Emerging Markets Clinical Trials: Latin America (PH146)

Brazil, Argentina, Mexico and Other Emerging Latin American Countries

&nsbp;

CLICK TO DOWNLOAD
Published 2010
189 Pages
400+ Metrics
100+ Charts and Diagrams

Overview Metrics Excerpts

Improve Trial Outcomes with Latin American Operations
As R&D costs rise exponentially and trial subjects grow scarce in the US and Europe, life sciences firms are turning to the emerging markets to supplement patient enrollment — and to reduce costs.
Latin America holds about 1/10 of the number of trials of the United States, and Brazil, numbered among the high-profile BRIC market, receives the lion's share of attention. But savvy companies leverage other nations' untapped promise: patient availability, advanced knowledge and infrastructure, and ease of communication. These advantages are cultivated in an environment open to clinical development, but scores of questions can create reams of data - and misperceptions - and potentially keep teams away.
Eliminate information clutter and zero in on the key clinical research in emerging markets of Latin America. Access primers on individual countries that include time- and cost savings benchmarks and rankings data while learning from others' first-hand experiences to reap the benefits of the region:
Pick the Right Market
Compare costs, timelines, regulatory environments and problem areas across countries as you discover unique benefits to each. Explore ratings for 13 elements of trial success.
Accelerate Patient Recruitment and Retention
Target markets for treatment-naive patients, and discover the factors to ensure easy recruitment and strong retention.
Navigate Tricky Issues
How do companies protect IP? How do they manage longer setup times and overcome regulatory hurdles? Discover which governments protect IP and find real-company best practices for managing different regulatory guidelines.
Master Trial Management
Balance reliance on local expertise with trial oversight to build strong partnerships. Uncover fresh strategies to prepare your teams for the challenges that will inevitably flare up.
Back to Top
Back to Top
Clinical Trials Latin America Metrics
Executive Summary
- Average percentage of budget saved by running a clinical trials in Latin America site
- Average percentage of time saved by running a site in Latin America
- Population comparisons between Latin American nations, the United States and Europe
- Number of registered studies across profiled Latin American countries
- Rankings from surveyed companies of benefits and challenges:
The four chapters in Emerging Markets Clinical Development Series: Latin America use primary and secondary information to provide comprehensive overviews of the clinical development environment in Latin America's emerging markets:
Section 1: Clinical Development Overview
- Key demographics (population/ethnic breakdowns, life expectancy statistics)
- Key economic figures (GDP, labor force, distribution of family income)
- Disease prevalence
- Politics
- Healthcare system
- Pharmaceutical market (overall picture of market, leading local companies)
Section 2: Clinical Development Environment
- Percentage of budget saved by running a trial in this location
- Percentage of time saved by running a trial in this location
- Assigning clinical development responsibilities
Clinical Trial Environment Scores and Trial Operations Scores
Environment
- Available knowledge base
- Regulatory environment
- Intellectual property laws and practices
- Communication/language
- Culture
- Anticipated cost
Operations
- Access to patients
- Patient retention rates
- Investigator standards
- Data standards
- Site management standards
- Trial technology infrastructure
- Supply chain management
Section 3: Individual Company Profiles
This report contains a total of 12 company profiles that contain the following components:
Company Background
- Company mindset and key clinical feasibility factors
- Factors that impact clinical environment
Clinical Environment Assessment:
- Regulatory environment
- Available knowledge base
- Intellectual property laws/practice
- Communication/language
- Cultural concerns
- Anticipated cost
Trial Operations Assessment:
- Access to patients
- Patient retention rate
- Investigator standards
- Site management standards
- Data standards
- Trial technology infrastructure
- Supply chain management
Experience in Region
Activity in Region: Maps the geographic scope of the company's clinical operations within the region.
Experience Specific to Country: Provides information on the company's operations within the country, including year of entry, method of entry and current level of presence within the country.
Clinical Strategy in Country
Responsibility breakdown shows each company's clinical operations assignments among four groups - corporate team outside country, corporate team inside country, multinational CRO, and local CRO/vendor. The data detail 12 clinical responsibilities:
- Protocol development
- Site selection
- Investigator training
- Patient recruitment
- Site monitoring
- Investigator management
- Data collection
- Data management
- Data cleaning/analysis
- Medical writing
- Regulatory agency communication
- Health economics consideration
Clinical Environment and Trial Operations Scores
Shows a company's score for each of the clinical environment and trial operations factors listed above.
Back to Top
Clinical Trials Latin America Report Sample
This excerpt focuses on aspects of the country's disease burden. The full chapter presents a detailed picture of Mexico's demographics, economy, politics and healthcare. Charts illustrate important data points.
Disease Prevalence
Diabetes is the number one cause of death in Mexico, followed closely by ischaemic heart disease (shown in Table 3.2, which appears in the accompanying summary). The two causes account for nearly 25% of all deaths in Mexico; after these diseases, incidence rates drop significantly.
Several factors, including increasing obesity, along with access to care and patient monitoring, underlie the growing number of Mexicans with diabetes. (In fact, Mexico ranks second only to the United States in the prevalence of obesity among the 28 OECD member nations.) More than 75,000 people died from diabetes or related complications in 2008, and that number is expected to rise to above 100,000 by 2012. Secretary of Health Jose Angel Cordova Villalobos has predicted that by then, as much as 40% of the Mexican population will suffer from diabetes.
To combat the disease, Villalobos launched a coordinated government action plan in 2008 with the goal of reducing the incidence of the disease and improving the monitoring and treatment of diabetes patients.
As for the other causes of death in Mexico's top 10, various forms of cancer occur less frequently in Mexico than in similar Latin American nations and significantly less frequently than in the US. Notably, homicide made the top 10 list with a rate of 2.6%. Latin American countries account for 12 of the 15 countries worldwide with the highest incidences of homicide. In Mexico, this is largely attributable to narcotrafficking violence perpetrated by powerful drug cartels.

The following segment is excerpted from Chapter 2, "Argentina," Section 2, "Clinical Development Strategy." The full report outlines executives' best practices for running trials in Latin American countries. Complementing their insights are benchmarking data and rankings for 13 factors influencing a trial's success. Regulatory environment is one of these factors.
Regulatory Environment
While clinical trials in Argentina are cheaper than trials in the US, survey data show that running trials in Argentina ends up being more time-consuming. This is likely due to Argentina's very slow-moving regulatory environment.
As ANMAT is able to decrease regulatory timelines required for pharmaceutical companies to move forward, it should become less of a problem. As one interviewee noted, the problem stems from the age-old law of supply and demand: agencies need to increase their resources to deal with the many submissions before regulatory timelines can shorten.
A consultant from a large pharma company, however, said that the time spent waiting for regulatory approval was not worth the wait, and the company ended up cutting its losses in 2008 and pulling out of the country before the trial could begin. This interviewee discussed the confusion and frustration revolving around the complicated regulatory process by stating: "Contact with the regulatory authority agency is not very easy. It is difficult to understand why [the approval process] takes so long. And in the case of no approval, it is not easy to obtain more information, to change the protocol, or to provide an amendment." Since communication and access with the agency was so difficult, ultimately, the interviewee did not move forward with the trial.
Since sponsors must meet both national and provincial regulations, it is easy to become lost in the different processes and regulations required - and any missed step only further complicates the process. Therefore, as another interviewee stated, "The first challenge is to harmonize the regulations between the nation and state regulations." Regulatory approval can be a complex and time-intensive process, especially depending on whether the national or state regulation application process is submitted first. Drawing on experience, one executive recommended submitting to the state before submitting to the nation, as the nation's application could then draw from the completed state application.
Back to Top