Experience with Investigator Initiated Trials (IIT) and Medical Engineering Human Resource Development from the Clinical Standpoint

The development of innovative therapeutic equipment should be driven by clinical needs and requires close collaboration between medical doctors and technical experts to integrate their knowledge to attain a common goal. During this process, especially with regard to pharmaceutical agents, the approv...

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Published inTHE JOURNAL OF JAPAN SOCIETY FOR CLINICAL ANESTHESIA Vol. 35; no. 5; pp. 679 - 685
Main Authors ISEKI, Hiroshi, MURAGAKI, Yoshihiro, MARUYAMA, Takashi, IKUTA, Souko, MASAMUNE, Ken, TAMURA, Manabu, YOSHIMITSU, Kitaro, OKAMOTO, Jun, KONISHI, Yoshiyuki, MAEDA, Masanori, CHERNOV, Mikhail F.
Format Journal Article
LanguageJapanese
Published THE JAPAN SOCIETY FOR CLINICAL ANESTHESIA 15.09.2015
Subjects
EBM another EBM (Engineering Based Medicine)
Investigator initiated trials (IIT)
Malignant brain tumor
Medical device development
PDT (photodynamic therapy)
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Summary:The development of innovative therapeutic equipment should be driven by clinical needs and requires close collaboration between medical doctors and technical experts to integrate their knowledge to attain a common goal. During this process, especially with regard to pharmaceutical agents, the approval regulations for the new device, drug, or technology should always be taken into consideration. Such complex objectives require the creation of very specific human resources and the establishment of specialized institutions incorporating experts in various fields.
ISSN:0285-4945
1349-9149
DOI:10.2199/jjsca.35.679