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

Part I: The case for informal clinical studies

September 2012

Companies with 510k-equivalent products breathe a sigh of relief when they learn that local clinical data isn't required to obtain formal regulatory approval for their products in Japan. Once this has been determined, the typical wisdom is to quickly move forward with partnering or regulatory approval. Although it makes perfect sense to avoid a full-blown clinical trial when it isn't required, smaller informal clinical studies can pay significant dividends.

Many products can be imported prior to formal regulatory approval (see: Direct physician imports: a tool for accelerating market entry into Japan, July 2012). As a result, companies can initiate small informal studies with key opinion leaders before product approval and prior to launch. These smaller informal marketing-oriented studies provide a number of benefits, including the:

1. Generation of Japanese patient data to support efficacy claims and address potential skepticism
   Japanese patients, physicians, and potential distribution partners are often skeptical about a product's suitability for Japan. Even relatively small studies (e.g., <50 patients) provide additional comfort that a product that has been successful in treating foreign patients will be similarly effective in Japanese populations.
2. Collection of user feedback regarding product design
   Actual usage in a Japanese clinical setting provides an opportunity to gather real-time feedback regarding a product. This feedback can be invaluable for identifying necessary product changes and/or altering sales and marketing materials to fit the Japanese clinical context.
3. Strengthening of key opinion leader relationships/development of physician advocates
   Project-based collaboration creates an opportunity to strengthen personal relationships with physicians and can be instrumental in developing local advocates that indirectly support longer-term sales and marketing efforts.

For companies that have chosen to partner, the results and relationships created through an informal study can be used to speed partnering discussions. Decision processes are accelerated when the perceived risk of a product is reduced. Physician requests for a device also create a source of external pressure and raise the risk associated with inaction, creating an incentive to move more quickly.

Key opinion leader advocacy can also play a significant role in regulatory and reimbursement negotiations. MHLW officials typically discredit manufacturer claims but are much more likely to heed and respond to direction from clinicians. The majority of MHLW officials do not have medical training. As a result, they place a great deal of importance on physician opinions.

Informal clinical studies are not appropriate for every company and product. Although relatively inexpensive and easy vs. a clinical trial, companies must still dedicate staff time and resources to ensure success. Small companies that lack experience in Japan may fare better by waiting to conduct research in collaboration with a partner. Given the relatively small patient populations for these studies, it is also important that these studies be used only for products that provide relatively consistent outcomes. Products with variable outcomes may be inadvertently fall victim to a small sample size.

Part II: Managing an informal clinical study will provide a step by step overview of how to conduct an informal marketing-oriented study, from physician recruitment to the completion and dissemination of a white paper.

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