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| Preface | Tsutani K,Shimizu N | iii-iv |
| Workshop Program | v | |
| Seminar Program | vi | |
| T.Workshop on Off-label Use of Drug and Evidence 13 March 1998 | 1-113 | |
| 1.Policy of the MHW on this topic | Shiragami M | 3-5 |
| 2.Off-label use and evidence −Background, purpose and method of the MHW project− | Tsutani K | 7-31 |
| 3.Evidence and clinical practice | Nagoh N | 33-52 |
| 4.Evidence and the Cochrane Collaboration | Beppu H | 53-65 |
| 5.From evidence to clinical guideline | Yoshimura M | 67-88 |
| 6.Ethnic difference and evidence | Naitoh C | 89-106 |
| 7.Panel discussion | 107-13 | |
| U.Seminar on Off-label Use of Drug 23 April 1998 | 115-90 | |
| 1.Background of the seminar | Shimizu N | 117-8 |
| 2.Present status and future direction of the off-label use of anti-cancer drugs in Japan | Shimoyama M | 119-28 |
| 3.Problems encountered in conducting MHW-sponsored clinical trials initiated by the research group of intractable diseases | Miyasaka N | 129-38 |
| 4.Background and idea of MHW-sponsored study group on the evidence of off-label use of drugs for intractable and rare diseases | Iwao S | 139-49 |
| 5.Research method of MHW-sponsored study group on the evidence of off-label use of drugs for intractable and rare diseases | Tsutani K | 151 |
| 6.FDA's view on off-label use of drug (6-1Japanese & 6-2English) | Burke L | 153-75 |
| 7.Panel discussion | 177-90 | |
| V.Research report 1997 on the evidence of off-label use of drugs for intractable and rare diseases | Tsutani K | 191-332 |