Thursday, May 12, 2011

52 Perspectives: “Clinical Research in Latin America”

Partnerships In Clinical Trials Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions!

52 Perspectives: “Clinical Research in Latin America”

This contribution to ’52 Perspectives’ comes to us from Celso Arabetti, Valentina Jaramillo, and Horacio Lampe - the management team at Investigacion Clinica LATAM.com. Investigacion Clinical LATAM’s has the widest reach into the world of clinical research in the Latin America region. It’s mission is to provide the industry with useful resources about clinical research in Latin America in a fun, practical, and user friendly manner.

Clinical Research in Latin America

Over the past years, Latin America has grown in the Clinical Trial’s business. More pharmaceutical companies and Clinical Research Organizations are running successful trials in the region and the future looks promising. However, in the last two years the number of studies decreased due to the global crisis plus the complexity of the regulatory process, particularly in Brazil and Argentina which were the leading countries of the region.

The LATAM Advantage

Some of the advantages of performing clinical trials in Latin America as a region are that it is still cost efficient regarding patient enrollment, the disease patterns are similar to the United States and Europe, there are highly experienced investigators, doctor-patient relationships are really good, the patient retention rate is high, there is access to a large number of patients, and the quality of the data is also high. All of these reasons make Latin America a very attractive region to the pharmaceutical industry, and the importance of the region as a pharmaceutical market should also be highlighted.

Challenges…

But not everything is nice and easy. There are several challenges for the region to overcome if it wants to stay competitive. The regulatory process is the main problem holding back the region. If there is commitment from all the stakeholders to improve their share of this process by making it as effective as possible, if standards are decided for all Latin America’s countries and if instead of working as separate entities the region unites, then Latin America will overcome its challenges and why not, become the leading region in clinical research. Some recommendations to improve the regulatory environment include the optimization of internal processes both in pharmaceutical industries, clinical research organizations and sites, the inclusion of researchers in the regulatory processes, having different contingency plans, and opening channels of communication with the different regulatory authorities so as to know what is really going on and what can be done to improve the situation.

Another important challenge to overcome by LATAM countries is the “darkness” and distrust that surrounds the activity. Investigators should be encouraged to talk about clinical research with their colleagues at meetings of their specialties; the general public should be informed about clinical trials; and clinical research should be included in the medical carrier as an effort to end up with all the myths that surround the industry.

Conclusion

The conclusion is that there’s work to do if Latin America wants to stay in the R & D business; but if this hinge that the region is going through is successfully exploited and people understand the importance of all the stakeholders working together throughout the region, Latin America can develop all its potential on the clinical trial industry and continue to be competitive.

About the Authors:

Dr. Celso Arabetti, MD currently holds the position of Presidente at Sociedad de Investigacion Clinical de la Provincia de Buenos Aires. Dr. Arabetti has experience in Clinical Trials management from phase I to IV; particularly in developing Site and protocol budgets, Site personnel training, Feasibility studies, Investigator selection, Drug Logistic, Local and International Health authorities’ presentation, Exports and Imports, Material storage, control and logistics, EMR Implementation, Research Risk Management. Dr. Arabetti is also the Clinical Research Unit Director at the Austral University.

Valentino Jaramillo, DVM After three years as an equine veterinarian, in 2008, I transitioned to the clinical research field. I have experience in breast, colon, lung and prostate cancer as well as sarcomas. My experience includes study start up through study close outs. I always worked with multicenter studies phases II and III and outpatients. I also have teaching experience at several courses of continuing education on clinical research for investigators and study coordinators since 2009.




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