Clinical research looks much different today than it did just a few years ago. Whether it’s new approaches to clinical trial design, a surge in eClinical technology, or recent medical breakthroughs, the industry is under the influence of a wide array of forces driving its evolution.
For CROs, some of the greatest impact has come from two related trends: the globalization of operations and the rise of outsourcing. The former of these owes to numerous factors, whether economical, logistical, or stemming from the current worldwide public health landscape. Regions like India and the Asia Pacific (APAC), with their vast patient populations and lower clinical trial costs, have unleashed a frenzy of clinical trial activity, with many organizations – even those based in Western countries, running trials at sites in China, Japan, and elsewhere. A recent concurrence of infectious disease outbreaks, whether Ebola in West Africa, Zika or Chagas in Latin America, or HIV in South Africa, have also contributed to the globalization of clinical research. As eligible patients for trials of treatments for these diseases reside largely or almost exclusively in the regions where these outbreaks have taken place, clinical trials have crossed oceans and continents to set up sites in those regions.
All of this comes as sponsors increasingly outsource their clinical trial operations to CROs in search of greater cost efficiency. Industry research shows that the share of CRO-managed trials as a percentage of the total number of trials increased eight percent between 2013 and 2017. This growth is expected to continue, increasing competition for sponsor business – and placing a higher premium on eClinical technology and other resources that empower CROs to better navigate that competition.
A new way of thinking about eClinical technology
The globalization of clinical trials has caused organizations to place stronger emphasis on certain priorities, chief of which is the need for the rapid collection and exchange of data across increasingly long distances. For a CRO in North Carolina working with a new site in China, the process of dispatching monitors for site visits or importing data through traditional means is, of course, significantly more costly and time-consuming than if the site were local or at least domestic. And as regions affected by disease outbreaks often lack the level of infrastructure that other regions enjoy, researchers can face barriers even to the use of technology such as electronic data capture (EDC), which has become all but standard throughout the rest of the industry.
This changes the calculus for organizations when it comes to clinical trial technology. Though CROs have historically been wary of eSource, for example, the ability of eSource to virtually nullify physical distance by enabling real-time remote data sharing could give them cause to reevaluate this position. The efficiency this unlocks could draw a lot of attention from sponsors looking to outsource more of their trials to CROs. Beyond eClinical technology, the use of wearable devices and other mHealth approaches could reduce or eliminate the need for site visits, thus helping to circumnavigate the challenges of running sites in regions with limited infrastructure. This could be a game-changer for CROs and sponsors alike, many of whom are keeping close watch on the logistical and regulatory developments around mHealth in clinical trials.
Globalization in clinical research is, of course, primarily a question of geographic distribution of clinical operations. But it’s also setting in motion a shift in conventional wisdom regarding all types of other matters – including technology. With the rise of outsourcing creating new opportunity, will CROs be able to reassess their reservations about eClinical technology like eSource – as well as other innovations impacting the industry – and compete in the new market?