Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions and now in clinical trial designs. The gold standard for demonstrating the efficacy of clinical trials since the 1960s has been randomized controlled trials (RCTs). We require at least two pivotal RCTs on the market for investigational medications. RCTs […]

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Sponsors and CROs are preparing to conduct more hybrid clinical trials than traditional site-based trials, marking a turning point for the industry. A poll found that 77 percent of clinical trial executives planned to perform hybrid trials next year, up from 59 percent the year before. Hybrid clinical trial models have their roots in decentralized […]

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To make a clinical trial faster, cost-efficient, and more successful, it all starts with a strategic design of a clinical trial, and the sturdy trial design is essential to ensure a successful clinical outcome. A proper study design determines the fate of the clinical trial and its likeliness to be successful. A study design involves […]

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