Predictability of the implementation rate of clinical trial at the time of the contract

Abstract

The improvement of implementation rate is an important issue when conducting clinical trials. We, therefore, have investigated the factors which influenced the implementation rate using the protocol data of the clinical trials in the past. Multi-regression analyses were performed using 38 clinical trials of the outpatient subjects which were conducted during 5 years from 2003 until 2007. As a result, 3 parameters (number of inclusion criteria, study duration (day), number of laboratory tests) influenced the implementation rate, but contents of laboratory tests did not. By substituting the data of these 3 factors for the regression equation, the implementation rate of the concerned clinical trial would be estimated at the time of the contract, resulting in the qualitative improvement of the clinical trial management.