High costs and recruitment issues drive the globalization of clinical trials
The pursuit of global trials is increasing. A report by SCORR Marketing and Applied Clinical Trials examined the reasons why companies are pursuing global clinical trials and the challenges they face in conducting them. The top two reasons cited in the survey for trials exiting the U.S. and Western Europe and moving to other regions were high costs and patient recruitment difficulty.
“Sponsors and CROs are looking for ways to make clinical trials better, more efficient, cheaper and faster,” said Howard Wong, market analyst at SCORR Marketing. Survey interviewees believed that India, Russia/Eastern Europe, China and Latin America were the most affordable countries for clinical trials.
Experts interviewed by CenterWatch agree that cost is a primary concern, but some question whether the actual costs of trials will decrease through offshoring. “In theory, the ability to execute trials in these other regions can substantially lower the cost of conducting a study,” said David Blume, managing director of Edgemont Capital.
He noted that China and India have both experienced problems with data integrity. “If there are data issues with the study, the cost can be exponentially greater than conducting studies in the U.S. or Western Europe. It is incredibly costly to redo a large study, particularly multi-year studies.” Blume pointed out that other regions may be more attractive with respect to data integrity. “Russia and Eastern Europe are lower cost regions that tend to produce reliable data.”
Other issues can also alter the cost equation. “Initially, expansion into emerging countries was driven by the belief that per-subject costs might be lower overall,” noted Jill Johnston, president of the WIRB-Copernicus Clinical Service Organization. “However, once the fully burdened cost is calculated, including getting study supplies, clinical supplies and centralized laboratory kits and samples in and out of these more remote locations, the total overall costs per subject in these emerging countries can be quite high.”
Sara McKenzie, principal consultant at PharmaDirections, also highlighted cost, noting that the Australian government offers an R&D incentive program for clinical trials that provides a 40 to 45% refundable tax offset for eligible companies. “The Australian government is trying to draw that business in,” said McKenzie.
Patient recruitment is the second major driver cited in the SCORR/ACT report. Recruitment can be easier in emerging markets for several reasons, including fewer regulations and the availability of treatment-naïve populations.
Blume noted, “Patient recruitment is consistently one of the top three challenges sponsors face conducting clinical trials, particularly in certain therapeutic areas such as oncology where it is challenging to find naïve patient populations.”
McKenzie cited lack of access to modern medications and healthcare as a factor. “In Eastern Europe, patients are willing to participate because they don’t have the same level of medical care that we have in the U.S.,” said McKenzie. “Here, people have a lot more options and are more risk-averse.” Further, “Everything is globalizing. People are going to where the patients are.”
While globalization is trending, outcomes aren’t all positive. Interviewed experts highlighted problems companies encountered when shifting trials to developing markets. “By expanding their reach into emerging countries, sponsors believed that the study teams would encounter less competition for clinical trials at the various sites; investigators would be eager to find new treatments for their patients; and there would be more resources to focus on enrolling subjects for their trials,” said Johnston. “The flip side to this can be fewer GCP/ICH trained sites, broader interpretations of the clinical trial regulations, less experienced staff, possibly lower quality data and a lack of formally trained clinical monitors.”
McKenzie emphasized potential downsides to off-shoring. “Data integrity is a major concern,” said McKenzie. “So are the challenges of managing across time zones, language barriers and even lack of experience on the part of investigators.” McKenzie pointed to longer start times in some countries. “It can be much less efficient if you go offshore,” she said. “It’s definitely a mixed bag if you go ex-U.S.”
McKenzie noted a trend among her own clients, which are exclusively very small companies. “Almost half my client base is considering or moving trials to Eastern Europe and Australia. Smaller companies feel a lot more pressure on their timelines,” she said.
Wong believes China holds promise for companies seeking to offshore clinical trials. “The number of newly registered clinical trials in China and data from this and previous surveys indicate China will be important for global clinical trials,” said Wong. “They have a large patient pool, and a lot of large cities and hospitals, which will facilitate patient recruitment. They are working on training or increasing the number of qualified clinicians.”
For all that globalization is on the rise, is there still room for U.S. and Western European trials? More than likely. “I think this is a cyclical industry phenomenon,” said Blume. He noted that certain types of trials may be kept in the U.S. and Western Europe. “Studies that have more complex protocols are less likely to be offshored. Lower revenue per subject studies generally are more likely to be conducted in less expensive geographies because they are easier to execute.”
According to Johnston, “Between the mid-2000s and the early-2010s, many organizations [big pharma and large biotechs] were looking to significantly expand their phase II-III clinical trials more broadly into emerging geographies, yet still maintain a solid foothold in traditional countries. In 2013, we started to see companies who had been early adopters of the emerging country model start shifting back toward including more sites in traditional countries.”
Johnston continued, “I believe there will always be a core set of sites in traditional countries, but it is beneficial to expand into emerging countries where and when it makes sense. I do not believe the number of sites in emerging countries will necessarily increase. It will remain pretty stable, increasing and decreasing based on the prevalent therapeutic areas and clinical indications, in addition to regulatory or marketing considerations, that require a global market.”
This article was reprinted from Volume 21, Issue 33, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »