June, 2006
Clinical Studies – Geographic Distribution
• In the world: + 15.000 clinical studies in progress
– Applied Clinical Trials, April 2003
• Number of global studies increased 11.7% from
March 2004 to March 2005
- Applied Clinical Trials, June 2006
Clinical Studies in U.S.A.
• 32.240 clinical studies are listed in the
ClinicalTrials.gov
• 20.463 clinical studies in U.S.A. are, at this
moment, in planning or in opening phase
• 9.594 clinical studies in U.S.A. are, at this
moment, enrolling patients
• 491clinical studies in South America are enrolling
patients
ClinicalTrials.gov 16 August 2006
Increasing Demand
• More than 600 new drugs for treatment of
cancer are in development this year.
• More than 650 clinical studies are in
progress for breast, lung and prostate
cancer
• 238.000 patients are necessary to
complete those studies
Clinical Trials for Cancer Running Out of
Volunteers, CenterWatch, July 2006
ANVISA
Special communication (CEs)
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PRIMARY LOCATION
Estimated New Cases per year
NEOPLASIAS
Male
Female
Total
-
48,930
48,930
Lung
17,850
9,320
27,170
Stomach
14,970
8,230
23,200
-
19,260
19,260
Prostate
47,280
-
47,280
Colorectal
11,390
13,970
25,360
Esophagus
7,970
2,610
10,580
Leukemia
5,330
4,220
9,550
Oral Cavity
10,060
3,410
13,470
Melanoma
2,710
3,050
5,760
Other Locations
61,530
63,320
124,850
179,090
176,320
355,410
55,480
61,160
116,640
234,570
237,480
472,050
Breast
Cervix
Subtotal
Skin
ALL NEOPLASIAS
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Gastrointestinal and Other malignances
Incidence of new cases by site in 2005
CID-1O 2nd. editionCity
New cancer cases per site by topography
Total
Salvador Fortaleza BH1
BH2
P. Alegre Ja
1
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C16Stomach
C18Colon
C20Rectum
C22Hepatocarcinoma
C25Pancreas
C28Anal Canal
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18
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156
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112
92
108
260
174
98
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Other malignances
C34Bronchial tubes and Lungs
C43Melanoma
C44Skin
C50Breast
C53Cervix
C56Ovary
C61Prostate
139
22
30
417
32
69
317
159
105
75
24
139
226
57
# of Sites
S‹o Paulo Piracicaba
Limeira
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2,592
5,226
1,593
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408
287
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18
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106
12
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GI malignances
564
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25
131
27
14
908
217
62
115
83
481
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1,866
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1,346
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1. Accelerated study initiation and enrollment
2. Consistent research excellence, quality and compliance
(international standards; pivotal programs)
3. Sponsor performance and accountability
4. Patient and site management time and expense savings
5. Real time information and communication
6. Comprehensive and cost effective Latin American CRO
services
7. Contribution to national and international oncology
research capacity, expertise and patient care
June, 2006
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Frederico Costa, MD Director of Medical Research