Insufficient enrollment in clinical trials continues to be a problem. Analysis of the factors limiting enrollment in clinical trials is vital for improving the studies’ design. Some of these factors are beyond our ability to influence them, such as problems with transportation and travel distance or insurance issues. At the same time, we have seen a significant increase in the number of inclusion and exclusion criteria. The median number of exclusion criteria for lung cancer studies has risen in recent decades from 16 during 1986-1995 to 27 during 2006-2016 [52].
Based on PSI CRO’s experience with more than 25 Phase 2 and 3 clinical trials in advanced and metastatic NSCLC during the past ten years, we have experience overcoming several major challenges of these studies, including considering:
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