4 top tips on investigator site management for clinical trials in Japan
If you are planning a clinical trial program involving Japanese sites, here are some basic considerations:
- The exact date and time of a site shipment needs to be determined prior to dispatch. Unlike the global standard where shipping to a clinical site means processing a shipment request and dispatching on the next most convenient courier, in Japan there is traditional etiquette to identify specific dates and times. In the same way, if you are trying to make an appointment with a potential client, it is expected that the visitor (in this case the site monitor) contact the site personnel first to check their availability to receive the clinical material. The handover process is still a very personal experience and great care must be taken when interacting with site staff. It was only in 2008 that the law changed to allow 3rd party vendors to directly distribute clinical material to sites. Until then, site shipments were always hand-carried to the site by a representative of the pharmaceutical company. The following particulars need to be negotiated with Japanese sites when delivering:
- Delivery date and exact time (not a minute early or a minute late)
- Name of person and back-up person who will receive the clinical material
- Any other site-specific requirements, like which car park to use and which entrance to use
- Courier drivers are generally required to handle data loggers at the site, as site staff generally do not do this. Japanese site staff generally do not handle data logger downloads or “fit for use” evaluations. For this reason, the next best option is to combine this service offering with a courier company. The courier driver will be required to open the shipper box and stop the data logger at the time of hand-over to the site personnel. They will be required to download the data and forward this back to either the pharmaceutical company, CRO or CMO.Because of this – particularly for studies where clinical supply is being controlled by a company located overseas – the turn-around time for a “fit for use” evaluation can take up to 48 hours at times.
- Due to space constraints at Japanese sites, often only very minimal quantities can be stored at sites. Storage availability in Japanese hospitals can be extremely limited. It is imperative that a good clinical supplies strategy is put in place prior to starting a study. Consider:
- Overall size of patient kits to be stored and administered at site
- Enrollment speed
- Maximum storage space available to a particular protocol at each site
- Temperature sensitivity
- Japanese sites do not handle the destruction of used/unused clinical material and returned clinical materials are often stored for long periods of time. The capability of destroying used/unused clinical material differs from country to country. In Japan, as it is in other countries, the In-Country-Caretaker is responsible for handling the reconciliation and return of used/unused clinical material to a storage facility. In some specific cases, like the destruction of needles or materials that have come into direct contact with a patient, clinical sites will perform the disposal of these, but for the most part the clinical material used in the study must be reconciled at the site and returned to a storage facility. One area that is considerably different from international standards is the long-term storage of returned (used/unused) material. While long-term storage is not a requirement by law, on occasion during the PMDA review process, auditors may request to see samples of the returned material and it is for this reason the majority of pharmaceutical companies in Japan continue to store until the submission of the NDA. It is important to be aware of this custom and make a decision on whether you will employ it or not. It is also important to budget for this cost. It is not uncommon for companies to store returned product for up to seven years.