The Joys and Woes of Clinical Trial Startup | Page 7

Within these urban areas, qualified sites tend to be large hospitals that serve significantly
more patients than the average US site.15 In some countries, such as China, India, and
Brazil, rapid enrollment can often offset slower regulatory and ethics approval timelines.
However, a large patient population is only part of the solution. Patients also need
to be appropriate for the study and willing to participate. Disease prevalence
often varies by country or region. For example, in Peru, genetic differences lead to
unusually high rates of both gastric and gallbladder cancer.4,22 In addition, with the
ever-growing influence of US culture, the rates of typically Western diseases (eg,

Did you know?
Concentrated populations
in Russia and Eastern
Europe often lead to
enrollment rates that
are up to 20 times faster
than in the US or Western
Europe.21

obesity, heart disease, cancer) are increasing rapidly in other parts of the world.2,4
Patients in Asia and Latin America are more likely than their Western counterparts
to follow a physician’s advice to enroll in a trial.15,22 There is also evidence that
populations in these regions have higher rates of treatment compliance and lower
rates of study withdrawal.15,22

Site Selection »
Investigator Qualifications
With one-third of the phase III trials for the 20 largest US pharmaceutical companies
being conducted solely outside of the US,3 the qualifications of international
investigators are critical. Fortunately, most are well-educated, experienced with
clinical research, and have the knowledge and resources to adhere to ICH-GCP.3,18
For example:
•  ussia, which has more doctors per capita than any other country,13 has federal
R
regulations requiring the primary investigator at each site to have at least 5
years of clinical trial experience.12
•  n Latin America, site inspections have found that investigators consistently met
I
all FDA standards for collecting clinical trial data4, and, as a result, the number
of phase II trials conducted in this region has increased significantly in the last
decade. Now phase I trials, which require considerable investigative experience,
have begun in some Latin American countries.
»» NMAT, the Argentinian regulatory agency, has been a regional pioneer in
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