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Growth of global trials poses myriad considerations for North American PIs

Monday, July 14, 2014

The Pulse on Site Success by Jeffrey Adelglass

By conservative estimates, the global clinical research industry has experienced an 18% annual growth rate in recent years, spurred by lower labor costs, less competition and larger numbers of treatment-naïve patients in emerging markets.

Currently, over half of all trials are conducted outside the United States. The typical late stage clinical trial sponsored by small, mid-sized or large companies now is conducted in an average of 34 countries, and those trials conducted by the top 20 sponsors average more than 70 countries. 

This pattern picked up the pace from 2005 to 2009, when the number of trials conducted in non-traditional, (i.e., non-European and non-American) research countries more than doubled, from 21,653 in 2005 to 46,059 in 2009. By 2010, an impressive 78% of all participants in clinical trials were enrolled at non-U.S. sites. Among those non-U.S. patients, 58% were enrolled at sites in Western Europe, and 26% were in Central and South America. 

Locations of registered studies

Currently, we are experiencing intense globalization of clinical studies and the emergence and growth of investigative sites based in more remote regions of the world. These patterns, together with healthcare reform in the U.S., new models for delivery of trials and the changing landscape of how research sites are structured, pose myriad considerations for investigators based in North America.

I pose the reality of the global growth of clinical studies as food for thought, as we all mull over our individual concerns and next steps for the settings we represent. For example, should we truly be “threatened” by the globalization of trials, or relieved that this expansion will allow us to continue to participate in and complete trials in a more timely fashion through partnership with our international colleagues? Shall we strive to better understand how we can learn from other parts of the world related to methodology? Will these changes help us remind ourselves of the unique characteristics our culture presents?

I have engaged in discussions in which U.S.-based investigators say they do not support global growth and feel this will diminish opportunity.  I believe it is naive to be threatened by global progress, and I encourage others to embrace the inevitable. It is, however, innate within this context to realize we must continue to better our own performance to continue to compete! 

In any competitive environment, achievers understand how to leverage their abilities to meet the most pressing needs of customers. The process of growth demands professional site organizations have strategic foresight, therapeutic expertise and operational acumen that can deliver. Tactics for competition include building strong teams, and engaging those teams by putting the right individuals “on the bus” and keeping them there. 

Today’s research sites have the opportunity to define the future of clinical trials
with proactive planning and by creating an attitude of urgency to best interface with industry. Multinational trials, despite their many complexities, as well as contributions, are here to stay. Sites most likely to remain successful, regardless of where they may
be in the world, must be nimble and oriented toward process, action and solution-based thinking. 

Perhaps the next investigator meeting you attend with multinational colleagues can be approached as an opportunity for collaboration and advancement. Keep abreast of the progress of trials around the world and seek out ways to be part of a new paradigm representing a global team effort. Future trends quite possibly will require us to take a step back and evaluate the steps that led us to efforts to keep U.S. sites front and center through building more substantive outcomes and measurable goals and processes. 

Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas. Email comments and questions to jeffadel@gmail.com.

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