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Although the number of new compounds in development has increased over time, the high cost of clinical trials remains a challenge because of a number of factors, including ever-increasing time and financial pressures on clinician-investigators, excessively risk-averse interpretations of regional and federal regulations, the increased complexity of clinical trial protocols, and the high cost of on-site clinical data-quality monitoring (often including 100 percent source document verificationthe practice of comparing each data point entered in a clinical trial with information from the primary health records of a trial participant)

D., Ramachandran, A

New York: Plenum Press.155193 6

Annals of Oncology 31 (suppl_4): S1142S1215

A few key takeaways Some important things to consider in light of this letter that has import into compounding and drug production in general: This letter documents systemic failure, not isolated incidents

HUBERMAN: Thank you