Clinical Rubik's Cube: Global Clinical Trials in Hungary
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Transcript of Clinical Rubik's Cube: Global Clinical Trials in Hungary
Clinical Rubik’s Cube
Opportunities and Challenges in Global R&D Studies: Example of Hungary
Dr. Aleksandar Skuban2009
Opportunities multiply
as they are seized.
Sun Tzu
Topics
Global trends in placement of clinical trialsGrowing opportunitiesExample of Hungary: tradition of researchContributionsHealth Atlas 2008Patient BenefitsFuture Prospects
PharmaceuticalClinical Development PsychiatryIntl Clinical Trials Management
Clinical Research OrganizationsTop 10 Global Companies
HungarySemmelweis University Budapest
Background Europe and United States
Placement of Clinical TrialsEmerging, Developing and Mature Markets
Investigator Landscape
*Glickman S W. Ethical and Scientific Implications of the Globalization of Clinical research. N Engl J Med 2009;360:816-823Tufts Center for the Study of Drug Development
CRO Market 2005
L10 MM SM
15.714.9
6.6
Annual Revenue Growth 2002-2007
80%
11%
9%
Largest 10 CROs Medium CROsSmall Companies
Applied Clinical Trials May 2007
Globalization is a Tool(and two-way road)
Rapidly Changing environment
Definitions of Emerging, Developing or Developed Countries
Economy (GDP, IFC, World Bank)Scientific and Ethics Standards International Exposure
BRIC(M) and Beyond
And a knowledge to use it(by all parties)
Regional Differences and Expectations
Benefit for Clinical Development Programs
New Enthusiasm for Problem-Solving
Regional Considerations
Patient AccessCompetent SitesDisease PrevalenceRecruitment SpeedData QualityCostExperience
Universal Challenges
EthicalScientificAccess to Health CareAccess to Tested TherapiesCommercializationLack of ExperienceExploitationData Quality
Glickman S W. Ethical and Scientific Implications of the Globalization of Clinical research. N Engl J Med 2009;360:816-823Shuchman M. Commercializing clinical trials-risks and benefits of the CRO boom. N Engl J Med 2007;357:1365-8
Tailored SolutionsOpen Mind for a Changing Landscape
Value creation vs. Consumer ExpansionCountry Specific Consideration and AssessmentTraining InfrastructureICH-GCPRegulatory oversight
Hungarian Example
CEE, EU, Emerging, DevelopingDiscovered, Re-discovered
Strong Background in Science, Chemistry and Medicine
Tradition of Pharmaceutical Manufacturing
Pharmacology Research
Established Regulatory Framework
Centralized Health Care System
Comprehensive Public Health Policies
Traditional Strengths
Albert Szent-Györgyi von Nagyrápolt Nobel Prize in Physiology or Medicine in 1937.
First to isolate Vitamin C which he found in abundance in Hungarian paprika.
Science, Chemistry and Medicine
1965 First publication by Joseph Knoll in English
1967 Psychiatrist Ervin Varga observed antidepressant action
1971 Selective MAO-B inhibitor
1975 W Birkmayer (Wiena) Effect in PD
1996 Adjuvant Therapy in Parkinson’s Disease (US)
2006 Selegiline patch for depression (US)
Selegiline Story
Am J Psychiatry 1979; 136:196-199 Copyright © 1979 by American Psychiatric Association Comparative efficacy of tofisopam and placeboHL Goldberg and RJ Finnerty
Tofisopam is a new agent marketed in Europe as a minor tranquilizer. The authors conducted a 4-week double-blind trial of this drug compared with placebo in 57 outpatients with anxiety and depression. They found that according to physician ratings and patient self-ratings tofisopam was an effective anxiolytic agent for subjects with anxiety and depression.
Twenty-one percent of the patients receiving tofisopam and 10% of those receiving placebo reported side effects. The drug was especially effective in the treatment of somatic difficulties.
1970s Tofisopam (Grandaxin®)
Lawrenceville, NJ (June 14, 2002)
VelaPharm Advances Development of Tofisopam for the Treatment of Anxiety in the U.S.Preclinical Data Presented at NCDEU, a National Institute of Mental Health/New Clinical Drug Evaluation Unit (NCDEU) General Meeting in Boca Raton, Florida
March 14, 2006
Pharmos to buy Vela Pharmaceuticals for $29.7MOnce the deal is complete, the new company's lead product will be R-tofisopam, a drug that has demonstrated positive Phase II data for the treatment of diarrhea-predominant and alternating-type irritable bowel syndrome (IBS).
R-Tofisopam in Development Today
1901
1912
1913
Pharmaceutical Industry
1990 Hungarian Pharmaceutical Manufacturers Association (MAGYOSZ)
Ministry of Health (2005)
OGYI (National Institute of Pharmacy)
ETT (Medical Research Council)
TUKEB (Scientific and Research Ethics Committee)
KFEB (Clinical Pharmacology Ethics Committee)
ECRIN ( European Clinical Research Infrastructures
Network)
Regulatory Framework Professional Networks
11-12 meetings per year
414 new clinical trials reviewed
1294 “amendments” reviewed
Decisions taken
70% approved15% declined (68 % scientific, 18% ICF, 17%
both)15% withdrawn
Clinical Pharmacology Ethics Committee (2008)
1994 GCP in Hungary
2001 Clinical Trial Management Society Hungary
Founding assembly 23 organizations
2004 Membership in IFAPP International Federation of
Association of Pharmaceutical Physicians
2004 CRA accepted as a profession
2004 Hungary EU member
Professional NetworksRegulatory Framework
Health care expenditure
United Kingdom*
Hungary
Switzerland
Russian Federation
Greece
8.1
7.9
11.5
6
7.9
2560
1308
4011
583
2179
US$ PPP2 % of GDP
Number of nurses and physicians and hospital beds
United Kingdom*
Hungary
Switzerland
Russian Federation
Greece
213
304
397
431
500
499
896
833
806
338
390
792
568
966
473
Hospital beds Nurses Physicians
Per 100 000 population (* UK data from 2002)
Leading physicians and Institutions
Early adoption of GCP guidelines
Excellent Data Quality
High Patient recruitment
Skilled clinical research professionals
Lower cost
Enthusiasm for novel drug development
Contributions in the ‘90s
Clinical Trials in Hungary 1992-2008
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
0
50
100
150
200
250
300
350
Phase I Phase II Phase III Phase IV Bioequiv.Courtesy of Janos Antal, MD, MBA (Parexel Hungary)
New Global Trials Initiated in CEE*
Hungary Poland Russia Romania Ukraine
146213 196
62 47
204
573
725
212
375
2002 2007
Center Watch Data August 2008 (*selected countries)
Atlas of Health 2008 in Europe
(WHO Europe)
Benefit for patients and patient access benefits
Atlas of Health 2008 in Europe Hungary
1st All Cancer , Lung cancer & New Cases
2nd Digestive system
3rd Colon
4th Total alcohol consumption
5th Suicide
Russian Federation (life expectancy at birth, death from all causes, circulatory system, ischaemic heart disease (25-64), suicide)
Deaths from diseases of the circulatory system
Russian Federation
Hungary
France
301.2
175.3
28.6
157.1
47.8
4.9
Females Males
Per 100 000 population (25-64 years)
Deaths from cancer
Russian Federation
Hungary
Sweden
224.5
301.2
86.8
123.3
157.1
102.5
Females Males
Per 100 000 population (25-64 years)
Deaths from lung cancer
Poland
Hungary
Sweden
72
99.7
16.9
20.9
35.3
19.7
Females Males
Per 100 000 population (25-64 years)
Deaths from GI system diseases
Norway
Hungary
Moldova
19.3
105.4
156.9
15
42.4
115.4
Females Males
Per 100 000 population (25-64 years)
Hungary Activity Map(www.clinicaltrials.gov) October 2009
278 active studies
89 cancer studies
21 lung cancer studies
Prospects for clinical research in Hungary
Slightly smaller than Indiana- population 9.9 M
Local, Regional CROs and Pharmaceutical Companies
Competition for Qualified Sites and Patients
Restrictions for Placebo-Controlled Studies
Opportunities
European Integration
Government Support for Clinical Research
Expanding Research Networks and Quality Sites
Accreditation of Phase I (Clinical Pharmacology) sites
Need for more qualified, English speaking personnel
Adjustment to new trends
Expansion Maturing Saturation Migration
Future scenarios
Other (New)Countries and Regions
Growth Rate of New Global Trials Initiated in CEE*
Center Watch Data August 2008 (*selected countries)
Unique
1.1B
2%221 trials in 2007 (Reuters Jan 21,2009)
Technology
Competition
Integration
Outsourcing
Relationships
choice integrity
knowledge
National Institute of Pharmacy http://www.ogyi.huMinistry of Health http://www.eum.hu/main.php Medical Research Council http://www.ett.hu/ Clinical Trial Management Society Hungaryhttp://www.mkvt.hu/http://www.mkvt.hu/admin/data/file/177_clinical_trial_managementsociety_hungary.pdfHungarian Pharmaceutical Manufacturers Organization http://www.magyosz.org/ European Clinical Research Infrastructures Networkhttp://www.ecrin.org/
Useful Links
Thank You
Questions