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Pakistan Clinical Research Capacity

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Pakistan\'s Clinical Research Profile

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Pakistan Clinical Research Capacity

  1. 1. Pakistan Clinical Research Capacity
  2. 2. Pakistan Located in South Asia, Pakistan shares an eastern border with India and a north- eastern border with China. Iran makes up the country’s south-west border, and Afghanistan rune along its western and northern edge. The Arabian Sea is Pakistan’s southern boundary with 1,064 km of coastline. Pakistan displays some of Asia’s most magnificent landscapes as it stretches from the Arabian Sea, its southern border, to some of the world’s most spectacular mountain ranges in the north. Pakistan is also home to sites that date back to word’s earliest settlements rivaling those of ancient Egypt and Mesopotamia.
  3. 3. Basic facts about Pakistan Capital: Islamabad Largest City: Karachi (about 17 million) Total Population: 170 million Area: 796,097 sq. km. National language: Urdu Official language: English Imports: Industrial equipment, vehicles, iron core, edible oil Exports: Cotton, textile goods, rice, leather items, carpets, sports goods, handicrafts, seafood
  4. 4. Population in Major Cities Hyderabad Islamabad Rawalpindi 7% 4% 7% Lahore Major Cities in Pakistan 25% Islamabad : 799,000 : 9,269,265 Karachi : 5,129,214 Lahore : 2,280,360 Faisalabad : 1,447,957 Hyderabad : 1,406,214 Rawalpindi Karachi Faisalabad 46% 11%
  5. 5. Economic Survey of Pakistan Growth rate: 8.4% this is the figure being talked about everywhere - making Pakistan the second fastest growing economy in the world, just behind China. Inflation: 9.1%. Per capita income: $736, almost 12 per cent higher than last years $657. GDP: $123 billion. Literacy rate: 52% Health Budget: Rs. 38 billion (US$ 634 million)
  6. 6. Health Infrastructure
  7. 7. Health Facilities Hospitals in Public Health Sector 916 Rural Health Centers 552 Basic Health Units 5,301 Dispensaries 4,582 Registered Doctors 113,206 Registered Dentists 6,127 Nurses in Public Health Sector 48,446 Majority of doctors and hospitals are located in cities and towns – rural population has much less access to healthcare facilities
  8. 8. Clinical Research Capability and Infrastructure
  9. 9. Ethical Environment Most of the tertiary care hospitals have there own ICH GCP compliant Ethics Committees These committees meet on regular basis Average approval timelines are between 4-6 weeks Ethics committee fee ranges from US$ 500-3000 Regular reports need to be submitted to these committees on study progress and at closeout
  10. 10. Regulatory Approval Process The clinical research wing of the ministry of health Pakistan takes care of the regulatory approval for CTM import as per Pakistan GCP guidelines It is not necessary to obtain a separate approval for the export of biological materials from Pakistan Import license is issued with the approval The approval timelines are between 4-8 weeks
  11. 11. DOCUMENTS REQUIRED FOR REGULATORY APPROVAL 1. Investigator Brochure 2. Final Protocol 3. Informed consent form (English & Urdu) 4. List of participating countries 5. Phase of trial 6. Quantity of Drugs to be imported on form-4 of drugs import & export rules 1976 7. Site of the trial 8. C.Vs of investigators 9. Ethical committee approval with complete composition of committee i.e., names and designations of the members 10. GMP certificate along with free sales certificate/ certificate of pharmaceutical product 11. Preclinical and clinical data and safety studies. 12. Summary of the protocol 13. Summary of the Investigator Brochure 14. Adverse Event Reporting form 15. No. of patients to be enrolled in each center 16. Name of monitors/clinical research associate 17. Evidence of registration in country of origin 18. Copy of registration letter (if registered in Pakistan) 19. Sample of label of drug 20. Duration of trial 21. Fee for clinical trial Rs. 5000/-
  12. 12. Approval Process – Phase I No policy to process Phase I studies at the present: WHY? • Lack of infrastructure and specific facilities within the country • Phase I studies are mainly concerned with the innovative drugs which are mainly dealt by the multinational companies with established research organizations and they have their own priorities to conduct such studies in their specific/notified regions. • The process for approval has been initiated but not yet finalized (National and International assistance has been requested)
  13. 13. Approval Process (Phase-II & III) Application & Protocol submission in the Clinical Trial Section Application & Protocol checked by ADC (CT) Complete Incomplete Firm informed about deficiencies New molecule Registered Expert Evaluation Rejection letter Rejected Approved Issued with observations License issued ADC (CT) of the Expert for the import of drugs to conduct File sent to DDG (R&D) Clinical Trial Drugs Controller (R&D) Director General (Health)
  14. 14. Approval Process Phase IV Application & Protocol submission in the Clinical Trial Section Scrutiny of Application by the ADC (CT) Complete Incomplete Expert Evaluation Firm informed about deficiencies Rejected Approved ADC (CT) Rejection letter Issued With DDG (R&D) Observations of the Expert Licence issued Drugs Controller (R&D) for the conduct of Clinical Trial Director General (Health)
  15. 15. Timelines for Application Scrutiny/ Processing of Clinical Trial Registered Molecule: – Scrutiny of application………………………………7-10 working days – Approval process from DG (Health)……………….7-10 working days New Molecule: – Scrutiny of application………………………………7-10 working days – Expert opinion………………………………… ……40-50 working days – Approval process from DG (Health)………….……7-10 working days Note: In case of any clarification, processing is done accordingly
  16. 16. Clinical Trials Approved by Ministry of Health - Pakistan 20 18 16 14 12 10 8 6 4 2 0 2003 2004 2005 2006 2007 2008
  17. 17. Comparison of Phase II & Phase III Conducted in Pakistan 10 9 8 7 6 Phase-II 5 Phase-III 4 3 2 1 0 2003 2004 2005 2006 2007 2008
  18. 18. COMPANIES CONDUCTING CLINICAL TRIALS IN PAKISTAN 14 12 10 GSK 8 Novartis Pfizer 6 BMS Bayer 4 CRO/DRs 2 Abbott 0 2003 2004 2005 2006 2007 2008
  19. 19. COURIER SERVICES All major courier services are operational in Pakistan i.e., FEDEX, TNT, World Courier etc. Biological specimens can be shipped overseas in Liquid Nitrogen, dry ice, with ice packs or at ambient temperature depending on the requirement of specific specimens Specimens have reached destinations in the US from Pakistan within 48 hours International safety guidelines are followed during transportation of biological specimens
  20. 20. Some Major Research Sites with Phase II and Phase III International Studies Experience 1. NORI, Islamabad 2. Nishtar Hospital, Multan 3. Aga Khan University Hospital, Karachi 4. Jinnah Post Graduate Medical Centre , Karachi 5. Dow University of health Sciences, Karachi 6. Jinnah Hospital, Lahore 7. Lahore General Hospital, Lahore 8. Services Hospital, Lahore 9. Rawalpindi General Hospital, Rawalpindi 10. Lahore General Hospital, Lahore 11. Doctor's Hospital, Lahore 12. Fountain House, Lahore 13. Liaquat National Hospital, Karachi 14. Ziauddin Hospitals, Karachi 15. Al Shifa Hospital, Islamabad 16. Bismillah Taqee Inst. of Health Sciences and Blood Diseases Ctr., Karachi 17. BAQAI Hospitals, Karachi 18. Liaquat National Hospital, Karachi 19. National Medical Centre, Karachi 20. Combined Military Hospital, Rawalpindi 21. Shaukat Khanum Memorial Cancer Hospital, Lahore 22. Cancer Research Group Foundation, Pakistan (working in > 20 hospitals in Pakistan)
  21. 21. Multinational Pharma in Pakistan involved in Clinical Research GSK Pfizer Bayer Novo Nordisk Novartis Sanofi-Aventis Eli Lilly
  22. 22. Major Clinical Research Areas Oncology Neurology Psychiatry Endocrinology Cardiovascular Infectious diseases Ophthalmology Market potential is good for antibiotics, vaccines, analgesics, tranquilizers, hormones, anti-hypertensives, anti-ulcerants, cardiovascular, anti-cancer, psychiatric, contraceptives and birth control drugs.
  23. 23. CROs and SMOs in Pakistan Multinational CROs Parexel APEX International, Taiwan (working through Metrics Research) Kendle International, USA (working through Metrics Research) PRA International, USA (Agreement signed with Metrics Research as subcontractor) Pharm-Olam International, UK (Agreement signed with Metrics Research as subcontractor) Covance, USA (working indirectly, Metrics working at its sites as SMO) Quintiles, USA (have hired local CRAs and will be opening offices soon) PPD is planning to enter the market on their own EPS International, Agreement signed recently
  24. 24. CROs and SMOs in Pakistan Indigenous CRO/SMO Metrics Research (Pvt.) Ltd. www.mrcro.com Have multinational collaboration with CROs and academic institutes Have the capability to conduct and manage preclinical and Phase II,III and IV clinical research in major cities of Pakistan Research cells established in various cities Have the biggest clinical research team after GSK, Pakistan Is the only certified clinical research training provider in Pakistan
  25. 25. Economy of Conducting CR Studies US$ 1 = Rs. 80 40 to 50% economical than US and Europe Clinical research personnel salary structure is less than India Investigator fee is less than or comparable to India All associated tests and scans are much cheaper than US and Europe
  26. 26. The Pakistan Advantage A large diverse and heterogeneous population of Indo-European descent most of who are treatment naive Availability of evaluable patients in numerous therapeutic categories Relatively fast pace of recruitment Low cost in conducting clinical trials A willing population eager to participate in novel drug therapies A government that is proactive that supports and encourages induction of trials such as the ministry of health, trade development authority of Pakistan, higher education commission, and the ministry of labor and manpower English cultural and colonial influence with English as the co-official language and business language of communication
  27. 27. The Pakistan Advantage GCP compliant sites committed to upholding international conventions and ethical standards Lack of regulatory hurdles due to an increasingly accommodating regulatory environment Relaxed duties and taxes on import of test articles and supplies Pakistan’s highly talented English speaking workforce with international post graduate experience Extremely labor and investment friendly environment of Pakistan Low manpower costs High quality of service Good infrastructure with large tertiary care setups
  28. 28. External Economic Drivers for Pharmaceutical Setups Approximately 56,000 doctors - both general physicians and specialists - whose prescriptions are the main sales drivers for the industry A cut in government duties on pharmaceutical raw materials and packing materials Export opportunities due to WTO implementation Manufacturing and marketing of cheaper new generic drugs by National Companies Tax holidays for setting up of new pharmaceutical plants Government setting up new industrial estates specifically for the pharmaceutical industry
  29. 29. 5 Key Reasons to Invest In Pakistan Geostrategic Location Located in the heart of Asia, Pakistan is the gateway to the energy rich Central Asian States, the financially liquid Gulf States and the economically advanced Far Eastern tigers. This strategic advantage alone makes Pakistan a marketplace teeming with possibilities. Trained and Talented Workforce English is the official language and primary means of communication at businesses and educational setups Economic Outlook Pakistan had one of the fastest growing economies of the world having touched a GDP growth rate of 8.4% in 2005. Today Pakistan has 170 million consumers with an ever growing middle class. Foreign investment had risen sharply from an average of $400 million in the 1990s to over $ 3.5 billion in 2005-06. Fiscal deficit had declined from an average 7% of GDP in the 1990s to around 3% in recent years. And FOREX reserves had increased from $3.22 billion in 2000-1 to $13.14 billion in 2005-6.
  30. 30. 5 Key Reasons to Invest In Pakistan Investment Policies Current investment policies have been tailor made to suit investor needs. Pakistan’s policy trends have been consistent with liberalization, de-regulation, privatization, and facilitation being its foremost cornerstones. Financial Markets The capital markets are being modernized, and reforms have resulted in development of infrastructure in the stock exchanges of the country. The Securities and Exchange Commission has improved the regulatory environment of the stock exchanges, corporate bond market and the leasing sector. Whilst the Central Board of Revenue has facilitated structural reform in tax and tariffs and the State Bank of Pakistan has invigorated the banking sector into high returns on investment.
  31. 31. Outsourcing Opportunity The outsourcing opportunities exist in: Contract research & development Bulk drug & formulation manufacture Co-marketing & sales Clinical trials including Technical services like data management Expertise in herbal and nutraceuticals Primary packaging materials Software development
  32. 32. Pakistan Diseases Profile
  33. 33. Top causes of Morbidity and Mortality Mental Illness There are one million severely mentally ill and over 10 million individuals with neurotic mental illnesses within the country (10% among men and 25% among women) Traffic Accidents Furthermore, 1.4 million road traffic crashes were reported in the country in the year 1999. Of these, 7000 resulted in fatalities. Substance Abuse 4.8 million in the year 2000 (growth rate of 7%) HIV HIV/AIDS - adult prevalence rate: 0.1% HIV/AIDS - people living with HIV/AIDS: 74,000 HIV/AIDS - deaths: 4,900
  34. 34. Top causes of Morbidity and Mortality CAD 26.9% in men and 30.0% in women One in four middle-aged adults in Pakistan has prevalent CAD STROKES Raised blood pressure has been observed in 23-64% of the patients suffering from stroke 31-42% were found to be suffering from diabetes 33-53% of stroke patients were current smokers 11-17% were found to be overweight Majority suffered from cardiac disease (46%) and hyperlipidemia (30%) Carotid artery stenosis was observed in 8%
  35. 35. Top causes of Morbidity and Mortality Data on biological risk factors of coronary heart disease and stroke There were an estimated 5.5 million men and 5.3 million women with hypertension in the years 1990-94 The prevalence of hypertension over the age of 15 years was reported at 17.9%, with a higher prevalence observed in urban areas (21.5% vs. 16.2%) Over the age of 45 years, prevalence was reported at 33%, implying that one in every three Pakistanis over the age of 45 years suffers from high blood pressure A.
  36. 36. Top causes of Morbidity and Mortality Obesity In the age group of 25-44 years, 9% of the rural men were overweight compared with 22% of the urban men; for women, prevalence of overweight in rural areas was 14% versus 37% in urban areas When stratified by age, sex and residence, prevalence of overweight was highest (40%) in urban females aged 45-64 year Dyslipidemia 7.3 million people has high blood cholesterol levels 31% of the adults have raised blood cholesterol
  37. 37. Top Causes of Morbidity and Mortality Rheumatic Fever Urban: 22/1000 Rural: 5.7/1000 Diabetes Overall prevalence: 11.47% Tobacco Use in Pakistan 54% men and 20% women using tobacco in one form or the other Thalassemia Five thousand children in Pakistan are born with thalassemia major every year 5-6 per cent of Pakistan’s population is carrier of thalassemia gene
  38. 38. Top causes of Morbidity and Mortality Hemophilia 10,000 cases of hemophilia A and 2,000 case of hemophilia B in the country Malaria 131,179 confirmed cases of malaria from public sector sources in 2003 Tuberculosis Tuberculosis is responsible for 5.1% of the total national disease burden; its incidence is reported at 177/100,000 population whereas the annual mortality on its account has been estimated at 67,500 Hepatitis B and C Common cause of acute hepatitis in Pakistan Hepatitis B positive male volunteer blood donors in Karachi has recently been estimated at 2% Sero-prevalence of HCV in blood donors has been reported at 1.8% Blindness 1.5 million blind people within the country Leprosy 1/100,000
  39. 39. Cancer in Pakistan
  40. 40. Incidence of Cancer in Pakistan Incidence of cancer in Pakistan is 730,956/annum The population of Pakistan has been reported to have the highest rate of breast cancer of any Asian population and one of the highest rates of ovarian cancer worldwide Recessively inherited genes may contribute to breast and ovarian cancer risk in Pakistan
  41. 41. Incidence of Cancer in Pakistan In Pakistani men the 7 most common cancers are: Lung Cancer (18% of all cases) 1. Lymphomas - Hodgkin's disease or Non-Hodgkin's lymphomas 2. (13%) Prostate cancer (8%) 3. Leukemia (6%) 4. Bowel cancer (8%) 5. Bladder cancer (5%) 6. Head, Face and Neck cancers (lip, mouth or throat) (5%) 7.
  42. 42. Incidence of Cancer in Pakistan In Pakistani women the 7 most common cancers are: Breast cancer (34% of all cases) 1. Cervical cancer - cancer of the neck of the womb (6%) 2. Lymphomas - Hodgkin's Disease or Non-Hodgkin's lymphoma (6%) 3. Ovarian cancer (6%) 4. Leukemia (5%) 5. Bowel cancer (4%) 6. Head, Face and Neck cancers (lip, mouth or throat) (4%). 7.
  43. 43. Cancer Treatment Facilities
  44. 44. CANCER RESEARCH GROUP (CRG) DATA Fifteen Common Tumor in Male & Female Total Patient 45883 1995 - 2000 6707 7000 5134 4863 6000 5000 3155 4000 3000 1915 1856 1463 1346 1247 2000 1169 1071 1024 858 672 225 1000 0 us er r ary ma x e er st lon N S a ne S de r vi tat mi CN ST H& dd ea ch Liv Bo ho lad Ov Co Ce ae os Bla Br on mp ll B Pr uk Br ry Ly Le Ga ina Ur
  45. 45. CANCER RESEARCH GROUP (CRG) DATA Ten Common Tumor in Female Total Patient 20903 1995 - 2000 6707 7000 6000 5000 4000 1590 3000 1346 1169 1155 697 2000 672 664 467 293 1000 0 s ar y x r ma t S N S a de as hu r vi mi CN ST H& Ov ho B re ad Ce nc ae mp l lb l B ro uk Ga Ly Le
  46. 46. CANCER RESEARCH GROUP (CRG) DATA Ten Common Tumor in Male Total Patient 24980 1995 - 2000 3979 4000 3273 3500 2688 3000 2500 2000 1247 1218 1192 1170 1071 858 1500 813 1000 500 0 s er er ma te S lon N S ia hu CN ST H& em L iv sta dd Co ho nc B la P ro uk mp B ro Le ry Ly in a Ur
  47. 47. Demographics of Cancer in Pakistan Total Population in Pakistan : 170 Million