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European Pharmaceutical Contractor
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Patient recruitment and enrolment are destined to become more challenging as the number of clinical studies grows. There are presently an estimated 50,000 to 60,000 ongoing clinical trials in the US alone (1), and there is every reason to expect this figure to increase based on the rise in R&D expenditures; the number of compounds in the pipeline; the growing number of patients per new drug application (NDA); and the more complex and global nature of trials. Growth is likely to be accompanied by a rise in directly competitive clinical trials, with many seeking access to the same investigators. In addition, there are bound to be more studies aimed at testing new compounds in special populations, which will yield a marketing advantage to the innovator if the studies prove successful.
The traditional patient recruitment model has centred around sponsors' reliance on proven investigators who promise to recruit the agreed upon number of patients from their own resources. In the past, this approach was generally successful as there were far fewer trials than there are presently. Today, a sought-after investigator is likely to have already used an in-house patient database to enrol several ongoing competitive trials, so that investigator may have exhausted his or her supply of potentially qualified patients for new trials. This reality is reflected in the fact that 78 per cent of today's clinical trials fail to meet patient enrolment deadlines (2).
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
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