Sponsors must consider the challenges as well as advantages when moving trials to emerging markets
As drug sponsors increasingly look to emerging markets for greater patient access and lower trial costs, they must also consider the potential disadvantages of moving operations to a developing country when choosing the best location for a clinical trial, according to new research from Cutting Edge Information.
Even though clinical development executives ranked India as the emerging market with the greatest patient availability, at the same time they said investigational drugs developed in India are at higher risk for being copied because of weak intellectual property laws. And while survey results showed that clinical trial costs were lowest in Asia, respondents also reported that Asian culture can be difficult to navigate due to the numerous languages and traditions in the region.
“Questions of quality, different regulatory frameworks, intellectual property laws and cost structures can be incredibly complex for clinical development teams working globally,” said Eric Bolesh, director of research at Cutting Edge Information. “You need to understand the advantages and challenges before choosing a particular location for a particular study.”
In a new series of five reports, called the Emerging Markets Clinical Development Series, Cutting Edge Information examined the strategic advantages and disadvantages of running clinical trials in 24 emerging clinical markets, including Brazil, Russia, India, China, Africa, Mexico, Eastern Europe, Southeast Asia and South America. The research was based on survey results and interviews with leading clinical executives from pharmaceutical, biotechnology and medical device companies, along with executives from both regional and global contract research organizations (CROs).
Drug sponsors are moving toward emerging markets to do their clinical development, according to the study, mainly to recruit the most patients at the lowest possible cost. In terms of cost savings, the research found that across the board, most regions offer at least 11 percent to 25 percent savings compared to studies conducted in the United States or Western Europe for the majority of drug sponsors working in emerging countries. Notable exceptions were Asia, where half the survey respondents saved up to 50 percent on clinical trial costs, and Africa, where clinical teams reported only 6 percent to 10 percent savings.
Survey respondents also reported a high rate of satisfaction with access to patients and patient retention rates in all emerging regions. India was ranked as the market with the greatest patient availability, followed closely by China. For patient retention, China—which has the largest population of any country—took the top spot, followed by India. The survey found lower patient drop-out rates in emerging countries compared to those in developed nations. One respondent reported retention rates above 90 percent for a trial in Russia; the same study in Germany had a 40 percent retention rate.
Overall, the survey found the benefits outweigh the challenges of entering emerging markets. Yet clinical development executives do have concerns about moving their trials into these countries.
The top concern is the regulatory environment, including how long it takes to attain the approvals required to begin a trial. Africa ranked the highest among respondents for positive regulatory experiences, while Latin America and BRIC (Brazil, Russian, India and China) countries rated the lowest. Respondents said regulations are often confusing in developing countries and it can be difficult to clarify the requirements or determine why there are delays in the process.
Another top concern is intellectual property (IP) protection. Executives indicated they had the best experiences with the IP environment in Africa and the worst experiences in Asia and the BRIC countries.
Executives also are concerned about whether the regulatory agencies in the U.S. and Europe will accept data from clinical trials conducted in emerging countries. However, most respondents are pleased with the quality of the data they have received from trials in emerging markets. “In general, the message we got was that concerns about quality should not keep companies from operating in any one country or region,” Bolesh said. “Major issues affecting regulatory bodies accepting data are few and far between.”