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Do we want more cancer patients on clinical trials?

June 3, 2008 Andrew J.Vickers of MSKCC (1) shares his personal perspective from his experience working in a major cancer center in the USA (although other authors have drawn similar conclusions)

[It] is for the reader to judge the degree to which they are applicable to other countries or to non-academic settings.

He observes that the most commonly diagnosed cancer in men is prostate cancer and yet there have been no adequate trials comparing the 2 major treatment approaches-radiotherapy and surgery.
It is obvious to me that we should prefer a single 10,000 patient randomized trial comparing primary treatment for prostate cancer to having 20,000 patients join the sort of early phase trials that typically go nowhere. We need...more patients on the right sorts of trials.
According to one estimate, he notes that about 45% of US-sponsored trials are currently being conducted overseas.
He describes 2 important barriers to greater clinical participation-financial and regulatory.
His references include excerpts in Table 1 (from the Report of the National Cancer Clinical Trials Program Review Group 8/26/97) noting broadly: the practice issues of obtaining informed consent, disqualification of potential enrollees, the need for a common algorithm for protocal development (to minimize the time necessary to obtain and obtain a letter of intent or concept to NCI for consideration and review), reduce data collection (accrue only data pertinent to the study endpoints and patient safety) and the need for a more uniform streamlined process to enroll more patients in trials through info technology
(1) http://www.trialsjournal.com/content/9/1/31 Trials 2008, 9:31

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This page contains a single entry from the blog posted on June 24, 2008 8:54 AM.

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