Agios

Nick Hargaden

The Impact of eClinical Technologies on Clinical Trials

The word “transformational” is frequently used by eClinical solution vendors and clinical trials professionals to describe platforms, solutions and applications of technology. Sometimes that transformation is significant and fast moving,centered on one part of the clinical trial ecosystem such as the advances in remote data capture that gave us today’s “new normal” of EDC. Sometimes the transformation happens over decades, for example the use of interactive response technology has been a key facilitator of increasingly complex packaging strategies, visit and dosing schedules. More recently, electronic trial master files have begun to automate the study filing process; a substantial change to the way we maintain inspection readiness. Yet in most cases the eClinical solution primarily automates an existing business process; as ATMs automated the work of bank tellers, EDC automated the job of getting data from site to statistician.

Disruption over Transformation

So whilst eClinical technologies have undoubtedly transformed many aspects of clinical trial planning and execution, have they truly disrupted it? Take Uber in comparison. In one sense, Uber is just a new way to call a taxi. But what Uber does could never have worked without technology: the data sharing and on demand processing power brought by cloud computing. It has fundamentally disrupted the business model for taxi services, from capital investment (Uber does not own the cars) to pricing (dynamic demand based pricing and matching riders with ride-shares) to creating a workforce that can be scaled up and down as required by the circumstances. Uber is a taxi company that would be unrecognizable to the taxi companies of even 15 years ago. 

Real World Evidence and the Virtual Trial

It may be that the development of virtual trials and the increasing use of real world evidence (RWE) will drive true disruption. Leveraging the technology of the 21^st century (cloud computing, wearables, mobile devices and more), in 20 years we could have clinical trials that are unrecognizable compared to how we work today. 

How do you plan and execute clinical trials where sites are no longer the center of the trial, where the data could be coming from multiple external sources and largely directly from the patient? How do you maintain patient safety and privacy and ensure data integrity? Like Uber with the taxi industry, perhaps the CROs in 20 years time will be unrecognizable next to those of today; fundamentally technology companies that store, share and process data, rather than complex services companies that leverage licensed or purchased point solutions for incremental efficiencies and market advantage.

The Opportunity for eClinical; What’s Next?

If virtual trials and RWE truly disrupt the business of clinical trials, we may see a move from point solutions to eClinical ecosystems.Early signs of this can be seen in content management platforms that truly leverage the cloud to make the content (which is just bundled data) available to multiple solutions and for different uses at the same time. This approach, common in B2C technology platforms, moves beyond the focus on copying and transforming data to push from one isolated system to the next. As the business processes are disrupted so will the solutions be disrupted that have been developed to mirror them. Perhaps instead of automating existing processes, we will be inventing new ones.