The Undeniable Truth
Everyone is aware that patient enrollment is an issue. In a recent report from Tufts Center for the Study of Drug Development on 150 global trials, it was discovered that 9 out of 10 studies eventually achieved enrollment goals, but that it can take up to double the original enrollment timeframe to do so.
The report also found that:
• 11% of sites failed to enroll a single patient
• 37% under-enrolled
• 39% met enrollment targets
• 13% exceeded their targets
You cannot deny the existence of significant enrollment concerns. As an industry, we need to do a better job at preparing sites up front to meet their objectives in order to keep studies on track and deliver potentially life-saving drugs to patients.
Enrollment Delays around the World
In almost every region around the world, it is normal to see enrollment delays of at least a month or more. Despite dedicated efforts by countless agencies and regulations across the globe, there is no poster child for solving the enrollment plague. With the recent globalization of clinical research, enrollment challenges are no longer contained to a few countries. This is a global issue.
The Bottom Line
From the Tufts report, we can conclude that nearly 50% of sites do not achieve their enrollment targets. This fact is startling, considering the record-high cost of executing a clinical trial today. In addition to the fixed costs associated with reactionary revival strategies, failure of sites to meet enrollment targets results in immeasurable opportunity costs as well.
Depending on the type of compound being developed, every day lost can mean tens of thousands up to a million dollars in additional expenses and lost revenue.
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