Offshoring Clinical Trials
There are several strategies one can use when considering offshoring clinical trials to emerging countries. “There are challenges with each country and region,” stated Jacquie Mardell, former senior director of clinical operations at Metabolex and current director/partner at Anhvita Biopharma Consulting.
Some of the steps in choosing the right country for a clinical trial involve matching patient population and medical practice norms. For example, type 2 diabetes tends to be diagnosed early in U.S., but late in India, where there are also more complications. Ethical concerns may arise if a country requires continuation of care after study completion, which leads to budget issues. Informed consent is usually considered an individual decision in the U.S., but there are countries where is it more of a family decision.
Regulatory and ethical approval pathways are also critical. It’s important to know the study protocol will be approved by health authorities and ethical review committees in time to enroll patients before the deadline and within budget. Another consideration is broadband connection—in emerging countries studies are often restricted to bigger cities.
Some of the advantages of conducting clinical studies in these countries include drug-naive patients who are motivated to participate because of access to therapies, and investigators who want access to cutting-edge therapies and substantial costs savings. “A patient in an emerging country can cost a fraction of a patient in a Western country. Those are economic factors that can’t be overlooked by board directors and management teams trying to marshall their dollars.”
Choosing a CRO is getting easier, Mardell said, because the world market is shifting to a providers’ market. “A sponsor is eager to choose a partner because they don’t know how to do things in a foreign country and don’t have time to do all the research.” However, she noted the importance of investing time to create relationships with vendors in order to evaluate their expertise. “I think sponsors can make this choice because vendors are on their doorstep, but it takes more work to choose the right one.”
Redefining Outsourcing Strategy
Since there are no written guidelines outlining the best way to choose a CRO, companies have to develop their own strategies. “You have to define your organization in terms of what skills you want to retain and consider essential, and that only your organization can carry out,” suggested John Fry, senior director of clinical operations at Facet Biotech.
A few years ago, after making these assessments, Facet decided to outsource most of its operations. However, after reviewing this strategy, Fry said that the company decided to focus on early development—more functions are kept in house now and larger studies are outsourced.
“CROs are only as good as the team they give you,” Fry added. When going through the selection process, companies need to ascertain who the key team members are and get assurances that they are committed to the program. If there are any personnel changes, companies need to be consulted beforehand.
Fry has a specific set of criteria for choosing a CRO. “We go through a process where we start with about ten companies, reduce that down, and send an RFP out to about three. We then go through a rigorous selection process that can take several months.”