Pengembangan JEJARING RISET KLINIS · RSUP H. Adam Malik, Medan RSUP Persahabatan, Jakarta RSUP Dr....

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