As Clinical Trials Go International, Operations Go Digital

A look back on the last few years in clinical research reveals some encouraging news: Business is booming. A 2018 study commissioned by Medrio showed an 88% worldwide increase in clinical trials between 2010 and 2017. ClinicalTrials.gov currently boasts nearly 300,000 registered studies as organizations work to bring life-saving medical products to market for populations in need.

But as is usually the case, this good news comes with caveats. While growth in clinical research is strong globally, on a regional level that growth has been lopsided, as sponsors increasingly outsource their clinical trials to up-and-coming geographies around the world. During the time period at the center of the study, Asia was far-and-away the leader in growth, with clinical trials there increasing by 188%. China and Japan had about 1,000 and 2,500 clinical trials in 2010, respectively, but both ended up near 6,000 by 2017. India remained stagnant until 2016, when it nearly tripled in just one year. A 2016 paper by Frost & Sullivan cites a variety of factors driving this growth, from regulatory favorability, to lower study costs, to the ease of recruiting patients from large populations. And last year’s publication, by China’s FDA, of a plan to eliminate hurdles that slow drug is expected to make Asia even more attractive as a clinical trial destination.

The growth of clinical trials in four different countries from 2010 to 2017.

In the West, the picture looks quite different. While there has been some substantial success in recent years-growth in the US medical device and diagnostics industries, for instance, has been strong-the West hasn’t seen nearly the level of growth that Asia has during this time frame. Compared to Asia’s growth of 188%, the study found that North America experienced only a modest increase of 12%, and that Europe actually decreased by about 2%. The outsourcing of clinical trial operations to Asia by Western sponsors and CROs has been a major factor behind these figures, and a contributor to the global, disparate nature of clinical trials today. In this new landscape, what will be the priorities of organizations looking to maximize their success moving forward?

The growth of clinical trials in North America, Europe, and Asia
From 2010 to 2017, compared to worldwide growth.

Digital transformation and a greater focus on technology

As more and more clinical trials span international borders, and the West looks to sharpen its competitive edge against up-and-coming regions in Asia, digital transformation has a major role to play. These industry trends will create new use cases for traditional and emerging clinical trial technology, and organizations will have to take these into account when planning upcoming trials. Here are just a few ways that globalization and geographic shifts are making clinical trial technology a major consideration for organizations.

· Bridging gaps for easier data sharing
With Western organizations increasingly outsourcing their operations to Asian sites, traditional data sharing only becomes more cumbersome. Coordinating on-site monitor visits and shipping paper documents becomes less pragmatic as distances increase. Up-and-coming technological resources that enable remote data sharing in real time will therefore become an increasingly useful asset. Sponsors and CROs in Switzerland monitoring data at sites in Japan, for instance, will become more reliant on technological solutions that bridge the vast geographic gaps between them.

· Ramping up patient engagement
It’s no surprise that patient recruitment, one of the most widely lamented hurdles to clinical trial success, is easier in Asia than it is in Europe and the US. Asia’s large and growing population, coupled with low government expenditure on healthcare and the resulting incentive to seek treatment through alternative avenues such as clinical trials, is conducive to recruiting larger numbers of patients faster. In response, Western clinical researchers are increasingly turning to recent and emerging technology, whether it’s electronic patient reported outcomes applications or mHealth tools that unlock remote data capture capabilities, as a means of easing the burden of clinical trial participation for patients. These tools are driving the industry-wide push for more patient engagement, and are an essential resource for remaining competitive with Asia’s patient recruitment success.

As international outsourcing continues to drive the parties contributing to clinical trials farther apart, technology will increasingly serve as a means of bringing them closer together. Whether it’s streamlining remote data sharing or strengthening incentive for Western organizations to keep their study operations local, digital transformation is defining the way clinical trials are conducted like never before-and this will only continue moving forward.

Sources

1.     Frost & Sullivan; Asia: Preferred Destination for Clinical Trials; 2016

Mike Novotny is the founder and CEO of Medrio.