Conducting Clinical Trials in Asia: Global Engage.May.2013

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Medpace Director of Clinical Operations Mainfong Ang, presented a current view of best practices in Asia at the Global Engage conference, May 2013

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  • China:For overseas SAEs or SUSARs occurred out of China, it will depends on EC’s requirement, normally monthly/ 3-monthly/ biannually. Korea: For localSAEs, the timeline will be 24 hours of awareness for some hospitals where online submission is available (e.g. AMC and Inha university hospital).
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  • Protocol writing: hepatocellular carcinoma by the American Association for the Study of Liver Diseases Vs. European Association for the Study of the Liver Vs. the Asia-Pacific Association for the Study of the Liver.
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  • Efficient feasibility/ site evaluation – during on-site evaluation
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  • Conducting Clinical Trials in Asia: Global Engage.May.2013

    1. 1. FOCUSED. TRUSTED. GLOBAL.Opportunities and Challenges of ManagingClinical Trials in AsiaMainfong AngDirector, Clinical Operations
    2. 2. FOCUSED. TRUSTED. GLOBAL.1Agendao Introductiono Operational and Logistical aspects of runningtrials in Asiao Challenges and advantages of various Asiancountrieso Best practices to get most from the siteso Special consideration of oncology programs
    3. 3. FOCUSED. TRUSTED. GLOBAL.2Demographywww.clinicaltrial.gov (as of 23Apr2013)
    4. 4. FOCUSED. TRUSTED. GLOBAL.3FDA inspection (1/Oct/2008 – 30/Sep/2012)o Conducted by Centre for Drug Evaluation andResearch (for bio-monitoring)Country Total NAI VAI OAI %NAIUS 1078 583 430 65 54UK 19 7 12 0 37Canada 27 16 11 059China 11 6 5 0 54KR 8 4 4 0 50TW 3 2 1 0 66*NAI (no action indicated); VAI (voluntary action indicated); OAI (official action indicated)Resource: http://www.fda.gov/iceci/enforcementactions/ucm222557.htm
    5. 5. FOCUSED. TRUSTED. GLOBAL.4Number of Registered Clinical Trialso Contribution fromAsia value inClinical trial= 14.36 %Region Name Number of StudiesWorld 143954Africa 3245Central America 1836East Asia (Japan) 12521 (2677)Europe 39018Middle East 5862North America 75001North Asia 2677Pacifica 3942South America 4850South Asia 2573Southeast Asia 2903www.clinicaltrial.gov (as of 23Apr2013)
    6. 6. FOCUSED. TRUSTED. GLOBAL.5Key Milestone for Clinical Trials – Start-upo Comparison of start-up timelineCountry IRB/RECsubmissionRegulatorysubmissionTotaldurationParadigmHong Kong 4 – 8 weeks 12 – 16weeks16 – 24WeeksParallelChina 4 – 12 weeks 36 – 48weeks44 – 96weeksSequentialKorea,Republic of4 – 12 weeks 8 – 12weeks20 – 24weeksParallelTaiwan ROC 8 – 16weeks4 – 12weeks20 – 24weeksParallel
    7. 7. FOCUSED. TRUSTED. GLOBAL.6Key Milestone for Clinical Trials – Start-upo Comparison of submission dossier (For IRB)Country EnglishdocumentLocallanguage?Site Budget GCPcertificateHong Kong Yes Yes No NoChina N/A Yes Yes (some) NoKorea,Republic ofN/A Yes Yes YesTaiwan ROC N/A Yes No Yes
    8. 8. FOCUSED. TRUSTED. GLOBAL.7Key Milestone for Clinical Trials – Start-upo Comparison of submission dossier (Forcompetent agency)Country EnglishdocumentLocallanguage?Site BudgetHong Kong Yes Yes NoChina No Yes NoKorea,Republic ofNo Yes NoTaiwan ROC No Yes No
    9. 9. FOCUSED. TRUSTED. GLOBAL.8Key Milestone for Clinical Trials – Start-upo Special requirements during applicationCountry Special RequirementsHongKongSample drug; Import license for biological materials (e.g.tumor block)Korea,RepublicofImport license for lab kitsTaiwanROCImport license for lab kits
    10. 10. FOCUSED. TRUSTED. GLOBAL.9Operational Consideration - Koreao Source documentation and monitoring• National Health Information System (NHIS) – electronicmedical record (EMR) legalized in 2003.• Mainly written in Korean• Study monitor -specific account available formonitoring purpose• Interpreter would be needed if the study monitorcannot read Korean
    11. 11. FOCUSED. TRUSTED. GLOBAL.10Operational Consideration - KoreaLogin page of eMR (Asan Medical Center)
    12. 12. FOCUSED. TRUSTED. GLOBAL.11Operational Consideration – Hong Kongo Source documentation and monitoring• CMS, termed as Clinical Management Systems, isaccessible by clinical users at 43 hospitals and 120 clinicssince 1994.• Investigator and CRCs at HA hospitals are accessible tothe subject clinical data, except those from private sector.• English is used for official documentation throughout thesystem• As of today, both electronic and paper medical recordare used.– OP notes will be printed and signed by the responsiblephysician for archive.– Consideration of 21 CRF part 11 compliance• Monitor has no access to CMS and source dataverification (SDV) will be conducted over paperdocuments.
    13. 13. FOCUSED. TRUSTED. GLOBAL.12Operational Consideration – Hong Kong
    14. 14. FOCUSED. TRUSTED. GLOBAL.13Operational Consideration - Chinao Source documentation and monitoring• Use of eMR for source documentation varies betweenhospitals– Direct data entry to system– Scanning of hand-written electronic medical document• No networked eMR is used in China– Original medical record still replies on referral letter• Retrieval of original medical could be limited tolitigation or other legal issues.• Written in Simplified Chinese• Interpreter would be needed if the study monitorcannot read Simplified Chinese
    15. 15. FOCUSED. TRUSTED. GLOBAL.14Operational Consideration – Taiwano Source documentation and monitoring• eMR is also used. (need data on the popularity fromTaiwan)• Traditional Chinese is used for official documentationthroughout the system• As of today, both electronic and paper medical recordare used.– Consideration of 21 CRF part 11 incompliance• Monitor has no access to CMS and source dataverification (SDV) will be conducted over paperdocuments.
    16. 16. FOCUSED. TRUSTED. GLOBAL.15Operational Consideration – SafetyReportingo Timeline to notify IRBCountry LocalSAE(death/ life-threateningevent)OverseasSAE(death/ life-threateningevent)LocalSAEOverseasSAEHong Kong 15 days 30 days 15 days 30 daysChina 24 hours Not specified 24 hours Not specifiedKorea,Republic of7 days 7 days 7 days 15 daysTaiwan ROC 15 days 7 days 15 days 15 days
    17. 17. FOCUSED. TRUSTED. GLOBAL.16Operational Consideration – Safety Reportingo Timeline to notify competent authority (CA)Country LocalSAE(death/ life-threateningevent)OverseasSAE(death/ life-threateningevent)LocalSAEOverseasSAEHong Kong 7 days (forunexpectedevents)Norequirement15 days (forunexpectedevents)NorequirementChina 24 hours 7 days 24 hours 15 daysKorea,Republic ofNotspecified/annually7 days Notspecified/annually15 daysTaiwan ROC 7 days 7 days 15 days 15 days
    18. 18. FOCUSED. TRUSTED. GLOBAL.17Logistical Consideration in Clinical Supplieso Local drug procurement may be necessarybecause some treatment drugs are notconsidered SOC or unavailable at site. To confirm drug supplies at the time of feasibility Local sourcing for drug supplies and shipmento IP management/ disposal policy within thecountry For cytotoxic drugs
    19. 19. FOCUSED. TRUSTED. GLOBAL.18Logistical Consideration in MedicalEquipment and Specimen Managemento Supply of clinical facilities -80°C Freezer/ centrifuge may not be available at site Application of import license for lab kits (Taiwan andKorea)o Lab specimen shipment Consider application of export license for infectiousspecimen & import for returned tumor block
    20. 20. FOCUSED. TRUSTED. GLOBAL.19Challenges – Treatment Diversityo Most countries follow international standard, butmay also adopt local consideration E.g. Choice of chemotherapy regimen which suitsAsian clinical profile• Breast cancer: choice of anthracycline: epirubicin overdoxorubicin in Taiwan• For further input from Medical advisor• Differences in the understanding of medicationprocedures due to differences in principles/clinicalguidelines and systems of out-patient operations
    21. 21. FOCUSED. TRUSTED. GLOBAL.20Challenges – Treatment Diversityo Dose calculation Maximum dose is too high for Asian patients in someoncology studies.o Use of herbal medicine The use is commonly found in China. It brings safety-benefit issue to the trial subject
    22. 22. FOCUSED. TRUSTED. GLOBAL.21Challenges – Language Barriero Translation China, Korea and Taiwan requires translation onessential documents (e.g. protocol, investigator’sbrochure) Timeline is affected if amendment appearso Data management Inaccurate coding/ translation of symptoms• Incorrect interpretation• DCF generation
    23. 23. FOCUSED. TRUSTED. GLOBAL.22Challenges – Local Clinical Practiceo Patient compliance Lost-to-FU is frequent in Chinao Obtaining informed consent Elder patients may not aware of their medicalconditions, which is chosen not to be disclosed bytheir relativeso Necessity of face-to-face meeting The practice is appreciated at the early stage, e.g.site identification, feasibility
    24. 24. FOCUSED. TRUSTED. GLOBAL.23Best Practices to Maximize Your Worko Efficient feasibility/ site evaluation Seek regional KOL advice/ seek medical advisory Flexibility in protocol design Site staff resource and CRC Source document and eMR Paradigm of study payment Accurate and timely patient transportation fee Clarification of IRB responsibilities and procedures Use of government certified institution
    25. 25. FOCUSED. TRUSTED. GLOBAL.24Best Practices to Maximize Your Work
    26. 26. FOCUSED. TRUSTED. GLOBAL.25Best Practices to Maximize Your Worko Project planning and management To balance global goal and standardized way withlocal requirements and optimization To standardize procedures for diversified operations Levels of operations• Core: protocol, adjunction procedures, central lab• Regional: Monitoring procedures, ICF preparation (e.g.data privacy ordinance), site budget• Local: institutional requirements, local business practices
    27. 27. FOCUSED. TRUSTED. GLOBAL.26Best Practices to Maximize Your Work
    28. 28. FOCUSED. TRUSTED. GLOBAL.27Best Practices to Maximize Your Worko Project planning and management Use of CRO and SMO• To ensure sponsor governance and study oversight.• Blooming use of SMO which provides various services inCRC management, contract and budget & SOP review
    29. 29. FOCUSED. TRUSTED. GLOBAL.28Best Practices to Maximize Your WorkGlobal Lead/ SponsorRegional operations Regional operations Regional operationsLocal Local Local Local Local Local
    30. 30. FOCUSED. TRUSTED. GLOBAL.29Special Consideration for Oncologyo National insurance coverage varies betweencountries, which reflects on the feasibilityassessment, budget and patient recruitment in thefuture. E.g. Prerequisite 1st line treatment for inclusion may not beavailable at site/ in country practice. (use of smallmolecule inhibitor for HCC in Taiwan)o Consideration of lab sample selection of regional central lab to provide lab support forthe region• genetic characterization for specific NSCLC, breastcancer Clear communication about turnaround time The need to re-import the remaining tumor tissue
    31. 31. FOCUSED. TRUSTED. GLOBAL.Q&A
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