Challenge #1:
Proper site selection is always critical to study success, and is very often challenging. According to information from Pharma Intelligence Informa, two-thirds of all clinical trial sites are unable to meet enrollment goals, with half of all sites recruiting one or zero patients.
In this study, the challenge of selecting the right sites was amplified, as there was a limited number of viable investigative sites due to equipment scarcity and timeline constraints.
Challenge #2:
As both sites began enrollment patients, a second major, unexpected challenge arose: COVID-19. The study was paused as closures occurred due to the pandemic.
Across the industry, COVID-19 caused an unprecedented challenge for investigators, sponsors, and CROs. According to a study by Medidata technology and solutions, the ability to conduct clinical trials during the pandemic had affected 69% of respondents. Over half of all respondents mentioned concerns with subject enrollment and recruitment. New studies were especially hit hard, with 78% of respondents reporting the pandemic had affected the initiation of new trials.
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