Purpose The development of new, targeted, less toxic agents is one of the highest priorities for progress in cancer treatment. Many of these new agents have fewer severe side effects but may require more detailed and subtle testing to assess biologic effects. Recent literature has focused on the cost and intensity of late phase II and III clinical trials, but little has been written about the requirements of current early-phase drug development. We are carrying out a study of our recent experience in the M.D. Anderson Cancer Center Clinical Translational Research Center (CTRC) and the Phase I Program to document the extent of regulatory and other requirements for current developmental cancer clinical trials.
Methods We have developed an access database of virtually all studies, together with a Microsoft Excel spreadsheet matrix for each study that defines the number and extent of the diagnostic and therapeutic requirements for each protocol.
RESULTS We initially analyzed demands for pharmacokinetic (PK) sampling in the first 4 weeks of a protocol as a representative marker for study complexity. Since October 2002, over 250 protocols have been conducted in the CTRC and the Phase I Program; 54.6% were phase I clinical trials. We picked a random sample of 67 trials, which is approximately a quarter of the total. Twenty-seven of these were phase I, 12 phase I/II, 24 later phase II, and four phase III trials. Our analysis demonstrates that in phase I trials, there was a median of 23 (range 1-58) PKs per patient. Phase I/II protocols had a median of 18.5 (range 8-53) PKs per patient. In contrast, later phase II studies had a median of 12 (range 1-51) samples per patient.
Conclusions PK collection in phase I trials is complex and labor intensive and reflects just the tip of the iceberg, with increasingly complicated correlates and monitoring (electrocardiograms, physical examinations, and other tests). We will present an overview of this issue, as analyzed by our database. Successful and accurate phase I clinical trials will require resources and commitment for research infrastructure considerably greater than later-phase studies.
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