Leveraging local clinical data to jump-start your Japan business (Part II)

Once a physician has been selected, the physician and manufacturer will need to obtain a hospital director approval. To do this, the manufacturer must submit a formal request to conduct the research. At this stage, the request does not need to contain a great deal of detail. Typically, all that is needed is: an overview of the product, the purpose of the research, the name of the sponsoring physician, information validating the safety of the product, and a description of the product's track record overseas. At this stage, the manufacturer will also need to describe the economics of the arrangement, including any research stipends or costs that will be covered. The need for stipends will depend upon the financial condition of the hospital and the importance of the research. For a financially stable hospital, being the first to use a product can be enough of an incentive to support the research.

Once an approval has been received from the hospital director, the doctor and manufacturer must collaborate on protocol development. In many cases, the manufacturer will simply want to duplicate a study that has already been completed overseas. Although this may be reasonable in some cases, it may be necessary to make adjustments to the protocol to meet local needs and ensure the feasibility of patient recruitment.

Japanese institutions tend to have relatively low patient volumes vs. their foreign counterparts. As a result, it may be necessary to broaden inclusion criteria or reduce exclusion criteria to make a study feasible in Japan. It is not uncommon to lower BMI requirements and / or increase the targeted age range. Japanese patients tend to be older and have lower BMI's than their counterparts in the United States and Europe.

After the protocol has been developed, the manufacturer and sponsoring physician must submit the research for an ethics committee review. As part of this review, the manufacturer and physician must demonstrate that the study is safe and ethical. A typical outline is:

1. Overview of treatment safety
2. Substantiation that the benefits of participation outweigh the potential risks
3. Description of the research methodology
4. Outline of the ethical guidelines for the study, including:
   1. appropriate patient selection criteria
   2. adherence to informed consent
   3. a draft patient application
5. Manufacturer's approval of ethical procedures
6. Manufacturer's approval of research methodology

After the above steps have been completed, the manufacturer and physician should receive a final approval and the research can begin.

In most cases, a well-seasoned physician sponsor will be adept at navigating the approval process. Assuming the physician is supportive and the study does not result in financial hardship for the institution or create risk for the patient, the study should be approved.

To maximize the chance of success, the manufacturer should consider offering support where appropriate. In an informal study, it is not uncommon for the manufacturer to support data collection, analysis, publication and dissemination. Foreign manufacturers can be particularly helpful in creating English language versions of the research and supporting publication and / or creating opportunities for the researcher to present the results of the study at overseas conferences.

For most companies, it will take 3-4 months to obtain an approval for the research. The amount of time required for the study will then vary depending on the ease of patient recruitment, length of treatment, and the number of patients required. Although 3-4 months may seem lengthy, this is often shorter than the amount of time needed to negotiate a partnership agreement or lay the groundwork for entering Japan. If conducted in parallel, an informal study does not increase time to market and will actually increase both the likelihood and magnitude of success.

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