The 6 th Kitasato-Harvard Symposium Session3:New Challenges Disease Areas. Investigator Initiated Trial (IIT) Future for IIT from the past experience

Transcription

1 The 6 th Kitasato-Harvard Symposium Session3:New Challenges Disease Areas Investigator Initiated Trial (IIT) Future for IIT from the past experience

2 JMACCT Project Clinical Trial Research Project of JMACCT : Conducted in Accordance with the Project of MHLW and the Cross-sectional Grand Design between MHLW and MEXT, which intends to accelerate the Clinical Trial in Japan Launched in October 2003, subsidized by MHLW Based on the Fundamental Principles of JMA Supporting IIT through large scale and/or local networks Improving Clinical Trial Environment in Japan MHLW:Ministry of Health, Labor and welfare MEXT :Ministry of Education, Culture, Sports, Science and Technology 2

3 What is Investigator Initiated Trial Purpose of IIT Improve Medical Care for Patients in Japan by: Developing innovative and/or beneficial drugs for patients, including Orphan Drugs which no company wants to market because they are unprofitable Researching overseas Drugs Which have been evaluated as useful and safe in America and advanced European Countries, but not yet approved in Japan Investigator Responsibilities Designing Protocols Applying to Investigational New Drug Applications (INDs) Reporting of Adverse Drug Reactions New Drug Applications NDAs must be applied by Pharmaceutical Company 3

4 Support for IIT JMACCT establishes a system to carry out High Quality Clinical Trial to support preparing Protocols to support preparing Standard Operating Procedures (SOPs) to support activities related to Reporting of Adverse Drug Reactions to discuss/negotiate with the supplier of the Clinical Trial Drug and Contract Research Organization (CRO) to provide Insurance to urge an understanding of GCP to negotiate with MHLW and PMDA Interpretation of GCP, INDs, PMDA consultation prior to INDs PMDA:Pharmaceuticals and Medical Devices Agency 4

5 Progress of IIT conducted by JMACCT 5

6 Data-Management Department JMACCT establishes Data-Management System to: support Onsite Activities CRC s activity, as a local data manager, is important JMACCT supports Quality Control and Quality Assurance of Clinical Data which are ensured by Investigators support CRF Entry support Data-Management Activities Data-coding, Data-cleaning, Database administration provide consulting Services or Support Helpdesk for Investigator and CRC Currently, JMACCT is undertaking Data- Management on 2 IIT 6

7 Improving Clinical Trial Environment JMACCT facilitate improving the Environment around Clinical Trial organizing Medical institutions into a Nationwide Clinical Trial Network supporting the Medical Institutions that constitute the Network planning Workshops enlighten People about Clinical Trial cooperate with Local Networks publish Reference Books for Investigator 7

8 The Nationwide Clinical Trial Network Enrolled Institutions 1 st October Institutions Hospitals 625 Clinics 461 8

9 Supporting the Medical Institutions Information about Clinical trial Dispatched by JMACCT Newsletter Invitation to participate IIT Invitation to participate Industry- Sponsored Trial Nationwide Network may be used for Industry- Sponsored Trial and Post Marketing Surveillance Efficient Tool for Sponsor to select Institution quickly 2 Clinical Trials Introduced 9

10 Workshops Industry-Government-Academia collaborated Forum for Clinical Trial Promotion 3 rd November participants Promotion of Clinical trial in Japan Clinical Trial : As a step for contributing to progress of medicine Introduce JMACCT s project Symposium for Clinical Trial Promotion 9 th September participants From the IIT Progresses of Drug-Discovery Biotechnology Seeds Medical Affairs and Carrying out Clinical Trial 10

11 Poster We are supporting each other We want to save loving people as possible as we can 11

12 Cooperation with Local Networks Research for Improving Local Network infrastructures Research for Establishment of own Networks by multiple Local Medical Institutions (Local Networks) Local Networks :14 Networks were designated for 2004~ 2005 Purpose Design to share a Common Data Exchange Protocol, aiming at Global Clinical Trial-to-be Establish Patients Panel specified by Disease Central IRB as an sharing System 12

13 14 Local Networks Designated in 2004 Designated in 2005 Ishikawa Pref. Toyama Pref. Hyogo Pref. Hokkaido Univ. Hiroshima Pref. Tokyo Women s Medical Univ. NHO Kanagawa Pref. Ehime Pref. Osaka Pref. Mie Aichi Pref. Nagoya City Shizuoka 13

14 Reference Books for Investigators Clinical Research ABC, an Additional Volume of JMA Journal ( in Preparation) A basic Instruction for Clinical Trial Contents: What s Clinical Research? Ethics of Clinical Research Medical Statistics and How to interpret Clinical Data How to participate in Clinical Research? Clinical Research Protocol Other informative guides to doctors who have eagerness to be investigators 14

15 Future of IIT (1) Conferences held by MHLW Ad-hoc Expert Committee for Un-approved Drugs in Japan Provide the Opportunity to use un-approved Drugs Categorize into IIT/Industry-Sponsored Trial Ensure Implementation of the Clinical trial Ad-hoc Expert Committee for Clinical Trials Essential Improvement of Clinical Trial Infrastructures in order to carry out clinical trials much more promptly Burden Reduction of Staff, especially Investigator, conducting Clinical Trial 15

16 Future of IIT (2) JMACCT will Continue Supporting IIT Continue Improving Clinical Trial surroundings Encourage conducting Industry-Sponsored Clinical Trial at Nationwide Network Cooperate with Local Networks,thereby contributing to progress in the Clinical Trial Infrastructure of Japan 16