Introducing clinical trials into critical pathway

• Published in: The Journal of Japan Society for Health Care Management Vol. 7; no. 4; pp. 504 - 510
• Main Authors: Tomisawa, Taturu, Ichishita, Yumi, Kubo, Mikiko, Hayashi, Junnichiro, Kawano, Fumio, Tajiri, Morihiro, Morimatsu, Yoshitaka, Nakagawa, Yoshihiro
• Format: Journal Article
• Language: Japanese
• Published: Japan Society for Health Care Management 01.03.2007
• Subjects: clinical trial; critical path; pneumonia
• ISSN: 1881-2503; 1884-6807
• DOI: 10.11191/jhm2006.7.504

This study presents the development of a critical pathway for a post-marketing study to explore the availability, security and pharmacokinetics of Doripenem hydrate, a carbapenem antibiotic, administered to patients with pneumonia at a dose of0.25g three times a day. Patients, who met the2criteria for discharge from the hospital, 1.“no fever” and2.“better laboratory data and improvement shown inchest X-ray examinations”, were discharged on the ninth hospital day. Check-ups, observations and drug administration prescribed in the clinical trial protocol to those needed, were adjusted. Subsequently, investigators, nurses and the clinical research coordinator worked together to design this “Plan on Doripenem”. Since the clinical trials were performed parallel to the medical treatment, other than usual inspections and observations were required. However, by introducing the clinical trials into the critical pathway, both, the trials and the treatment, were implemented without problems. Moreover, patients' localization in the clinical course was simplified and in some cases, treatment was promptly be modified. The Kumamoto Medical Center has excelled in its medical care including over50% of its inpatients in the critical pathway. Introducing critical pathways into clinical trials enablesthe center to perform high-quality clinical trials and to provide a standardized medical treatment. Additionally, deviations from clinical trial protocols can be avoided and sponsors of clinical trials have direct access to accurate data acquisitions by browsing raw data easily.