Attractiveness of conducting clinical trials outside the U.S.
In the last decade, the pharmaceutical industry has been expanding clinical research outside familiar territories like the U.S. and EU. Countries like Australia, China, India and Russia have become hot locations for pharma companies to conduct their research activities, and it’s no wonder why. The benefits to expanding clinical research to more countries around the globe are clear. Trials can be completed six to seven months sooner, on average, in countries like China or India, and at a fraction of the cost compared to domestic markets.
A number of governments have implemented new policies in the last few years that are intended to attract clinical research within their borders. India offers massive incentives to pharmaceutical companies, providing a 200% deduction for all in-house research and development. Like China, India also has a large patient pool for clinical testing. Although India doesn’t allow foreign companies to conduct phase I studies, the volume of potential participants allows research organizations to quickly move through their phase II and III trials, reducing cost and shortening the distance from laboratory to patient.
After years of working on improvements for clinical trials, Australia has also become a sought-after location for conducting effective, less expensive research, with a tax incentive program making clinical trials up to 60% more cost-effective. Cost is driven by a government cash rebate for research and development.
But does geographic expansion increase or reduce the risk of clinical trial failure?
Data suggests a correlation between trial success and expanding geography, particularly in emerging markets. As the number of trials continues to grow outside of the U.S. and Europe, this seems to be a promising strategy for improving trial success. But will adding new countries give you the confidence to say you’ve reduced your risk?
Look at the numbers and you’ll see geographic expansion is only one piece of the pie. An analysis of 5,000 terminated trials showed 30% of phase III study terminations are due to enrollment difficulties, making patient recruitment the leading cause of trial failure.
Given that nearly 80% of clinical trials fail to meet enrollment timelines, it is clear the challenge has less to do with patient availability in a given region than with our ability to accurately forecast what will be required to enroll them.
In a global survey of investigators, 90% of Chinese investigators indicated recruitment is challenging in their country and 80% say communication with subjects and retention during the course of a trial is challenging. All of them expressed interest in using digital media for identifying prospective patients and acquiring patients into trials. Fortunately, Chinese law does not prohibit online recruitment of patients for clinical trials. Indeed, there are already some websites in China that publish ads for clinical trials. China represents an excellent opportunity to leverage social and digital tactics to help investigators recruit and retain subjects.
As companies continue to grow and test in other countries, they should be wise to the limitations of some de facto standards used in developed countries. In a multi-cultural context, some of these practices don’t work as well—or at all—in emerging markets.
Gathering informed consent using conventional, paper-based systems, for instance, is almost entirely of no use in countries with low literacy rates and a minimal understanding of modern medicine. Imagine volunteers who can’t read or write, with no access to basic healthcare and who have very different ideas about health and disease. How are they supposed to comprehend pages they can’t read? How are they supposed to sign the forms? How tempted might they be to join the trial thinking it was their only way of receiving medical treatment they desperately need?
With the growth in global clinical trials outside U.S., our approach to informed consent should be reconsidered. Dr. Falguni Sen, director of the Global Healthcare Innovation Management Center at Fordham University who has studied the challenges of conducting clinical trials in India, explains that a poor, maybe illiterate, population with a blind faith in doctors, having no other recourse to treatment, cannot really assess risk and benefits and rationally volunteer for a trial.
There are many benefits that come with moving clinical studies to countries outside the U.S., including untapped populations, faster recruitment and lower costs. The symbiotic relationship between foreign governments and the pharmaceutical industry helps support this expansion. But it’s not an apples to apples comparison between trials conducted in the U.S. and trials conducted abroad. Research organizations should know what they’re getting into beforehand in order to capitalize on the benefits.
Matthew Howes is executive vice president, Strategy & Growth for PALIO, an inVentiv Health company. A leader in digital strategy, he has provided the fuel for digital businesses visited by more than 100 million people every month. Email firstname.lastname@example.org.
This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »