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Aim
of Establishing the Department |
The Department of Pharmacoepidemiology was newly established in 2000
as the first official department for application and education in
this field in Japan. There has been a great social demand for using
appropriate drugs, practicing standard treatments and preventing adverse
drug reactions. Therefore the mission of the department is to accomplish
those social demands.
Pharmacoepidemiology is a natural crossing of scientific paths, including
clinical epidemiology and clinical pharmacology. Pharmacoepidemiology
can be defined as disease-drug informatics which carries out application
of epidemiologic reasoning, methods, and knowledges to the study of
the uses and effects (beneficial and adverse) of drugs in human populations
including clinical trials to@improve outcomes of diseases.
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Faculty |
| Professor:
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Masanori
Fukushima, M.D. Ph.D. (Kyoto Univ.) |
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Specialty:
1. Medical oncology; 2. Design and management of clinical trial |
| Associate
Professor: |
Shigeyuki
Matsui, PhD (Tokyo University of Science) |
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Specialty:
1. Biostatistics 2. Design and analysis of clinical trial |
Technical
Assistant: Kana Nishisaka
Technical Assistant: Takako Nomura
Graduate Student: Harue Tada, MPH, RN
Graduate Student: Master course student: Naoko Maeda, Pharmacist
Graduate Student: Master course student: Rie Sakai, MD
Graduate Student: Master course student: Shinzo Hiroi, Pharmacist
Graduate Student: Master course student: Tomomi Makimura, BSN, RN
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Teaching
Activities |
This section is responsible for instruction in pharmacoepidemiology
and design and analysis of clinical trials to graduate students.
Pharmacoepidemiology
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Content: |
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Understanding
purpose, method and role of Pharmacoepidemiology
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Goal:
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Picking
up the problem through development to dispensing of drugs and
planning the approach to solve it.
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Educational
method: |
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Systematic
review of general pharmacoepidemiological methodology
Group study, interactive discussion between lecturers and students
Debate on special medical topic
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Withdrawal
of oral antihyperglycemic agent, pioglitazon (in 2000) |
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Warning
of the cancer risk of simvastatin (in 2001) |
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Textbook: |
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Hartzema,
A.C. et al ed. Pharmacoepidemiology: An Introduction 3rd ed.,
Harvey Whitney. 1998. |
Design and analysis in clinical trials
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Content: |
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Design
and analysis of clinical trials. Development of protocol. Data
management. Critical evaluation of clinical trial papers.
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Goal: |
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Being
able to write a protocol of clinical studies and to perform
statistical analysis.
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Educational
method: |
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Systematic
review of general methodology for clinical trials.
Special lecture on recent topics relating to clinical trials.
Tour of CRO(Contracted Research Organization), pharmaceutical
industry and new drug trial operation office in university hospital
Practice of SAS(Statistical Analysis System) using note PC
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Presentation: |
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Critical
appraisal for clinical trial articles
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Textbook: |
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Spilker
B., Ed. Guide to Clinical Trials, Raven Press 1991 |
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Research
Activities |
The current research activities are mainly focused on clinical application
of pharmacoepidemiological methodologies.
The general research subjects undertaken include:
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1.
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Developing
a new methodology for pharmacoepidemiology and its application. |
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2.
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Risk
management for adverse drug effect after marketing. |
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3.
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Planning
a epidemiologic study for monitoring adverse events on a new
drug. |
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4.
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Designing
clinical trials for new treatments and analyzing their results. |
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5.
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Biostatistical
consultation for biological experiments and clinical researches. |
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6.
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Developing
a new biostatistical methodology. |
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7.
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Developing
a new IT(Information Technology) to support clinical trials. |
The individual research subjects:
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1.
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Projection
of the number of patients with Creutzfeldt-Jakob disease from
cadaveric dura transplantation in Japan |
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2.
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A
Cost-Effectiveness and safety evaluation of new combination
chemotherapy in non-small cell lung cancer patients |
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3.
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Influenza-associated
encephalopathy in Japan. Statistical analysis for possible association
with NSAIDs |
This department also contributed on the society to warn the signal
of the drug disaster and to improve medically important regulatory
decision-making.
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1.
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Improvement
for the description of the side effect of oral antihyperglycemic
agent, pioglitazon in the package insert |
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2.
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Prohibition
of NSAIDs with children for antipyretic use |
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3.
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Proposal
for a countermeasure of BSE(Bovine Spongiform Encephalopathy)
and vCJD (variant Creutzfeldt-Jakob disease) in Japan |
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Publications |
| 1.
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Matsuura,
H., Schuller, D.E., Fukushima, M. and Coltman, C.A. Summary
of the proceedings of the United States and Japan Head and Neck
Cancer Clinical Trials
Summit, 19-20 September 1997, Kyoto, Japan. J Cancer Res Clin
Oncol 125:433-438, 1999. |
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Hayakawa,
T., Naruse, S., Kitagawa, M., Ishiguro, H., Kondo, T., Kurimoto,
K.,Fukushima, M., Takayama, T., Horiguchi, Y., Kuno, N., Noda,
A. and Furukawa, T. A prospective multicenter trial evaluating
diagnostic validity of multivariate analysis and individual
serum marker in differential diagnosis of pancreatic cancer
from benign pancreatic diseases. Int. J Pancreatology 25(1):23-29,
1999. |
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Sasaki,
H., Niimi, S., Akiyama, M., Tanaka, T., Hazato, A., Kurozumi,
S., Fukushima, S. and Fukushima, M. Antitumor activity of 13,14-dihydro-15-deoxy-’7-PGA1-methyl
ester integrated into lipid microspheres against human ovarian
carcinoma cells resistant to cisplatin. Cancer Res 59:3919-3922,
1999. |
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Leigh,
B.R., Gandara, D.R., Crowley, J.J., Furuse, K., Livingston,
R.B., Fukushima, M. and Coltman, C.A. Summary of the proceedings
of the United States-Japan Lung Cancer Clinical Trials Summit:
San Francisco, Califormia, 20-22 November, 1998. Lung Cancer
24:181-191, 1999. |
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Fukushima,
S., Kishimoto, S., Takeuchi, Y., Fukushima, M. Preparation and
evaluation of o/w type emulsions containing antitumor prostaglandin.
Advanced Drug Delivery Reviews. 2000, 45:65-75. |
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Fukushima,
S., Takeuchi, Y., Kishimoto, S., Yamashita, S., Uetsuki, K.,
Shirakawa, S., Sawada, J., Kojima, M., Suzuki, M., Futsuta,
K., Noyori, R., Sasaki, H., Kikuchi, Y., Kita, T., Yamori, Y.,
Hazato, A., Kurozumi, S., Fukushima, M. Antitumor Activity,
Optimum Administration Method and Pharmakinetics of 13,14-Dihydro-15-deoxy-’V-prostaglandinA1
methy1 ester (TEI-9826) Intergrated in Lipid Microspheres (Lipo
TEI-9826). Anti-Cancer Drugs. 2001,12: 221-234. |
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Fukushima,
M., Kataoka, T., Hamada, C., Matsumoto, M. Evidence of qi-going
energy and its biological effect on the enhancement of the phagocytic
activity of human polymorphonuclear leukocytes. American Journal
of Chinease Medicine. , 29(1): 1-16,2001. |
| 8.
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Mohri,
K., Fukushima, M., Matsumoto, M. Gradual decrease of electric
resistivity in water triggered by milli-gauss low frequency
plused magnetic field. Transactions of Magnetics Society of
Japan. , 1(1),22-26; 2001. |
| 9.
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Toshimitsu
Ishida and Chikuma Hamada et al. New DNA polymorphism of human
MMH/OGG1 gene: prevalence of one polymorphism among lung-adenocarcinoma
patients in Japanese. International Journal of Cancer,80,18-21,1999. |
| 10.
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Hiroyuki
Morita,Hiroki Kurihara,Takao Sugiyama Chikuma Hamada,Yukiko
Kurihara,Takayuki Shindo,Yoshio Oh-hashi and Yoshio Yazaki.
Polymorphism of the methionine synthase gene association with
homocysteine metabolism and late-onset vascular diseases in
the Japanese population. Arteriosclerosis,Thrombosis and Vascular
Biology,19,298-302, 1999. |
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Ikuo
Nagashima,Teruaki Oka,Chikuma Hamada,Katsutoshi Naruse,Takuya
Osada and Tetsuichiro Muto. Histopathological prognostic factors
influencing long-term prognosis after surgical resection for
hepatic metastases from colorectal cancer. The American Journal
of Gastroenterology,94-3,739-743, 1999. |
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Junichi
Sakamoto,Chikuma Hamada,Susumu Kodaira,Hiroaki Nakasato and
Yasuo Ohashi. Adjuvant therapy with oral fluoropyrimidines as
main chemotherapeutic agents after curative resection for colorectal
cancer: individual patient data eta-analysis of randomized
trials. Japanese Journal of Clinical Oncology, 29-2,78-86, 1999. |
| 13.
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Manae
Kurokawa and Chikuma Hamada et al. Frequency of clonally expanded
T cells evaluated by PCR from a single cell. Journal of Immunological
Methods,224, 203-208, 1999. |
| 14.
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Yasuyuki
Suzuki,Shiroaki Shirato,Misato Adachi and Chikuma Hamada. Risk
factors for the progression of treated primary open-angle glaucoma:
a mulitvariate life-table analysis. GraefeΥs Archive for Clinical
and Experimental Ophthalmology,237,463-467, 1999. |
| 15.
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Yasushi
Imai,Hiroyuki Morita,Hiroki Kurihara,Takao Sugiyama,Norihiko
Kato, Aya Evihara,Chikuma Hamada,Yukiko Kurihara,Takayuki Shindo,
Yoshio Oh-hashi and Yoshio Yazaki. Evidence for association
between paraoxonase gene polymorphism and atherosclerotic diseases.
Atherosclerosis, 149,435-442, 2000. |
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Kiyoshi
Kubota, Eri Kawabe, Shiro Hinotsu, Chukuma Hamada, Yasuo Ohashi
and Kiyoshi Kubota. Pilot study of prescription-event monitoring
in Japan comparing troglitazone with alternative oral hyperglycemics.
European Journal Clinical Pharmacology,56,831-838, 2001. |
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Invited
lectures |
| 1.
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Masanori
Fukushima, A Sino-Japan Seminar on Pharmaceutical Development
Cancer Therapy, New stage toward Multinational Trial. 2000.7
China. |
| 2.
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Masanori
Fukushima, M. International Biotechnology Convention& Exhibition.
Epidemiology and Trends in Drug Uses Under the National Health
Insurance
System with Controlled Price Setting in Japan.2001,6 USA. |
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Presentation
at International Meeting |
| 1.
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Chikuma
Hamada, Junichi Sakamoto, Susumu Kodaira, Hiroaki Nakasato and
Yasuo Ohashi. DIA 6th Annual Biostatistics Meeting in Tokyo.
Meta-analysis of randomized trials for colorectal cancer with
oral fluoropyrimidines. 2000,8 Japan. |
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Naoko
Maeda, Harue Tada, Tetsuji Sadaike, Chikuma Hamada and Masanori
Fukushima: Influenza-associated encephalopathy in Japan-Subtype
of Reye's syndrome? Possible association with NSAIDs. 17th international
conference on pharmacoepidemiology. 2001,8 Canada |
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Future
Prospects |
Today, developments and approvals for new drugs are strikingly accelerated.
In accelerated drug approval program, surrogate endpoints are used
to evaluate efficacy. Being ahead of these new medical trends for
accelerated drug approval, the systematic PMS is the most important
challenge. Therefore, collaborative surveillance by pharmaceutical
companies, academia, and regulatory agency is indispensable to prevent
serious adverse reactions.
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Contact |
info@kupe.org |
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