Brazil is one of only two Latin American countries (besides Argentina) to have its own contract research organization (CRO) association, and one of only a handful of countries on Earth to do so. That alone speaks volumes about the maturity and size of its clinical research market.
Launched in 2006, the Brazilian association is called Associação Brasileira de CROs (or “Abracro”) and naturally most of its energy has been focused on simplifying the country’s labyrinthian regulatory environment.
Last year and this year, Abracro and other stakeholders in the industry worked with the government to try to change the clunky approvals process, lest Brazil’s slow start-up times hobble the clinical research market that has grown robustly there over the past 12 years.
In the summer, victory. Agência Nacional de Vigilância Sanitária (known as Anvisa), the Brazilian FDA, agreed to let sponsors and CROs seek various approvals simultaneously instead of sequentially. When that change takes full effect, it should lop several weeks off the time it takes to start a trial in Brazil.
Vitor Harada, the association’s president, also serves as director of clinical operations in Brazil for Icon Clinical Research. He says an attempt to end the double ethics board approvals process is the next item on the Abacro agenda.
In Brazil, Harada explains, a sponsor or CRO wishing to start a trial must first get ethics approval from local ethics committees near the investigator sites, and later do the same from the Conselho Nacional de Saude (known as Conep), the national ethics committee. This, he says, is redundant.
Safe and Logical
“Conep was initially created to regulate the system, to guide and control the [local] ethics committees and be a higher [entity] to solve disputes,” he says. Instead, it morphed into a body that requires another layer of approval unto itselfl. That has put a damper on trial starts.
“We have good momentum now, and we’re trying to capitalize on that, and be more competitive,” says Harada of Brazil’s clinical trials industry. “It doesn’t seem that people at Conep see this as a global process. Their main concern is protecting the patient. We say they can do both. We don’t want a system that approves everything, just one that is logical. Sometimes things are not logical in Latin America.”
Best case scenario? Together with the Brazilian Society of Pharmaceutical Medicine and the Brazilian Association of Clinical Research (which represents sites and investigators), Abracro is proposing “that the country adopts only one step of ethical evaluation of clinical studies, as is done in almost all countries in the world,” says Harada.
Leaving The Fold
PPD, the largest CRO in the market, with 300 employees in Brazil, was formerly a member but declined to say why that is not the case today.
A push is on to get the country’s many small CROs interested in joining Abracro. Membership would give them, perhaps more than the big and medium-sized CRO members, much needed support in tough situations, says Harada.
“If a single CRO protests against a situation too strongly, they could be afraid of being remembered as a difficult company, while Abracro, and not the way it was meant to be would not get any potential retaliation,” says Harada of CROs’ interactions with sites, sponsors and the government.
Abracro has three committees—regulatory, contracts, and suppliers. Of course, the regulatory committee gets the most action, meeting once a month. The other two meet when needed.
The contracts committee focuses on agreements between CROs and investigator sites. As in the rest of the world, Harada says, site contracts tend to be a significant bottleneck for new trials. The aim is to work on best practices for streamlining communications back and forth on those contracts in an effort to reduce start-up times even more.
And the aim of Abracro’s suppliers committee is to get its members better leverage when it comes to pricing from vendors like, say, translation companies and travel agencies. Harada says he hopes this service helps bring in small CROs that must keep costs very low and which, on their own, have very little leverage in negotiating.
The cost of Abracro membership is $400 per month, no matter the size of the CRO. Part of those funds go toward the association’s scholarship program. Three years ago, it partnered with the medical school Faculdade De Ciencias Médicas da Santa Casa de São Paulo to create a post-graduation program in clinical research. The students do internships with Abracro members, and, upon graduation, are considered for jobs there.
Abracro is in the midst of relaunching its website to make it more of a portal for members, including message boards and minute meetings. Harada says the organization also wants it to be a reference guide for anyone hoping to conduct trials in Brazil. The new site will be in English, Portuguese and Spanish.
The organization currently has only one employee, a secretary in Sao Paulo. Most of the work is done by volunteers who, like Harada, are employed by one of the CRO member companies.
Harada says he hopes that as the regulatory system gets more “logical,” and thus friendly to industry, that more CROs will put down roots in Brazil, and band together as Abracro members to make Brazil the best emerging market for trials on the map.
—by Suz Redfearn
Editor’s note: This article is the third in a series. The first article was an overview of the clinical trial landscape in Brazil; the second story discussed recent regulatory changes; the final installment profiles a large and small CRO operating in the country.d9A2t49mkex