Download Why to do Clinical Cancer Research in Developing

Impact of Clinical Trials on
Cancer Care in Low- and Middle –
Income Countries
International Clinical Trials Workshop
FLASCA, ASCO, NCI, ONS.
September, 11-13 2014. Córdoba, Argentina
Prof. Dra. Lucía Delgado Pebé
Directora del Servicio de Oncología Clínica
Hospital de Clínicas - Montevideo, Uruguay
Presidente del Grupo Oncológico Cooperativo Uruguayo
Cancer Incidence
(IARC, 2014)
CANCER year 2012
14.1 million new cases
1.3 million in Caribbean and Latin America
CANCER by the year 2030
21.4 million new cases
1.7 million in Caribbean and Latin America
All Cancer Mortality/Incidence Ratio
(IARC, 2010)
 Latin America: 0.59
 European Union: 0.43
 USA: 0.35
Why to do Clinical Cancer Research
in Developing Countries? (1)
 With regards to other regions there are differences
in incidence and mortality
 The most frequent cancers may be different to those
in developed countries regarding the primary location
and biological characteristics.
Cancer Incidence and Mortality Worldwide
Less vs More Developed Countries
INCIDENCE
MORTALITY
MEN
Cancer Incidence and mortality .UICC, 2005.
INCIDENCE
MORTALITY
WOMEN
Cancer Incidence and mortality .UICC, 2005.
Why to do Clinical Cancer Research
in Developing Countries? (2)
 There can be ethnic differences in drug
metabolization and tolerance to treatment and
differences in response to therapy.
Acces to and coverage of Health Services may
not be similar.
The Relevance of Cancer Research
in Developing Countries
As a consequence, studies conducted in developed
countries may not respond to the needs and
characteristics of the population and Health Systems
in countries with fewer resources
Local research can contribute to identify
treatments that can be useful and also be
affordable in less developed countries
Academic vs Pharma Industry driven
Clinical Research
 As clinical trials have become more expensive, the
proportion financed by the pharmaceutical industry (PI)
has increased.
As a logical consequence, the Pl has a major influence
on topics selected for clinical trials
Why to do Academic Clinical Research?
Treatment guidelines are based on clinical trials
 As a result of the growing sponsorhip of the PI,
there exists an increasing influence of the
commercial sponsors on therapeutic guidelines
Clinical Trials in
Latin America
Academic
Academic
vs Sponsored
vs Pharmaby
Industry
Pharma
Driven
Industry
Pharmaceutical Industry sponsored investigation
is important and should be continued
BUT
Academic, independent investigation should have
a much more important role than the present one
Academic vs Pharma Industry driven
Clinical Research
Pharmaceutical
Industry
Main objectives of industry driven
and academic driven clinical trials
Academy
1. Development of new drugs/interventions
3
2. Development of new therapeutic
strategies (multidisciplinary, new
combinations or indications of know drugs)
3. Rapid incorporation of new discoveries
in clinical practice
4. identification of ineffective/ redundant
therapeutic strategies
Academic Clinical Trials in LA
Main Concern: FUNDING
Therapeutic clinical research is expensive which
makes it difficult to be state funded
HOWEVER
What is the health care cost, if the standard of
care is based on clinical studies that develop non
affordable or non relevant treatments for our
patients?
Example: treatment of advanced
Hepatocellular Carcinoma
Sistemic Therapy of
Advanced Hepatocellular Carcinoma
Estudios
SORAFENIB
N= 137 (Fase II)
JCO, 2006
Poliquimioterapia
con GEMOX
N= 34 (Fase II)
Cancer, 2007
SORAFENIB
Vs PLACEBO
N= (Fase III)
N Engl J Med,
2008
Respuestas
objetivas
Sobrevida
sin
progresion
Sobrevida
global
2.2%
4.2 meses
9.2 meses
18%
6.3 meses
11.5 meses
2.0% vs 1%
5.5 vs 2.8
meses
10.7 vs 7.9
meses
Fase III
(vs Placebo)
Sistemic Therapy of
Advanced Hepatocellular Carcinoma
Open studies:
“SORAFENIB WITH O WITHOUT CHEMOTHERAPY
IN TREATING PATIENTS WITH ADVANCED
HEPATOCARCINOMA”
Source: clinicaltrials.gov
Is GEMOX as efective as Sorafenib?
Why to do Clinical Cancer Research
in Developing Countries?
A) ENSAYOS CLINICOS Academica
PARA REALIZAR ESTUDIOS EN LOS QUE NO SE
INTERESA LA INDUSTRIA FARMACEUTICA
1) IDENTIFICAR FACTORES PREDICTIVOS DE
BENEFICIO CON TERAPIAS QUE HOY SE INDICAN
A TODOS PARA BENEFICIAR UNOS POCOS (EJ
BEVACIZUMAB)
2) PARA IDENTIFICAR TRATAMIENTOS EFECTIVOS
DE BAJO COSTO (ENSAYAR DROGAS DE BAJO
COSTO EN NUEVAS COMBINACIONES O
INDICACIONES (LOS RESULTADOS PUEDEN SER
MUY BUENOS. EJ: DOCETAXEL CON HT EN
PRIMERA LINEA DE CA DE PROSTATA) O
COMPARAR DROGAS DE ALTO COSTO CON
Why to do Clinical Cancer Research
in Developing Countries? (3)
Clinical Research versus use of Clinical Guidelines
in improving outcomes:
• Survival rates of patients treated in centers
participating in clinical trials tend to be better.
Du Bois A et al, Int J Gynecol Cancer 2005
Peppercorn J et al, Lancet 2004
Hebert Croteau N et al, Breast Cancer Res Treat 2005
Fuente: The benefit of participating to clinical reserarch. N. Hébert-Crosteau, J. Brisson, J. Lamaire and J. Latreille.
Breast Cancer Researcha and Treatment (2005) 91:279-281
Better outcomes for patients treated at hospitals that
participate in clinical trials: (a) adherence; (b) mortality.
Selby P , and Autier P Ann Oncol 2011;22:vii5-vii9
© The Author 2011. Published by Oxford University Press on behalf of the European Society for
Medical Oncology. All rights reserved. For permissions, please email:
[email protected]
Why to do Clinical Cancer Research
in Developing Countries? (5)
• Development of research is essential to the
development of a high quality, sustainable, health
system
• Scientifically trained oncologists are more able to
analyze the information and to identify the relevant one
Why to do Clinical Cancer Research
in Developing Countries? (6)
• To obtain data that allows to assess the efficacy and
cost-benefit ratio of any intervention in the natural
history of a disease (what applies in one population or
environment does not necessarily apply in another)
• The questions that need to be addressed to improve
cancer care in developing countries frequently differ
from those that are prioritized in developed ones
The Importance of
Multinational Clinical Trials

In frequent and devastating neoplasms ( a little
improvement in survival may be relevant)

In rare tumors

it substitutes small trials (carried out at the same time
in several countries) that are inconclusive
Clinical Research in Latin America
NEEDS AND CHALLENGES
FLASCA’s Perspectives
 To increase the participation in relevant
multinational clinical studies, that comply with
international ethic norms and with the current local
regulation and conducted by a adequately trained
team
 It should be offered to a greater percentage of
patients, the possibility to participate in these kind of
studies
Clinical Research in Latin America
NEEDS AND CHALLENGES
FLASCA’s Perspectives
To support:
- research programs oriented to the
local/regional problems
- academic clinical studies that take into
account the cancer characteristics at the
local/regional level and treatments that can be
financed in our countries
Thank you!!