Until fairly recently, clinical trials were something which took place in basically a handful of locations around the world – wealthy communities in North America, Europe, and Oceania (Australia and New Zealand).
That is changing, however, as is the general landscape of the clinical trials environment.
Trials in general are becoming increasingly complicated and take more effort to manage – a situation prompting drug makers to seek help from external resources. Meanwhile, the pressure is on to develop better-performing drugs which cost less.
Currently, the U.S. National Institutes of Health reports 231,860 studies ongoing, with locations in all 50 states and 194 countries. More than a third are in the United States, but beyond that currently clinical trials locations are spread fairly evenly.
“Asia has become a prominent location for clinical trials,” according to one report. Trials were formerly conducted in Asia, but efforts were primarily for cost-cutting reasons. Now, the market is seeing Asian pharma companies testing on their home turf. “Increasing numbers of global drug companies thus include those key emerging countries in the region into their late phase, multi-site global trials with aims to launch their products in these markets at the same time as in the developed markets,” the report added.
In addition to Asia, clinical trials are being held increasingly in Eastern Europe and Latin America.
“Reasons cited for this shift include the ability to reduce operational costs while recruiting a large number of patients in a timely manner,” noted an MIT analysis.
MIT found that 62% of early trials were being held in North America, while confirmatory trials were higher in Eastern Europe, Latin America, and Asia. Post-marketing trials moved back to Western Europe.
“In terms of growth rates, 24 of the fastest growing 25 countries are from emerging regions, while 19 of the 25 slowest growing top 50 countries are from traditional regions,” MIT reported.
The U.S. National Institutes of Health reports that European trials were most common in France, Germany, and the U.K. and least common Albania, Montenegro, and Luxembourg.
Across Asia, trials are scattered. There are nearly 9,000 in China but just 14 in Mongolia and 1 in North Korea. Numbers are similarly mixed in Africa – there are 2,247 in South Africa and 1,320 in Egypt, but there are scores of countries with less than 20 trials ongoing and two with none (Eritrea and Somalia). Other leaders around the world include Brazil (5,346), Israel (5,932), Australia (5,418), and Thailand (2,030).
The globalization of clinical trials has benefits and drawbacks.
“Potential benefits include diffusion of medical knowledge and effective medical practice, and great patient access to high quality medical care,” MIT found. But drawbacks included: inadequate regulatory oversight, difficulty of drawing valid conclusions from diverse populations, ethical issues such as the integrity of informed consent, and more.
Despite the trends, North America, Europe, and Oceania will still dominate the research environment. Developed countries will continue to have large facilities, global capacity, trained investigators, effective recruiting tools, and a base of patients to draw from.
In the United States, trial density closely follows population density: Texas, New York, and California have the most ongoing trials, followed by Florida, Ohio, Pennsylvania, Massachusetts, Illinois, and North Carolina. States with the fewest trials included Wyoming, Alaska, South Dakota, Montana, North Dakota, and Maine.
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