The clinical research market in South America

The South American clinical research market is complex in nature due to different regulatory frameworks and varying timelines to register, and receive approval. Several factors favour clinical trial in South America. Population diversity across the continent for patient recruitment and  population concentration in major cities of SA provides good dynamics for patient both recruitment and retention. This is supported by low manufacturing costs and facilities that are increasingly compliant with Good Manufacturing Practice (GMP) standards providing solid base for exports.

Brazil and Argentina are two of the most attractive markets for conducting clinical studies. Both countries have a good patient pool across different therapeutic areas, such as oncology. The countries also score well on infrastructure and regulatory parameters. They also provide a universal health care system with hospitals to support clinical research and rules to ensure adherence to ethical review standards.

Clinical research organizations
Global Clinical Research Organizations (CROs) like Covance, PPD, Quintiles, Parexel, Med pace, Kendle, ICON, RPS, Pharm net/i3, Research Point have operations in South America and can provide one-stop-shop services across the region. Most of the global CROs have partnerships with hospitals/universities in SA and provide majorly Clinical Monitoring, and technology development services to drug companies for regional and global clinical trials.

Local CROs do not have strong operations across SA and their capability to provide one-stop services is minimal compared to global CROs but due to better understanding about local regulation they can do the clinical trial faster and at lower cost. Local CROs are better equipped to tackle cultural barriers due to different languages, ethnic groups and races. Some of the local CROs with good presence in SA are Mmatiss, South Cone alliance, Eurotrials, Intrails.

Research opportunities
Seasonal Studies: In SA, the timing for regulatory submission for winter seasonal studies in the northern hemisphere starts in September/October so that approval can be secured by March/April. The region is an ideal contingency plan for seasonal studies because the number of initiated sites can be determined by enrolment success.

Vaccines: The success rate of patient enrolment vaccination in clinical trials in LA depends mainly on the local calendar. To maximize patient enrolment pharma companies could follow this national calendar.

Metabolic Syndrome (obesity, hypertension, IGT): Metabolic syndrome is most prevalent in Mexico City (27%) and Barquisimeto (26%), followed by Santiago (21%), Bogota (20%), Lima (18%), Buenos Aires (17%), and Quito (14%).

Hepatitis C: Brazilian hepatitis market is estimated at $120 million. In 2008, sales of hepatitis C drugs in Brazil accounted to 16% of the US hepatitis C drug market by sales. China and India accounted for less than 10% each of the USA market. Brazil’s larger market size is partially attributed to government subsidies for eligible patients. Certain regions have higher concentrations of genotype 1 and 2 patients. (Décision Ressources Dec ember 2009)

Type 2 Diabetes: In the age group of 30 to 69 estimated prevalence rate of type 2 diabetes in Mexico City, Argentina was 14.9% in 2009. For Sao Paulo, Brazil , the estimated rate is 12% for the same period.

Influenza: In June 2009, a Buenos Aires lab tested 513 patients of which 54% were positive for H1N1. (EID Vol. 16 Feb 2010)

Asthma: In Brazil, asthma was the third cause for hospitalization in 2011 for children and fourth for adults. (DATASUS-government database – A Study in 2009)

Renal Disorders: People across LA have high risk factors for renal disorders providing research opportunities for dialysis, transplant, CKD, and ESRD.

Regulatory challenges for clinical trials submission
Local regulatory framework is the  main barrier to enter the clinical trials market in SA. Trade-Related Aspects of Intellectual Property Rights(TRIPS) issue, variation of qualitative data from one country to other, confidentiality of data, need of local experts and complexity in regulatory framework due to different timelines to register and approval make SA less attractive for big pharma companies.

There are many local areas within all South America countries where the regulatory submissions criteria are still in transition.

• Each country within South America has its own set of regulations
• Sponsors have to go through periodical reviews by the regulatory authorities
• The informed consent form must be in local language

Countries such as Brazil have seen the need to shorten approval cycles and have worked diligently to process approvals to better serve the needs of pharmaceutical companies shorten regulatory timelines.

Clinical trial submission strategies
Submit Regulatory Documents Early – While longer regulatory timelines are offset by faster enrolment, it is important to avoid delays. Perform translations for regulatory documents in advance, have customs documents reviewed by local expert, and obtain site agreements prior to approval are ways to avoid such delays.

Ethics Considerations – Expenses to patients should be proportional to local income, consider post-study treatment plan for patients, avoid placebo design, and have the rationale clearly communicated.

Informed Consent Form – Perceived difficulty for patients to understand the language of an ICF agreement is a common reason for regulatory delay. The language should be plain and direct than typical ICFs of the US. Lack of protocol information in ICF is another cause for delay.

Shipping and Customs – While investigator fees and treatment costs are lower in LA, costs for shipping and import duties can be significantly higher. Local purchase of supplies and avoiding delays by working with an experienced local partner would reduce cost to a greater extend.

Country Specific Plans – Each country’s laws and customs demands a specific plan for conducting ideal studies. Although most countries speak Spanish, LA countries have subtle linguistic differences that can result in miscommunications if they are not properly addressed. Local insurance requirements also may vary.