Successful Execution Of Clinical Trials In Emerging Markets
 

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Successful Execution of Clinical Trials in Emerging Markets: Operational Best Practices for Clinical Data Capture

Successful Execution of Clinical Trials in Emerging Markets: Operational Best Practices for Clinical Data Capture

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Successful Execution Of Clinical Trials In Emerging Markets Presentation Transcript

  • 1. Successful Execution of Clinical Trials in  Emerging Markets: Operational Best Practices  Emerging Markets Operational Best Practices for Clinical Data Capture Presented by Dwight Cooper and Mark Wade Moderated by Kaarin Gordon September 23, 2009
  • 2. About Lionbridge Global Scale Market Leadership p 4,600 employees 26 countries Leader in $12B services industry • Global network of 25,000 translators • Translation and adaptation of products and content for international markets Hosted Technology Global Clients Web-based language technology Recurring relationships with 500+ platform global clients • Enhances competitive advantage • 80% of revenue comes from recurring clients • Drives efficiency • 12 of the Fortune 20 companies are client Company confidential – distribution prohibited without permission
  • 3. Lionbridge Life Sciences Practice Services Commitment to High Quality Medical translation and localization Quality certifications Linguistic validation / cognitive debriefing Medical terminology databases Internationalization audits Internal LEO Methodology gy Language Quality Services Rigorous SOPs for clinical content Interpretations ISPOR compliant methodology for linguistic validation Life Sciences Expertise Technology Work with leading Pharma, Medical Device, Online portal for project submission, project Biotech, and CROs tracking, and reporting Four dedicated Centers of Excellence Centralized Languages asset management 4,000+ 4 000+ qualified and certified translators ( (TMs, gglossaries, and style g y guides)) SMEs for specialized requirements CMS / LMS connectivity Company confidential – distribution prohibited without permission
  • 4. The FDA and ePRO FDA Guidance 1962: Show efficacy 2006: Involve patient input 2006 I l ti t i t Equally drastic shifts in emphasis In Support of ePRO Choice of recall period (no Parking Lot) Frequency of measurements Degree of respondent/site burden Degree of respondent/site burden “If you don’t know the date it was done, it’s not a diary.” - Robert Temple, MD, Director of the Office of Medical Policy, FDA (CDER) Company confidential – distribution prohibited without permission
  • 5. Value Proposition of ePRO ePRO Technologies & Applications Yield  More Submissible Data Attributable, legible, contemporaneous,  original and accurate (ALCOA) original and accurate (ALCOA) Reduced data variance Real time access to diary data between  y visits Support of adaptive trial designs Generating libraries of experience and  repeatable processes Company confidential – distribution prohibited without permission
  • 6. Fewer Subjects Required with ePRO Insomnia Constipation in men Female Sexual Dysfunction 35% lower standard  Phase III trial called for  Comparison of ePRO and  deviation using ePRO 1,026 subjects paper for sensitive data Study power reached  Approval granted after  Feasibility study;  no  with 56% fewer subjects 322 enrolled  treatment Potential $340,000 in  $ Efficacy was proven with  50% more encounters  savings 69% fewer patients reported with ePRO ISOQOL 2004 “Stating the Art:  ISOQOL 2004 “S i h A Johanson et al., poster presented  J h l d DIA 2003 “Capturing Quality of Life  DIA 2003 “C i Q li f Lif Advancing Outcomes Research  at World Congress of  Using Electronic Data Capture”         Methodology and Clinical  Gastroenterology 2005 F Malik, et al. Applications” S Raymond,               J Pearson Company confidential – distribution prohibited without permission
  • 7. The Elderly and ePRO Average Compliance by Age Group Studies demonstrate  Low Back Pain Study, Subjects Aged 32-93 elderly subjects exhibit  86% 85% 90% 91% 100 high eDiary compliance 90 pliance 80 70 Clients can leverage  Cli t l verage Comp 60 50 40 30 additional usability tools: 20 High resolution screens g Av 10 0 Younger 50-59 60-69 70 or Larger devices, fonts and  than 50 (n=41) (n=41) Older (n=22) Age Group (n=19) targets Thicker stylus pens Company confidential – distribution prohibited without permission
  • 8. PHT Experience as ePRO Market Leader Unparalleled Global Deployment Expertise in 65 Countries p y PHT ePRO solutions deployed We’ll be there soon 60% Oceans and seas of PHT Trials are International Studies St dies Support for 88 languages, including 10 Indic languages First ePRO provider to support Japan‐based clinical trials First ePRO provider to support Japan based clinical trials 200,000 subjects, 20,000 sites 250 standardized questionnaires 250 standardized questionnaires Company confidential – distribution prohibited without permission
  • 9. Global Logistics Country Languages Data Transmissions Transit + Customs Australia English (Australia) Analog, Wireless GPRS 3 to 5 days China Simplified Chinese Simplified Chinese Wireless GPRS Wireless GPRS 5 to 7 days 5 to 7 days Hong Kong Traditional Chinese Wireless GPRS 4 to 5 days India 11 supported languages Analog, Wireless GPRS 5 to 7 days Indonesia Indonesian Analog, Wireless GPRS Analog Wireless GPRS 5 to 7 days 5 to 7 days Japan Japanese Analog, Internet, Wireless 3G 3 to 4 days Malaysia Malay Analog, Wireless GPRS 5 to 7 days New Zealand English (New Zealand) New Zealand English (New Zealand) Analog, Wireless GPRS Analog Wireless GPRS 4 to 5 days 4 to 5 days Philippines Cebuano, Hiligaynon,  Analog, Wireless GPRS 6 to 7 days Tagalog  Singapore English, Malay,  English, Malay, Analog, Wireless GPRS Analog, Wireless GPRS 5 to 6 days 5 to 6 days Simplified Chinese  South Korea Korean Analog, Internet, Wireless 3G 6 to 7 days Taiwan Traditional Chinese Analog, Wireless GPRS 4 to 5 days Thailand Thai Analog, Wireless GPRS 5 to 6 days Company confidential – distribution prohibited without permission
  • 10. PHT Experience in India 17 Studies Since March 2005 122 Sites 122 Sites 11 Languages 1,689 LogPads Bengali English (India) English (India) Mumbai Gujarati Kolkata Hindi Kannada K d Malayalam Marathi Chennai Punjabi Tamil Telugu Urdu (India) Company confidential – distribution prohibited without permission
  • 11. Case Study Large Global Respiratory Study over 400 sites over 3,000 randomized subjects Morning & Evening Diary collect Primary End Point Data Peak Expiratory Flow, Symptoms, Rescue Medication Usage P kE i Fl S R M di i U 3 Standardized Questionnaires Subjects complete questionnaires on eDiary at visits Subjects complete questionnaires on eDiary at visits 40 Countries 46 Languages g g Company confidential – distribution prohibited without permission
  • 12. End Result: No Data Differentials Best Practices for Collecting PRO Data in Emerging Markets Leverage Experienced Vendors Leverage Experienced Vendors Select Most Practical PRO Modality Involve Translation and PRO Experts Early in Cycle Involve Translation and PRO Experts Early in Cycle Specific Recommendations for China & India Define request for written vs. spoken language Challenges with Indic Fonts: Glyphs and Combining Rules Plan for Longer Lead Times to find Subject Matter Experts Company confidential – distribution prohibited without permission
  • 13. Challenges of Delivering Modalities in  a Validated Study If 20‐30% of clinical trials are conducted in Eastern Europe, Asia,  and Latin America (Thomson CenterWatch) And 40% of all clinical trials have an EDC element to them……. Then we must be validating QoL instruments on multiple devices  for use in multiple modalities for use in multiple modalities Company confidential – distribution prohibited without permission
  • 14. The Story Today 20‐30% of Clinical Trials are conducted in Eastern Europe, Asia,  and Latin America (Thomson CenterWatch)  2% of clinical trials are taking place in India; by 2012 that figure  will rise to 8% 40% of clinical trials have some EDC element  40% of clinical trials have some EDC element Larger drug naive population pools Ways to reduce cost and reduce timelines  y Company confidential – distribution prohibited without permission
  • 15. What the Future Holds Multi‐geographic trials are here to stay For multiple reasons, EDC is now and will continue to be  an integral part in any trial Multiple language capability is critical Translation of validated instruments is at the forefront of  T l ti f lid t d i t t i t th f f t f the battle Company confidential – distribution prohibited without permission
  • 16. EDC Differing Modalities Currently three widely accepted modalities Web PDA/tablet device Interactive Voice Response System (IVRS) Company confidential – distribution prohibited without permission
  • 17. Challenges with Each Technology Web Relies on Internet connection There are some populations where  computers are rare Some sponsors have taken to “loaning”  S h t k t “l i ” patients laptops Unfamiliarity with technology Silver surfers; technology inexperienced  patients Certain disease states do not lend  Certain disease states do not lend themselves to “mice” or other devices  (stylus); e.g., RA studies Company confidential – distribution prohibited without permission
  • 18. Challenges with Each Technology PDA/Tablet device Logistically challenging to disperse  loaded Logistically challenging to disperse “loaded”  in market Certain disease states do not lend  themselves to “mice” or “styli”; e.g., RA  h l “ ” “ l” studies Small screen real estate can be a challenge  Small screen real estate can be a challenge to render certain questionnaires Especially ones that incorporate visual scales  (EQ5D) Company confidential – distribution prohibited without permission
  • 19. Challenges with Each Technology IVRS Require DTMF telephones to receive data Set‐up time can be longer by way of sourcing and recruiting  voice talent Patients admit losing concentration during long questionnaires Patients admit losing concentration during long questionnaires Voice talent must ensure they do not pre‐suppose an answer  from a patient Mental health questionnaires are the greatest challenge for IVRS Company confidential – distribution prohibited without permission
  • 20. Common Factors What do all these modalities have in common when it comes to  measuring QoL with a validated scale? ISPOR methodology for  translating validated  instruments Company confidential – distribution prohibited without permission
  • 21. ISPOR Guidelines Were Designed in a  Paper World ISPOR guidelines speak directly to the  methodology for translating a validated scale  gy g but make no mention of how one should deal  with a totally different medium Web and PDA tablet device Web and PDA tablet device It used to be a question of ensuring that a  question didn’t run over into two screens on a  PDA  PDA What's the similarity of a PDA screen and a  paper questionnaire? Very little! IVRS How do we validate voice talent? Company confidential – distribution prohibited without permission
  • 22. The Challenge EDC and multi‐geographic trials are the  p present and the future Paper is the benchmark Instruments are already under significant  stress Industry guidelines need to be augmented Which modality do you use? Which modality do you use? Company confidential – distribution prohibited without permission
  • 23. Knowledge Center www.lionbridge.com Download White Papers Download White Papers • Building Stronger Brands Around the World: A Guide  to Effective Global Marketing • Strengthening Global Brands: Key Steps for  Meaningful Communications around the World • Building a Global Web Strategy: Best Practices for  Developing your International Online Brand • Machine Translation: Saving Time Lowering Costs Machine Translation: Saving Time, Lowering Costs,  and Improving Services View Webinars • Localization 2.0  • The Art and Science of Global Navigation • The Best Global Web Sites (and Why) Company confidential – distribution prohibited without permission