Digital Transformation of Clinical Trials Transforms the Drug Development Landscape

Digital Transformation of Clinical Trials Transforms the Drug Development Landscape TrialsiteN

Is the technology sector key to helping biopharmaceutical sponsors solving patient recruitment and patent engagement challenges? What is the future of “digital health” in the drug development industry as countless “digital deals” are occurring in the industry while deals also unravel and disappoint? What are the two ways that digital will help industry sponsors transform bringing drugs to market?

Arriving at an inflexion point, drug development sponsors, sites and partners face the reality of exciting transformation (or great disappointment) thanks in great part to a surge in digital transformation options made possible by 1) advent of ubiquitous and cheap cloud computing; 2) emergence of dynamic of mobile and smartphone-based platforms and applications; 3) development of health-centric “internet of things” or IoT (e.g. sensors connected via internet); 4) explosion of available personal health information now available in digital form and 5) rapid rise of artificial intelligence (AI) or the Machine. All this combined with breakthroughs in precision or targeted therapies and treatments as well as devices and diagnostic advancements creates recipes for complete and total industry transformation. Are you ready?

 These are topics picked up by Laura Lovett with mobihealthnews who covered the recent Connected Health Conference in Boston where Bob Coughlin, executive director of the Mass Biotech Council, and Dr. Joe Kvedar, VP of Connected Health at Partners discussed the future of digital in life sciences. 

Dr. Kvedar summed up the overall positive digital trends driving two ways including 1) the use of sensors to better execute studies and 2) digital infused throughout for more efficiently executed clinical trials. Ms. Lovett reports that Kvedar believes that the same ways that developers work magic to keep consumers “addicted to our phones” should be employed to get individuals “addicted to healthy behavior.” No one has arrived at this level as of yet.

Digital Research Platforms

mobihealthnews’ Lovett raises some examples such as Verity’s (Google) new partnerships with Novartis, Otsuka, and Sanofi to utilize the Verily’s Project Baseline platform in the quest to diversity study populations with the goal of simplifying participant enrollment and health care engagement. Since the 2017 Project Baseline as been employed by clinical researchers seeking to collect real-world evidence via electronic health records, wearable sensors (Verily Study Watch) and other digital sources such as sensors in wearables, etc. 

The digital ecosystem transforms, possibly, top-down engagement (from sponsors down to site down to patient) to horizontal, dynamic “patient-facing” ecosystem making participant enrollment, instruction and self-reporting increasingly interesting. So for example platforms such as Study Watch make it incredibly easy to organically collect all sorts of patient health data and then on the other side organize that data and make available a presentation layer for either study coordinators or monitors—with everything from decision support dashboards various analytical tools.

Disease Management and Care via Wrap-Around Products

Perhaps pharma will use digital to support disease management care suspects Kvedar reports mobihealthnews. Examples mentioned include injectable or medication that includes a sensor and/or app to help track adherence.

The recent Sanofi and Abbot deal would support this position where Abbott’s continuous glucose monitoring system (FreeStyle Libre) gets augmented by the pharma’s insulin dosing information to produce “smartpens and insulin titration apps.”

Learn from Others

Kvedar suggests that the industry should move carefully with digital tools. For example, if pharma just turns the “Direct-to-consumer” team loose it may not create the transformative results sought. Moreover, Coughlin suggests that pharma should study how other industries are successfully facilitating engagement with digital apps and that in many cases pharma was already doing this. For example, he is quoted that “In the biopharma space we have to stop with the arrogance that we are so smart [and] that we have to invent everything for ourselves on our own.” He (Coughlin) concluded, “Why don’t we use that technology to try to invent drugs, quicker, better, faster, cheaper.”

Put your Seatbelts on: Schumpeter’s Gale is here

Whether you work for a clinical sponsor, research center or partner organization how will digital and the ongoing scientific and medical breakthroughs occurring at breakneck speed disrupt and transform your current reality in the short, intermediate and longer-term? The stakes are big.

Our favorite economist Joseph Schumpeter educated those willing to learn how in a capitalistic economy (such as what we have in most of the world today) will undergo “Creative Disruption” or what became to be known as “Schumpeter’s gale.” Ironically first identified by Marx and popularized as a theory in “economic innovation” and “business cycle” literature, “the gale of creative destruction” describes the “process of industrial mutation that incessantly revolutionizes the economic structure from within, incessantly destroying the old one, incessantly creating the new one.” Great practical examples are everywhere. Look what Uber and Lyft have done to the taxi business. Amazon is wiping out many retail realities as we know it even to the point where land-use patterns transform in America. What kinds of creative destruction is occurring this very moment in the world of drug development? Examples abound.