector, offering a robust method for evaluating the efficacy and safety of new medical interventions. However, the design and execution of these trials must adhere to…
Sample Size Determination for RCTs – Clinical Trial Design and Protocol Development “Determining the Sample Size for Randomized Controlled Trials” Introduction to Sample Size Determination for RCTs Randomized Controlled Trials (RCTs) are a cornerstone of clinical research, providing the gold standard for evaluating the efficacy of new treatments. A critical aspect of designing any RCT…
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Designing a Parallel RCT for Drug Efficacy Testing – Clinical Trial Design and Protocol Development “Creating a Parallel Randomized Controlled Trial for Testing Drug Effectiveness” Introduction Randomized Controlled Trials (RCTs) are considered the gold standard in medical research due to their ability to eliminate bias and provide unbiased results. A Parallel RCT is a type…
