As discussed in PMDA Submission Strategy and CRO Limitations, Part 1, conducting clinical trials and utilizing contract research organization (CRO) services in Japan can be very complex and frustrating due to a number of reasons. This is especially true when a clinical trial of an investigational medical device is to be conducted. In addition to language-related issues, technical and legal issues complicate implementation of medical device trials in Japan.
There are field technical engineers in Japan to facilitate resolution of technical difficulties that are inherent in many clinical trials of medical devices. However, the engineers sometimes need additional specialized training in the particular clinical condition, medical device, or both. There have been cases in which the engineers required additional training which could only be provided at an institution overseas. Obviously, a lengthy and expensive preparation was necessary before a clinical trial could be initiated in this case.
In clinical trials of pharmaceutical drugs which can be simply administered to subjects, management of adherence to specific administration regimen is relatively simple. However, technical aspects such as mastery of proper specialized clinical techniques and procedures by clinicians who actually place the investigational device to a subject make critical differences in the outcome of the trial. For example, mastery and ample experience of a particular technique to correctly use a stent is extremely important in the correct placement of the device and, therefore, proper evaluation of efficacy of the investigational device in subjects. Because of this, ensuring high quality and competency levels among different sites and clinicians involved in a trial is very important in proper implementation of medical device clinical trials.
In Japan, it is uncommon for anyone from a clinical trial team to give advice to the clinician during a procedure. This means the knowledge, experience, and competency level of the clinician who performs the procedure have important influence on the outcome of the procedure. As described in the first part, management of Key Opinion Leader (KOL) networks in Japan is a complicated task in itself. When multiple factors—such as availability of KOLs with proper expertise in a particular field, sites which meet requirements of the client, and paucity of means to remedy any deficiency in technical competency of a clinician who may be able to participate in the trial if such a remedy is available—are combined, the number of appropriate sites and clinicians which can be included in a clinical trial quickly becomes very small.
As described above, successfully conducting medical device clinical trials is a complicated and difficult task. The difficulty significantly increases when such a trial is to be conducted in Japan. In order to ensure successful completion of a trial and approval of the medical device, it is vital to obtain services from CROs which have ample and specific experience in the particular clinical condition targeted in the clinical trial. In addition, accessibility of the CROs to appropriate KOL networks is a major factor to be considered as well.
If you missed Part 1, you can read it here.