(Jon Han) 

Building Clinical Trials with BRICs

Emerging markets—particularly those of Brazil, Russia, India and China—offer multifaceted opportunities for life science companies, including new upstream innovation through a diverse pool of international talent, as well as access to an ever-expanding commercial landscape for existing and new products. A key driver of growth in these regions is the opportunity for biotechnology and pharmaceutical companies to expand their clinical trial portfolios. In a recently published report, Emerging Markets Clinical Trials: BRIC Countries, Cutting Edge Information (CEI), a Durham, North Carolina–based business intelligence firm, elucidates some of the challenges and benefits of running trials in BRIC nations.

Culled from surveys of individuals working in these countries, the report offers an on-the-ground picture of the dynamic environment of clinical trials in the BRICs. Although working in these nations presents benefits for clinical operations, making a successful transition requires knowledge and expertise. The CEI report makes clear that some aspects of running trials in the BRICs prove easier than others.

The Attraction

As the CEI report notes, the BRICs lured in life science firms from other countries well before the recent economic challenges and the looming patent cliff were in view. Given these added incentives for stimulating growth, the attraction to BRIC nations should be even stronger.

Much of the appeal of conducting clinical trials in the BRICs comes simply from the numbers. As the executive summary of the CEI report states: “To help combat the patient enrollment problems, many companies have turned to the emerging markets and to the BRICs markets in particular. Brazil, Russia, India and China offer access to nearly 3 billion patients, a number much higher than the 600 million located in the U.S. and 5 EU countries (United Kingdom, Germany, France, Italy and Spain). Even more importantly, most of BRIC’s 3 billion patients have not participated in clinical trials in the past or even been treated for their indications, making BRIC countries the holy grail for pharmaceutical companies seeking treatment-naïve patients.”

While the size of their populations make the BRICs attractive for clinical trials, the CEI report points out that some of their low numbers are appealing as well. Specifically, the low number of ongoing clinical trials in the BRICs could simplify enrollment in these countries. As of September 3, 2010, for instance, the CEI report indicates that ClinicalTrials.gov included 49,449 trials registered in the U.S., but only 1,898, 1,463, 1,389 and 1,745 for Brazil, Russia, India and China, respectively. So for the BRICs combined, that adds up to 6,495 trials—only about 13 percent of those in the U.S.

Patient Appeal

To develop effective and efficient clinical trials in the BRIC nations, companies need access to patients who enroll in the studies and complete them. CEI asked experts to rate access to patients in BRIC countries on a 1–10 scale, with 10 being the best. (The same scale is used for other CEI data presented here.) On average, experts rated India the highest and Brazil the lowest, while the combined BRIC average of 8.2 suggests good patient access overall. Nonetheless, the CEI report points out that “some respondents ranked China and Brazil at 4 and 5 out of 10, respectively, reflecting negative recruitment experiences.”

Patient retention rated slightly lower than access on average. When it came to keeping patients in trials, the experts told CEI that China and Brazil are the best and worst, respectively.

Riding the Rules

Finding billions of potential patients in the BRIC nations does not solve every clinical development challenge. Anyone involved in the biotechnology or pharmaceutical industries is aware of the concerns about their regulatory and intellectual property (IP) environments.

CEI reports 4.9 out of 10 as the average rating of the regulatory environment across all of the BRICs. For each country, however, this report found a wide range of ratings, including 1–9 for Brazil and 2–10 for India. Clearly, different experts relayed very different experiences. For IP laws and practice, the CEI report found somewhat higher ratings—an average of 5.4 across all BRICs and experts. Like the regulatory ratings, however, the ranges stretched so far that they preclude a general conclusion about any of the BRICs.

For the respondents who gave high scores to regulatory environment and IP, CEI suggests that “successful companies utilized local experts familiar with the guidelines and challenges and, perhaps most important, the regulators themselves.” In short, working with regulatory and IP issues in the BRICs is not for the uninitiated.

The merits of conducting clinical trials in these regions also depend on a firm’s overall goal. For example, just because a company wants to run trials in a BRIC nation, doesn’t mean that it wants to sell a product there. The CEI report notes how “one interviewee stated that while his company prefers to run clinical trials in India, the brand will rarely be launched there due to copies already in existence. In essence, his company considers India as a lost marketing cause but as a valuable site for clinical development.”

Days and Dollars

Despite the challenges, companies can save time and money by running clinical trials in the BRICs. CEI found that on average, 13 percent of respondents conducting trials in these nations said they saved 51–75 percent in costs. Just under 40 percent reported saving 26–50 percent, while 43 percent said they saved 11–25 percent. But not all respondents saved money, as 4 percent said that BRIC trials cost them more.

When it comes to the amount of time needed to run a clinical trial in the BRICs, only 4 percent of the respondents in the CEI report claimed a time savings of 51–75 percent. About a quarter said they saved 26–50 percent, and 30 percent reported a time savings of less than 25 percent. Nearly 40 percent, though, said that BRIC trials took longer. In fact, 67 and 75 percent said trials in China and Brazil, respectively, were more time consuming.

The CEI report states: “Misunderstanding regulations causes the highest increase in time expenditures, according to several interviewees, because each time the sponsor misses a deadline, provides the wrong information or does not provide enough information, the regulatory clock resets.”

Just as the regulatory and IP environment data demonstrated, saving time and money in these regions also depends on experience.