P220: Decentralized Clinical Trials Platform Construction for Implementation in Ultra-Rare Cancer Clinical Trial in Japan
Poster Presenter
Hisahiro Ito
Head of Project Management Office
National Cancer Center Japan Japan
Objectives
In Japan, clinical trials for rare cancers are generally conducted only in large cities, so Decentralized Clinical Trial (DCT) will bring great benefits for access to clinical trials for patients living in remote areas. We construct DCT platform in clinical trials for rare cancers.
Method
The first target clinical trial was an investigator-initiated clinical trials of oral drug for ultra rare cancer. Several DCT elements have been combined to construct DCT platform and we also created the DCT operation procedures and manuals to be implemented in the clinical trials.
Results
This DCT model is designed to enable patients to participate in clinical trials remotely, without the need to visit the trial site, by outsourcing examinations to medical institutions near the patient's home.
To construct DCT platform, we first organized the DCT task force within our National Cancer Center Hospital (NCCH). The team mainly consisted of project managers of ARO(Academic Research Organization)unit, with additional members from clinical research coordinators, pharmacists, clinical research associates and so on. DCT task force first selected applicable DCT element for the trial, developed procedures related to each element, and coordinated various tasks made by multiple stakeholders.
The following DCT elements were incorporated into our DCT platform in the investigator-initiated trial.
a) Remote patient registration system: Registration to Electronic medical record, Payment of medical expenses and Coordination of visit schedule.
b) eConsent system: Built on a system already available in Japan (MIROHA?) , Conduct in the presence of the attending physician at the satellite site (“D to P with D”).
c) Telemedicine system(Same as above)
d) Remote data transfer system: At the beginning, operated by Fax and postal mail. Now a cloud-based data sharing system is under development that complies with Japan’s strict regulations.
e) Direct Drug Delivery procedure: Delivery of investigational drugs directly from NCCH to the patient's home by a courier service.
DCT operation procedures and manuals were created. The operational tasks of DCT were broken down into approximately 250 items, and each task was assigned a role & responsibility to each stakeholder. In establishing DCT platform and finalizing procedures, we followed GCP, the guidance and ordinances related to each DCT elements and consulted with PMDA on any unclear points.
Conclusion
This time, we have constructed a DCT platform in clinical trials for ultra-rare cancers. It is hoped that the implementation of the DCT platform will increase the opportunities for patients living in remote areas to participate in clinical trials.
