2020 年 51 巻 4 号 p. 199-203
The importance of incorporating patient insight in drug development is increasingly becoming recognized, empowered by the heightened awareness of patient-centric medical care. The purpose of this research is to identify specific processes in clinical trials that are not patient-centric, and to discuss how pharmaceutical companies and medical staff could cooperate, in order to develop patient-centric strategies in drug development.
In this research, we interviewed investigators, study coordinators and other medical staff involved in our clinical trials from April 2018 to October 2018.
Almost half of the medical staff answered that pharmaceutical companies should work on the development of Patient-Friendly Protocols (38.8％). The development of Patient-Friendly Informed Consent Documents (24.5％), the disclosure of clinical trial information (28.8％) and the disclosure of clinical trial results (34.6％) were also emphasized by medical staff as areas of improvement.
Interview results suggested that pharmaceutical companies should not only include patients, but also clinical trial staff in the process of incorporating patient preferences in order to overcome the lack of experience and knowledge of patients. Raising further awareness of the benefits of disclosing clinical trial information to patients is a challenge Japanese pharmaceutical companies, investigative sites and regulatory authorities should work on together.
The commitment of pharmaceutical companies and the cooperation of investigative sites are necessary to push forward patient-centric drug development in Japan.
