Meeting the challenges at investigative sites: the situation in Asia : Meeting the challenges at investigative sites: the situation in Asia Nermeen Varawalla, MD, DPhil (Oxon), MBA Vice President, Corporate Development, PRA International Applied Clinical Trials European Summit Amsterdam, October 2006
Meeting challenges at investigative sites in Asia : Meeting challenges at investigative sites in Asia Leveraging the opportunities
Recognising the potential hurdles
Defining approaches to effectively work in Asia
Looking ahead
Agenda
Including emerging geographies for late stage clinical trials: the balancing act : Including emerging geographies for late stage clinical trials: the balancing act Nascent clinical development environments
Prolonged regulatory processes
Relatively poor commercialisation potential
Ethical dilemmas
Concerns regarding Intellectual Property protection
Large patient populations with diseases of both developed and developing world
Fewer competitor trials
Keen investigators
Potential for cost savings
High growth markets of tomorrow
Attractions Challenges
Access to large patient populations enables rapid recruitment. : Access to large patient populations enables rapid recruitment. 3 million diagnosed cases
0.7 million new cases are detected every year as compared to 1 million new cases detected in the US
Cancers of the oral cavity, lung, and cervix form over 50% of cases
Other common cancers are those of the breast, head & neck and pancreas
The comparatively less intensive medical surveillance suggests the true cancer caseload would be significantly higher
Standard of care not dissimilar to US and Western Europe
- Example: Cancer in India - The speed of patient recruitment for oncology clinical trials in India is up to seven times faster than in the United States.
Asia has motivated physicians keen to participate in global clinical trials. : Asia has motivated physicians keen to participate in global clinical trials. India has over 500,000 medical doctors, 171 medical colleges and 17,000 medical graduates each year
Medical education in India is delivered in English - based on the British system
Majority of physicians are well trained, fluent in English and computer literate
Most of India’s leading specialists have received post graduate medical training in the USA or UK
A large and growing number of GCP (Good Clinical Practice) trained physicians keen to participate in international clinical trials
Physicians are able and willing to meticulously adhere to study protocols
Strong patient-physician relationships encourage high levels of patient retention - Example - Medical Workforce in India -
Healthcare delivery facilities in Asia are suited for global clinical research. : Healthcare delivery facilities in Asia are suited for global clinical research. Mixture of private and state subsidised healthcare
The vast majority of specialist care is provided by state funded general hospitals at a fraction of developed world costs
University teaching hospitals with state of the art facilities & technologies and hundreds of in-patient beds provide diagnostic, therapeutic and support services in all major therapeutic areas
Private healthcare is of a world class standard
Hospital centric healthcare model
About 70% of hospitals are in urban areas
Patients from rural and small town settings travel to urban specialist centres for treatment
Community healthcare delivery differs from the Western model
Recent investment has equipped Asia’s hospital to developed world standards but at relatively low costs
The cost of health care provision in India one-third that of the Western world
Health insurance coverage is low
Asia offers a wide choice of investigative sites. : Asia offers a wide choice of investigative sites. INDIA CHINA East ASIA Queen Mary University Hospital, Hongkong with 1400 beds serves a population of 1.5 million people Singapore’s National University Hospital - a 930 bedded acute and specialist hospital Veteran’s General Hospital, Taipei, Taiwan has 440 specialists, 300 beds, 2.5 M patients attend out patients clinics and 1 M receive in patient care per year
The National Taiwan University Hospital has 4,000 staff serves approximately 0.6 M inpatients and 2.4M outpatients per year Renji Hospital, Pudong Shanghai has 1,000 beds & 2,300 staff
Ruijin Hospital, Shanghai has 1,385 beds & 3,242 staff
Peking Union Medical College Hospital is upgrading to better serve international sponsors
Sites in metropolitan India are becoming experienced and busy. : Sites in metropolitan India are becoming experienced and busy. Mumbai New Delhi Bangalore Ahmedabad Hyderabad Key Oncology Sites in Main Cities
Tata Memorial Hospital, Mumbai is ideal for oncology studies. : Tata Memorial Hospital, Mumbai is ideal for oncology studies. 25,000 cancer patients visit each year not only from India but also neighbouring countries
1000 patients attend out-patients clinics each day
441 in-patient beds
10,000 major operations each year
5,000 radiotherapy and chemotherapy treatments delivered each year
Equipped with spiral CT scanner, gamma cameras, linear accelerator, bone marrow transplant facilities etc.
The Clinical Research Secretariat co-ordinates clinical research activities that have been reviewed and approved by the Scientific Review Committee and Ethics Committee
Clinical sites are being developed away from the main metropolitan areas. : Clinical sites are being developed away from the main metropolitan areas. Pune Lucknow Jaipur Hyderabad Kochi Key Oncology Sites in India’s “2nd tier” cities
Slide11 : Global clinical trial activity in India is exponentially increasing. No. of global oncology clinical trials conducted at Nizam Institute of Medical Sciences, Hyderabad, India (N = 45) Phase
The nascent clinical trial environment underlies the challenges in Asia. : The nascent clinical trial environment underlies the challenges in Asia. Regulatory approval process more streamlined & predictable
Study start up 12 weeks from regulatory submission
Regulatory approval timelines need to further decrease, particularly in China Government initiatives to strengthen ethics committee approval processes
Recognition of critical importance of informed consent
Overall benefit to healthcare delivery Data for pivotal studies accepted by the FDA / EMEA
Successful FDA audit in India, Taiwan, Hongkong – no findings
Investment in education & training: state & private Quality Regulatory Approvals Ethics India appears to be committed to uphold and enforce Intellectual Property protection as per international standards
Although China too appears intent to protect IP sponsors remain sceptical IP Protection
Smart design of a global late stage clinical trial that includes Asia. : Smart design of a global late stage clinical trial that includes Asia. Divide patient enrolment between North America, Western Europe & Emerging Countries – “1/3rd each”
Include 4-5 Emerging regions
Include at least 10 centres / region to enrol at least 100 patients
Utilise study start up time to identify investigators & subjects
Confirm protocol feasibility
Ensure resources are in place
Initiate the trial in the US – FDA IND valuable
Perform the vast majority of global data management in India
Reduce patient recruitment times
Address commercial imperatives
Mitigate risk
Capture efficiencies
Goals Actions
Access to an experienced investigator pool who maybe utilised for numerous trials is valuable. : Access to an experienced investigator pool who maybe utilised for numerous trials is valuable. Recognise that the physician, investigator and KOL are almost always different individuals
Experienced investigators are a valuable asset
costs of identifying, assessing and training an investigator are rising
contracting and operational processes are faster second time around
better able to forecast patient enrolment
better able to meet expectations aided by site support staff
Pool of investigators needs to continually extended
across geographies
across experience levels
Managing Investigator Networks
Building & Nurturing Investigator Networks in Asia. : Building & Nurturing Investigator Networks in Asia. Recognising critical importance
Patient Access
Data Quality
Ethical Integrity
Growing the Investigator Pool
Pro-active acquisition
Training
Nurturing Investigator Networks
On-going training / education
Fair reimbursements
Site level support – research fellows, study co-ordinators
Investigator & Site Relationship Management
Sound feasibility and site assessment underpins satisfactory data quality. : Sound feasibility and site assessment underpins satisfactory data quality. Meticulous Process
Questionnaire designed to assess prevalent patient profiles, treatment practices and ethical questions
Verification against literature, previous experience and other investigators
Supporting Tools
Centralised fax service
Designated website with differing access levels
Nurture Goodwill
Value of time and knowledge recognised
Use a “ballpark” feasibility as a precursor when study intent is uncertain
Relationship driven
Contingency plans
Back up sites & countries
Growth of the global clinical research sector benefits the Asian patient. : Growth of the global clinical research sector benefits the Asian patient. Treatment arm study participants access biomedical innovation
All participants enjoy improved care
Injection of resources into local healthcare system
Standards of medical practice improve: communication, record keeping, evidence based medicine
Not exploitation! – provided ICH GCP standards are followed: informed consent, expanded access
Concerns about the functioning of Ethics Committees are being addressed. : Concerns about the functioning of Ethics Committees are being addressed. Local Ethics Committee exist in > 200 clinical centres
ICMR (Indian Council for Medical Research) to
review & audit the functioning of ECs
introduce a national accreditation system for ECs
develop the Independent Forum for Ethics Review Committees, a training body
Revised Schedule Y of Drugs and Cosmetics Act has prescribed
roles and responsibilities of ECs
composition as per ICH GCP guidelines
formats for the EC approval letter India Example
Looking ahead : Looking ahead Compelling fundamentals will drive the growth of the clinical development sector in Asia – in particular India
International players will continue to contribute to development of the sector
Initiatives to address regulatory, ethics and IP protection issues will be invaluable for the further growth of the sector
The sector will contribute to an overall improvement in healthcare delivery
Questions….. : Questions….. Dr Nermeen Varawalla, MD, DPhil (Oxon), MBA
Vice President Corporate Development,
PRA International
Pacific House
Imperial Way, Worton Grange
Reading, Berkshire RG2 OTD
tel: +44 118 918 1025
fax: +44 118 918 1001
email: varawallanermeen@praintl.com
website: www.prainternational.com