pengembangan jejaring riset klinis · rsup h. adam malik, medan rsup persahabatan, jakarta rsup dr....
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PengembanganJEJARING RISET KLINIS
Puslitbang Sumber Daya dan Pelayanan Kesehatan
Penelitian Kesehatan
Pre-clinical Research
Clinical Research (Penelitian
Klinis)
Public Health Research
Observational Research
Interventional Research
Clinical Trial (Uji Klinik)
Cohort
Case Control
Cross Sectional
Case Report/ Series
Medical Device
Drug/Vaccine
JEJARING RISET KLINIS INDONESIA
Tujuan Jejaring RisetMengatasi tantangan dalam melakukan riset, seperti:
• Persetujuan etik• Birokrasi dari izin penelitian• Penerapan Perjanjian Pengalihan Material (MTA) dan Hak Kekayaan
Intelektual (HKI)• Menyediakan forum untuk berbagi ide, keahlian dan infrastruktur• Mampu mencapai apa yang tidak bisa dilakukan oleh satu institusi
sendiri• Riset besar• Riset epidemiologi• Riset penyakit langka
Anggota Jejaring Riset2013 : 8 RS2019 : 19 RS
RS Jejaring: RSUPN Dr. Cipto Mangunkusumo, Jakarta RSU Kab Tangerang, Tangerang RSUD Dr. Soetomo SurabayaRSUD dr. Zainoel Abidin, Banda Aceh RSPI Sulianto Saroso, Jakarta RSUP Hasan Sadikin Bandung RSUP Sanglah DenpasarRSUP H. Adam Malik, Medan RSUP Persahabatan, Jakarta RSUP Dr. Kariadi Semarang RSUP Wahidin Sudirohusodo MakassarRS Budi Kemuliaan, Batam RS St. Carolus, Jakarta RSUP Dr. Sardjito Jogja RSUD dr. Soedarso, PontianakRSUD Ansari Saleh, Banjarmasin RSUD Abdul Wahab Sjahranie, Samarinda RSUD Abepura, Jayapura RSUD Dr. TC Hillers, Maumere
Mitra Internasional
• US-NIH• US-CDC• USAID/NAS• Colombia University• Wellcome Trust• Kirby Institute
Peningkatan Kapasitas Peneliti
• Good Clinical Practice (GCP) atau Cara Uji Klinik yang Baik (CUKB)
• Good Clinical Laboratory Practice (GLCP) Training
• Protocol Development and Navigator Training• The Methods in Epidemiologic, Clinical and
Operations Research • Bio-repository Training• IRB Training• Open Clinica Training• Manuscript Writing Workshop
Protocol Writing Workshop
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OpenClinica training
Investasi Riset Klinis
• Clinical Research unit di RS Jejaring• Sekretariat di Puslitbang SD & Yankes• Specimen repository• Reference laboratory
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CRU RS Adam Malik
Clinical Research Unit Dedicated room for researches Internet network Laptop, printer, scanner, barcode
scanner Locked cabinet Minus 80°C freezer Site team according to study
(GCP training) Dedicated Research Assistant
Data Manajemen CenterData managerIT specialistsStatisticiansData entry personsData analysis & statistical softwareElectronic Data CaptureData Server & Back up server
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Sequencing dan Bioinformatika
Center
Pathogens Bacteria, virus, parasite, fungus
MethodsCulture
VirusSerology Molecular Sequencing
Equipment
BSC Incubator Autoclave Waterbath Inverted
microscope
ELISA Reader & washer
Fluorescence microscope
PCR conventional
Real Time PCR
New Generation Sequencing (NGS) Machine
Reference Lab Capacities
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Reference Lab TestsPathogen Diagnostic tests (Hospital) Diagnostic tests (Reference Lab)
Dengue RDT IgM/IgG, NS1 rRT-PCR , Nested RT-PCRELISA IgM/IgG (Focus®)
Salmonella Widal , Tubex TF ®, Typhidot, Blood culture
Conventional Nested PCR (Hatta et.al 2007 ELISA IgM/IgG (My Biosource®)
Rickettsia Not available rRT-PCR (Rickettsia sp, O. tsutsugamushii, R. typhi , R. felis)Murine typhus IgM and IgG (Fuller®)Spotted fever group typhus IgM and IgG (Fuller®)Scrub typhus IgM and IgG (inBios®)IFA for Spotted fever
Chikungunya RDT IgM/IgG (rarely available) rRT-PCRELISA IgM/IgG (Euroimmune®)
Leptospira MAT (only in Semarang) rRT-PCRELISA IgM (Focus®) /IgG (Sirion®)
Measles Not available RT-PCRELISA IgM/IgG
Reference Lab TestsPathogen Diagnostic tests (Hospital) Diagnostic tests (Reference Lab)
Influenza Not available RT-PCRELISA IgM/IgG (Sirion®)RDT Quickvue Ag Influenza A & B
RSV Not available rRT-PCR (RSV-A & RSV-B)ELISA IgM/IgG (Sirion®)
HHV-6 Not available quantified rRT-PCR
Hanta virus Not available rRT-PCRELISA IgM/IgG (PanBio®)
HIV Rapid Serology TestIn a few hospitals: 4th Generation ELISA
Rapid Serology Tests 4th Generation ELISA, RT-PCR
Zika virus Not available rRT-PCRELISA IgM/IgG (My Biosource®)
Flavivirus Not available RT-PCRBlood Stream Infection
Not available 16 sRNA PCRPCR for general pathogens (S pneumonia, K pneumonia, E coli)
SOP Penelitian Klinis
27 guideline
79 SOP
80 form
81 template
43 log
18 check list
Rencana Tindak Lanjut
• Pembentukan focal point riset klinis di Badan Litbangkes (Pusat Sumber Daya dan Pelayanan Kesehatan)
• Peningkatan sinergi antar regulator (Balitbang BPOM, Ditjen Yankes, DitjenFarmalkes) dengan pihak penyelenggara riset klinis (RS, perguruan tinggi, CRO, Perusahaan Farmasi, Peneliti)
• Membangun pengorganisasian sistem jejaring riset klinis • Pemantapan dan sosialisasi sistem web-site Registri Penelitian Klinis • Advokasi penelitian oleh Tim MTA terkait Kerjasama Penelitian (pembuatan
MOU, pembuatan kontrak, pengembangan ide penelitian)• Mendorong uji klinis dari inovasi anak bangsa (temuan peneliti Indonesia)
Penelitian Kesehatan
Pre-clinical Research
Clinical Research (Penelitian
Klinis)
Public Health Research
Observational Research
Interventional Research
Clinical Trial (Uji Klinik)
Cohort
Case Control
Cross Sectional
Case Report/ Series
Medical Device
Drug/Vaccine
KlasifikasiUji Klinis
TERIMA KASIH
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