It is indisputable that digital technology has changed every aspect of our lives. Children learn to use a computer before they learn to read. Teenagers and college students connect on Facebook rather than on the phone. The morning newspaper is delivered on the Internet. Television is digital. Professionals entering the job market consider laptops, smartphones and all sorts of other digital equipment as essential tools to work and play. Even seniors are adept at managing their bank accounts online and rarely step inside of banks.
What digital technology provides at our fingertips is instant access to information we used to look for by thumbing through reams of paper and the ability to make quick effort of both laborious and menial tasks.
THE PAST: Clinical research digitization slow to catch on
Clinical research, a science that generates, collects and analyzes large amounts of data, lends itself naturally to the digitization process. However, the adoption of information technology in clinical research has been glacially slow when compared to other industries and the mass adoption of the Internet.
Why has it taken so long? I agree with my colleague, Dr. Joseph DeVeaugh-Geiss, who feels that part of the reason for slow adoption is mindset. “You have to get through to the generations that you can make a transaction without touching a piece of paper,” he said.
An early adopter of digitization while he worked in the pharmaceutical industry, DeVeaugh-Geiss has helped companies and government agencies with drug development and research since retiring as GlaxoSmithKline’s international director of central nervous system clinical research.
And it’s not just individual resistance; it has largely been organizational resistance to transition away from what has worked well for decades. Just like the mimeograph machine worked well in its time, today the modern copy machine far surpasses it in terms of function, cost and efficiency – in other words – productivity. To be fair, early concerns about data security, the possibility of technical glitches and moving data from clinical sites across the world have legitimately contributed to the slow adoption of technology in clinical research, but it is time to move beyond this.
THE PRESENT: Smart CROs taking technology-driven approach
Technology has been deployed in many industries to achieve efficiencies and cost savings. Consider automated manufacturing and quality standards first developed by Japanese carmakers, computer-aided design and manufacturing in engineering to develop and make tools, or flight simulators to train pilots.
To be clear, the digitization of the clinical trial process is about far more than just collecting data electronically – it’s about providing an optimized, modern and powerful chassis to the entire event known as a clinical trial. It’s about fundamentally changing the way trials are run. If done right, I believe digitization can eliminate many of the inefficiencies that hamper trial progress, while reducing costs and speeding up the drug development process. With about half of all clinical trials now using Web-based tools to capture, manage and monitor data, we are just now on the edge of the chasm and just beginning to see how fully technology can reinvent the clinical trial. Why now?
The business of taking drugs, biologics and devices from the bench to the patient is under significant commercial, governmental and social pressures regardless of the size of the company. Choosing a digital approach makes sense because these solutions can enable development teams to run trials cheaper, faster and more efficient than paper-based approaches.
One of the main advantages of digitizing clinical trials is the ability to centralize study information and coordinate multiple trial processes in real time at a lower cost, as the Journal of Medical Internet Research points out.
Clinical trial data from a dCRO can make it easier for an FDA reviewer to cross-check vast amounts of safety information while also allowing for quicker responses should drug safety become an issue during a trial.
My colleague Dr. William McCulloch, who has worked as a senior R&D executive for large and small companies, has found in his experience that a dCRO enhances the understanding of what causes adverse events during clinical trials and allows for a faster follow-up. According to McCulloch, the ability to check out a certain side effect within the seven days before it has to be reported to regulators may save a clinical trial.
Digitization also allows for real-time remote monitoring of investigator sites, cutting down the number of on-site visits required to ensure data is generated and collected according to protocol. Reducing the number of on-site visits in turn reduces the need for site monitors while problems at far-flung sites can be detected and fixed much more quickly.
“The gun fire is faster,” McCulloch said.
But not all CROs are the same. Most CROs and sponsors, while embracing technology more commonly, still fall prey to the fundamental mistake of simply layering technology on top of existing manual processes. Adding technology to a flawed process — one that depends heavily on people paid by the hour — doesn’t save costs. In fact, it has the opposite effect, creating a more expensive, complicated flawed process.
Smart CROs take advantage of technology to drive productivity and customer value by integrating technology in the way people are deployed. When technology replaces people as the backbone of clinical research, the costs of clinical trials can drop by 20-30% depending on the size and scope of the study. While that is powerful, by comparison the real-time visibility into the study that one achieves almost makes the cost savings irrelevant. How does one put a price on that?
THE FUTURE: Universal healthcare digitization on the horizon?
I believe the seismic opportunity in clinical research is the value that will be unlocked by the adoption of a universal electronic medical record (EMR). However, unlike many, I do not believe the benefit will lie in the ability for EMRs to be the vehicle running a trial and collecting protocol based data. The untapped potential in EMRs lies in their ability to identify study populations, conduct feasibility analyses, support patient recruitment, conduct screening and manage patient follow-up scheduling tied to study visits. Coupled with a clinical research platform, EMRs will substantially reduce time and cost in running trials.
The era of EMRs is clearly upon us. Already Google offers server space to store health care records, a new administration in the White House is encouraging healthcare organizations to eliminate paper in their practices and Medicine 2.0 is the latest buzzword.
Within the next 20 years I believe healthcare organizations will become (generally) paperless. Now is the time however, to begin re-engineering the way we run trials. We do not have to wait until anything new appears on the horizon to provide a significant benefit to trial sponsors today. We have the technology, the benefit of early adopters and a few digital CROs who get it. There simply is no excuse to continue to use the mimeograph.