Bringing a new drug to market takes pharmaceutical companies 10 to 15 years and more than $2.3 billion; still, 90% of clinical trials fail. The validity of clinical trials is crucial for their success and for their results to be relevant and meaningful for patients in real-world settings. However, efficacy and safety concerns, inclusion/exclusion issues, patient recruitment, and rising scrutiny from the FDA are common obstacles.
Successful trials must employ good study design, select relevant endpoints, use valid assessment tools, effectively recruit study participants, and ensure data quality and validity. Technology, such as AI, is being used to speed up patient recruitment and potentially predict dropout rates, helping pick the best study design. Choosing validated and reliable outcome assessments is crucial to ensure accurate data.
However, failure in recruitment and issues like mistrust in research and lack of logistics can hinder a trial’s completion. High-quality data collection, providing standardization education, and real-time data collection can improve the chances of positive trial outcomes. It’s underlined that anyone involved in clinical trial research should comply with the highest possible standards.
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[Source: BioPharma Dive, October 16th, 2023]