Current situation of Clinical Research in Latin America International Clinical Trials Workshop...
-
Upload
marcus-pitts -
Category
Documents
-
view
217 -
download
0
Transcript of Current situation of Clinical Research in Latin America International Clinical Trials Workshop...
Current situation of
Clinical Research in
Latin
America International Clinical Trials Workshop FLASCA, ASCO, NCI, ONS.
September, 11-13 2014. Córdoba, Argentina
Prof. Dra. Lucía Delgado PebéDirectora del Servicio de Oncología Clínica
Hospital de Clínicas - Montevideo, Uruguay
Presidente del Grupo Oncológico Cooperativo Uruguayo
Research and Health Development in Latin America
PRESENT SITUATION
Biomedical research: - there are countries with highly qualified
investigators, well equiped laboratories and acceptable funding
Clinical, Epidemiological and Health System Research:
- conditions are lacking in many areas: especially funding
- represents only ~ 10% of the entire research
Especially phase III trials
Less participation in phase I and early phase II studies (requiere high levels of specialization and excellent infraestructure)
From the 90’s: international clinical trials (era of the “mega trials”)
Little participation in the conception, design, analisis of the results and authorship (most
Clinical trials generated out of LA)
Evolution of Clinical Trialsin Latin America
PubMed + LILACS
N°
public
/mill
ón h
abit
USA B,F,G, I,S,UK A,B,C,P,Uy LA group: 8 and 6 times less than USA and EU group
Publications on Cancer
2009-2013
PubMed + LILACS
Nº/
mill
ion
inha
b
USA B,F,G, I,S, UK A,B,C,P,Uy
LA group: 40 and 30 times less than USA and EU group
N°t
rials
/mill
ion inhab
LA group: 17 and 14 times less than USA and UE group
USA B,F,G, I,S, UK A,B,C,P,Uy
No of studies in the world: 174.443http:// www.clinicaltrials.gov Accessed: setiembre 2014
Growing interest of developed countries to integrate LA in international studies:
- Increasing number of cancer cases
- Qualified human resources
- Investigational quality similar to developed countries
- Less number of competitive studies
Clinical Trials in LA
CURRENT SITUATION
So, participation in clinical trials generated outside LA, has increased
Hartmann M, Hartmann-Vareilles F. www.plosclinicaltrials.org. 2006Nature Reviews Drug Discovery 2008; 7, 13-14
However:
The proportion of publications from LA has not significantly changed, nor intellectual participation in multinational clinical trials conception, design and result analysis
Limited or no development of clinical trials generated in LA persists
Clinical Trials in LA
CURRENT SITUATION
PubMed + LILACS
Nº/
mill
ion
inha
b
USA
European Group
LA Group
2000-2004 2009-2013
Survey on Challenges to Clinical Trials
ASCO International Affairs CommitteeSeruga B, Sadikov A, Cazap L, Delgado L, Digumarti R, Leighl N,
Meshref M, Minami H, Robinson E, Yamaguchi N, Pyle D, Cufer T.
• Web-based survey• 300 oncologists from 24
countries.
• 80 responders: 41 from HIC and 39 from LMIC
• 90% from academic hospitals
With regards to academic clinical trials, lack of finances reported as the most important obstacle and lack of patients as the less important in both, HIC and LMIC.
Academic Clinical Research In Latin America
Main Barriers
Insuficient funding
Regulatory Framework
(costs, administrative obligations)
Research team structure, training and
dedication
Some countries do not have specific funding for investigation in health and in those that do, the amount is insuficient
Academic Clinical Research in LA
Main Barriers: FUNDING
• WHO: advises to invest in health research and development at least 2% of the cost in Health• Most LA countries dedicate less than that. i.e. Uruguay has dedicated ≈ 0.1%
Fernández J.E. Estructura del funcionamiento y gasto de la
investigación biomédica. Facultad de Medicina. Uruguay, 2005.
2000 2010
Argentina 0.49% 0.61%
Uruguay 0.26% 0.40%
Brazil 1.01% 1.16%
Colombia 0.12% 0.19%
LA and Caribbean 0.50% 0.75%
Spain 0.90% 1.38%
USA 2.70% 2.89%
Research and DevelopmentState Funding - % GDP
(RICYT, 2010)
2000 2010
Argentina 34 57
Uruguay 14 48
Brazil 38 128
LA and Caribbean 23 66
Spain 132 412
USA 938 1306
Research and DevelopmentState Financial– US dollars/inhabitant
(RICYT, 2010)
Table 8. Priorization and relative investment ($PPA), 2006
Lack of adequate funding has been one of the main obstacles for the development of academic clinical trials
Main costs that reduce the possibility of independent research (mostly associated to current legislation):
- Drug supply (experimental, standard) - Insurance policy coverage
- Administrative and structural costs
Academic Clinical Trials in Latin America
INSUFICIENT FUNDING
The cost increase of the clinical trials is paralell with the raise in the proportion sponsored by the Pharmaceutical Industry (PhI).
Clinical Trials
FUNDING
In Latin America, the proportion of clinical studies financed by the PhI is far superior to the one observed in the developed countries.
Cancer Clinical Trials (open interventional studies)
Financial Sources
Register: clinicaltrials.gov (September
2014)
USA:38% EU Group:59% LA 76%
Pharmaceutical Industry
Pharmaceutical Industry
Argentina (75/83) 90%Brazil (116/179) 64%Chile (23/25) 90%Uruguay (5/6)
Register: clinicaltrials.gov (9/2014)
Several LA countries have regulatory policies that garanties the safety of its patients
These policies are established through their health agencies/ministeries
Clinical Trials in LACURRENT REGULATORY
FRAMEWORK
Clinical Trials in LARegulatory Framework:
Main Agencies
- Argentina: ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
- Brazil: ANVISA (Agencia Nacional de Vigilancia Sanitaria) - Colombia: INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)
- Peru: INS (Instituto Nacional de Salud)
- Uruguay: MSP/Dpto. de Evaluación de Tecnologías
- Chile: ISP (Instituto de Salud Pública)
Clinical Trials in LARegulatory Framework
Revision Process: Limiting Steps
• In some LA countries the revision process is secuecial: 1° Ethics Committee (EC) , 2° Competent authority (CA) (step that takes the most time).
• In USA and the EU the revision process is parallel, that means that the communications to the EC and the CA can be done at the same time (Limiting step: revision by the EC)
D. Hurley, RAPS 2008
Cámara Argentina de Organizaciones de Investigación Clínica, 2011
Average time of approval (*) (months)
Country
5 -6Peru
3 – 4Mexico
4.5– 5.5Chile
8 – 10.5Brazil
5.5 – 6.5Argentina
Clinical Trials in LARegulatory Framework
Revision Process:
Average Time
(*) EC + Competent Authority
Cámara Argentina de Organizaciones de Investigación Clínica, 2011
Clinical Trials PRESENT REGULATORY
FRAMEWORK
……
• Clinical trial costs
•Complexity and workload for clinical trials activation
•Delays in clinical trials activation (4 to 11 months)
• Workload for SUSARS’ management
• Quality improvement of clinical trials
• Increase in patients’ protection
• Contributes to harmonizing its conduction
Exponential increase in…
??
Cortesy of T Cufer
Clinical Trials in Latin America
EDUCATION AND TRAINING
Current Situation of Clinical Research in LA
Conclusions
Clinical trials represents an even smaller proportion and almost a 100% are conceived, proposed and financed outside the region
It represents a small proportion of cancer research (<10%)
In 80% of them, the Pharmceutical Industry is the main sponsor
A greater participation of LA researchers is necessary in the conception, design and results analisis of international clinical trials
Investigación Clínica en Uruguay y América Latina
Conclusions
Academic independent clinical trials support is needed: - Education and training of research teams
- Adequate funding (state, hybrid)- Regional harmonization of an
adequate regulatory framework- Institutional support
Thank you!!Thank you!!
International Clinical Trials Workshop FLASCA, ASCO, NCI, ONS.
11-13/9/2014. Córdoba, Argentina
Prof. Dra. Lucía Delgado PebéDirectora del Servicio de Oncología Clínica
Hospital de Clínicas - Montevideo, Uruguay
Presidente del Grupo Oncológico Cooperativo Uruguayo