ADVANCING U.S.-JAPAN COLLABORATION IN CANCER CLININAL

UNCLAS SECTION 01 OF 02 TOKYO 002551 DEPT FOR EAP/J AND OES/IHB HHS PASS TO NIH/NCI HHS FOR OGHA DEPT PASS TO AID/GH/HIDN SENSTIVE SIPDIS E.O. 12958: N/A TAGS: TBIO KSTH ECON PGOV SOCI CASC JA SUBJECT: ADVANCING U.S.-JAPAN COLLABORATION IN CANCER CLININAL TRIALS REF: TOKYO 1589 TOKYO 00002551 001.2 OF 002 ¶1. (U) Summary: Dr. Edward Trimble of the National Cancer Institute participated in a series of meetings and programs on October 20 and 21 as part of Embassy Tokyo's ongoing effort to promote increased collaboration between U.S. and Japanese researchers in cancer clinical trials. The activities built on the momentum of a highly successful workshop in July (reftel) by increasing awareness of the issue among Japanese parliamentarians, patient groups, and government officials. End Summary. ¶2. (SBU) In cooperation with the Tokyo American Center (TAC), Econoffs organized a series of programs for Dr. Edward Trimble of the National Cancer Institute designed to raise awareness of the importance of international collaboration in cancer clinical trials. U.S. and Japanese researchers agree increased cooperation in developing drugs to combat cancer would benefit patients in both countries and highlight how strengthened bilateral ties in science, technology, and medicine can improve human lives. Although the number of international clinical trials and drug approvals has increased in Japan in recent years, they are still far fewer than in other advanced countries. Japanese cancer patients do not have access to the same cutting-edge drugs as their counterparts in the U.S. and Europe. Meanwhile, the need for international collaboration in cancer clinical trials has grown stronger with advances in treatment and screening. International collaboration can maximize resources and patients, and lead to more effective therapeutic strategies and drugs. ¶3. (SBU) Dr. Trimble's activities were designed around action items identified during the July workshop. One such item was educating Japanese policymakers about the importance of government support for and facilitation of academic clinical trials, which, unlike trials administered by pharmaceutical companies, can focus on rare types of cancer. To address this action item, TAC and the Embassy organized a "benkyo-kai" (study session) for members of the Japanese Diet. Given the recent election, which ushered in many new, reform-minded parliamentarians from the Democratic Party of Japan (DPJ),the timing was perfect. Nearly a dozen legislators sitting on health committees and their policy staff attended the session, among them Eriko Fukuda, a young female DPJ legislator who gained national prominence as an activist representing hepatitis C victims, and Akira Koike, physician and member of the Communist Party (JCP). (Koike also arranged for an article on the event to be placed in the JCP newspaper Akahata - a first for TAC.) The Ambassador opened the event, lending extra weight to the issue. ¶4. (SBU) The parliamentary "benkyo-kai" was followed by a study session for patient advocates, another group identified in Post's action plan as a key stakeholder in the effort to promote international collaboration. Many Japanese patients, wary of side effects, are ambivalent about clinical trials. Greater advocacy on the part of patient groups could compel policymakers to improve the clinical trial infrastructure in Japan. Approximately ten representatives of patient advocacy groups attended the study session. Dr. Trimble spoke about the National Cancer Institute's programs to educate the U.S. public about the benefits and risks of clinical trials and distributed materials the Institute uses for such public education. ¶5. (SBU) Dr. Trimble also met with several representatives of the Pharmaceuticals and Medical Devices Agency (PMDA),the main Japanese drug regulatory body. PMDA staff expressed support for the concept of international collaboration in licensing trials, and told Dr. Trimble they encourage Japanese academic investigators to participate in global trials. During the discussion, Dr. Trimble was able to dispel some myths that PMDA staff had about the U.S. model for cancer clinical trials, such as the belief that control groups in U.S. cancer trials are given only a placebo. ¶6. (SBU) Additionally, Dr. Trimble's program included meetings with a pharmaceutical company to learn about industry's role in improving the current state of the clinical trials infrastructure in Japan, called on a member of the Prime Minister's Council on Science and Technology Policy (CSTP),and held a roundtable discussion with Japanese public health experts. His activities in Tokyo were followed by a keynote address at a major oncology conference in TOKYO 00002551 002.2 OF 002 Yokohama on the subject of global clinical trials. ¶7. (SBU) Dr. Trimble's follow-up visit was highly successful in terms of accomplishing several goals in our action plan, in expanding our range of contacts on this issue, in raising awareness of the issue among several key groups and individuals, and in better understanding the opportunities and challenges in the endeavor to promote greater U.S.-Japan collaboration in clinical trials. A series of related events held between the July 2009 workshop (reftel) and Dr. Trimble's October visit, including an oncology career development seminar sponsored by the Academy of Cancer Experts and TAC, have also highlighted the issue. The National Cancer Institute and Embassy Tokyo have identified several areas for further action, including a proposed U.S. study tour for Japanese patient advocates under the auspices of the International Visitor Leadership Program (IVLP). At a time when the media is focused on the security dimension of the U.S.-Japan relationship, we believe that programs like this can highlight other aspects of the of U.S.-Japan ties such as the kind of scientific collaboration that carries the promise of improving lives. ROOS