Implementing EDC in emerging global regions Nermeen Varawalla, MD, PhD, MBA Vice President, Corporate Development PRA International East Coast Annual EDC & Beyond, November 2006
Agenda: EDC for clinical trials in the emerging world Increased participation of emerging countries in global clinical development Value of EDC in emerging world clinical development Implementation of EDC in emerging countries Looking ahead 2
Emerging world clinical development: the balancing act Attractions Large patient populations with diseases of both developed and developing world Fewer competitor trials Motivated investigators Potential for cost savings High growth markets of tomorrow Challenges Nascent clinical development environments Prolonged regulatory processes Relatively poor commercialisation potential Ethical dilemmas Concerns regarding Intellectual Property protection 3
Concerns regarding the use of emerging countries are being addressed. Concerns Quality Progress Data for pivotal studies accepted by the FDA / EMEA Regulatory Approvals Intellectual Property Protection Successful FDA audits Regulatory approval process becoming more streamlined Evolving IP Protection Legislation Ethics Strengthening of Ethics Committees & GCP compliance Training initiatives for research staff and investigators 4
Capabilities needed to conduct global clinical trials in emerging countries. Thorough local knowledge Deep relationships with local physicians / sites Expertise in clinical development for FDA Local application of global processes & systems Tools to monitor, support and train site staff on a real time basis Mexico Brazil Argentina Chile Poland Russia Hungary Other CEEC South Africa China India SE Asia 5
Value of EDC in clinical development Speed Quality Cost Immediate to prompt query resolution Allows continuous and parallel data processing Data base lock in days not weeks from last patient visit Improves initial data quality Real time access to sites Review data during patient accrual More efficient monitoring Queries reduced by 70 90% Removes need to collect and transport paper CRFs 6
Value of EDC: enabler of globalisation Control Communicate Accommodate Enables site to provide better data quality with minimal travelling Allows early identification of bottlenecks Facilitates clinical trial supply management Removes site isolation by fostering communication and co-operation Support sites irrespective of location / time zone Timely reporting of SAEs Collect & analyse data in different languages Work with sites with varying processes Allows flexibility with definition of roles & responsibilities 7
Ease of EDC implementation in emerging regions Requirements exist High speed internet connectivity at sites IT literate clinical research personnel Impediments absent No legacy biases / no scars from late nineties Few recalcitrant investigators Incentives abundant Sites welcome real time support Appreciate being part of the global clinical research community Experience to-date Good uptake at site level Enthusiasm for widespread adoption 8
EDC technology features of value in emerging countries. Advantageous Technology for Implementing EDC in Emerging Countries Simple Thin client technology beneficial although zero client even better Flexible Hybrid paper / electronic systems Provision to use in all combinations paper or EDC sites in a given study on line query resolution sponsor access through EDC interface on paper studies feasibility studies Site driven Technology agnostic: hardware, browser Ability to customise ecrf design 9
Implementation in emerging countries: Best practices Minimise provisioning Reduce dependence on global vendors Encourage local solutions Communication with sites Inform Train Involve Facilitate customisation Maintain the minimum necessary global standards Training modules tailored to address site specific needs Encourage re-definition of roles at the site level with multitasking 10
PRA Flex DMS developed to support emerging world clinical trials 11
EDC in emerging countries: potential hurdles Training at site Nascent global clinical trial environment Busy clinical work loads Motivation and enthusiasm exists PC access Security of equipment System access sharing investigator passwords with site staff Software demands of multiple languages Mandarin 3 bytes Financial Investment Infrastructure internet access / PC Training & Support 12
India presents compelling clinical data management opportunities The case for off-shoring global data management to India Large and growing resource pool Highly developed process innovation skills Credible data quality Operational flexibility to manage crunch periods Cost effectiveness Software options Established data management software e.g. Oracle Clinical, Clintrial, PRA Flex DMS Range of services available Data entry & verification Statistical analysis, medical writing, software programming 13
Global data management services in India: tested service models Global CROs With global data management centres, e.g. Quintiles, PRA Pune Local CROs Offer project based services as well as insourcing Long term preferred provider contracts Pfizer with Cognizant Technologies for data management and statistics Wyeth outsourced the global data management function to Accenture who is servicing the contract with 400 staff in India at 3 locations In house data management functions GSK's data management center, Bangalore supports over 36 global studies Novartis rapidly increasing the number of resources in India Organon performs two-thirds of their data entry in India, have overcome teething issues with data verification 14
Beyond EDC India could contribute to etechnology innovation - Etechnology Drivers in India - Resources Man power Scientific and technical workforce in India is 3 million strong 75,000 biomedical undergraduates and 45,000 pharmacy students Investment State incentives R&D investment soon to reach 2% of GDP Foreign investment abundant Capabilities Proven world beating record in IT delivery Process innovation skills World class internet connectivity Environmental Factors to foster innovation Tradition of boot strapping Exponentially growing demand Global joint ventures, alliances & partnerships 15
Tomorrow s Etechnology opportunities. Solutions for the Clinical Development Sector in the Emerging World Patient recruitment animated, patient information web tools in multiple languages Patient retention mobile telephone based tools to follow patient progress & ensure compliance Product commercialisation facilitate conduct of expanded access programs enable cost effective penetration of high volume / low revenue markets 16
Questions.. Dr Nermeen Varawalla, MD, DPhil (Oxon), MBA Vice President Corporate Development, PRA International Pacific House Imperial Way, Worton Grange Reading, Berkshire RG2 OTD, UK 6 th floor Sterling Center Dr Annie Besant Road, Mumbai 400 018, INDIA tel: +44 7900 227783 email: varawallanermeen@praintl.com website: www.prainternational.com 17