CURRENT SITUATIONS AND ISSUES FOR PHASE I CLINICAL TRIALS SPONSORED BY PHARMACEUTICAL COMPANIES CONDUCTED AT REGIONAL CANCER CENTER HOSPITALS IN JAPAN

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Abstract

In phase I clinical trial sponsored by a pharmaceutical company, the following factors, (i) rapid patient enrollments, (ii) accurate evaluation for safety and efficacy, and (iii) pharmacokinetics/pharmacodynamics (PK/PD) data accumulation are always required in a short period for drug development in Japan. This establishes the strict standard for phase I site selection by a pharmaceutical company to prevent ‘clinical development delay’ and ‘inefficient clinical trial budget consumption’.

The main issues for Japanese phase I clinical trials faced by regional cancer center hospitals are (a) lack of investigators well experienced phase I trials, (b) lack of clinical research coordinators (CRCs) who can handle complicated procedures in a phase I trial, especially on a safety handling procedure, (c) lack of study staffs who can manage clinical sample preparation for a PK/PD analysis, and (d) absence of ophthalmologists and cardiologists who can evaluate atypical toxic effects.

In Shikoku Cancer Center (SCC), all of these issues have been resolved with enormous efforts according to the mission for regional and national cancer hospitals. Seventeen phase I and eight phase I/II trials have been carried out in SCC for recent 2 years. Almost all of eight CRCs can handle phase I trials through their cumulative experiences. They have been continuously educated by clinical trial educational seminars/sessions, especially for early phase trials. SCC has one clinical technician who can manage PK/PD blood sample preparations who have great contributions for trial performances now. Furthermore, a phase I-specialized clinical research ward has been established since July 2011.

Japanese regional cancer center hospitals trying to overcome these issues need continuous effort with enormous support from site departments and study staffs with full understanding of the concept and value of phase I trials.

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