Risk Identification Abstractly versus Concretely in Clinical Research in Japan: Randomized and Prospective Research on the Effect of Risk Reduction Activities in a Risk-based Approach

Abstract

Background The risk-based approach (RBA) was first introduced into studies in 2011–2012. As an RBA, it is important to implement risk reduction activities that are proportionate to risk to effectively reduce avoidable quality problems and ensure that they are well adapted to achieving desired goals. However, there is no consistent methodology for identifying and evaluating risks and planning risk reduction activities. Currently, no research has been performed on identifying and evaluating risks and risk reduction activities. We aimed to evaluate risk reduction activities and their effects by using two risk identification and evaluation methods. Methods Among the risk identification and evaluation methods, the one with the least number of categories or questions for identifying risks [risk assessment form (RAF)] and the one with the highest number [risk assessment tool (RAT)] were selected. Each method was used to identify and evaluate risks and plan risk reduction activities to conduct “research on the blood concentration of ponatinib and treatment outcome in patients with chronic phase chronic myelogenous leukemia (CP-CML).” RAF is a method of identifying risk from abstract questions, and RAT is a method of identifying risks from a list of concrete risks. The sites were randomized into two groups to implement planned risk reduction activities using RAF and RAT and to compare the number of errors and protocol deviations per participant visit between the RAF and RAT groups. Results The number of errors per participant visit was lower in the RAF group than in the RAT group, and the number of protocol deviations per participant was lower in the RAF group than in the RAT group. Conclusions Our study reveals that risk reductions can be successfully implemented by using a method to identify and evaluate risks in a small number of abstract categories that are critical to the quality of clinical research.