Medidata Blog

Failure (to Innovate) is Not an Option

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Disruptive innovation. Sure, the term is a buzzword. But maybe it’s more than that. As someone who’s long followed the wisdom of Clay Christensen, I have a healthy respect for the concept of “innovation.” But lately it doesn’t seem to go out without its new BFF, “disruptive.” We at Medidata talk about it a lot. And we are certainly doing a lot to disrupt the broken processes and technologies of clinical research. But earlier this week, I decided to see what the rest of the industry had to say about things. As an attendee at the first annual Disruptive Innovation in Clinical Trials Europe conference, held 4-5 March in London, I heard from a bevy of senior decision makers and trend-shifters in clinical R&D about what THEY thought disruptive innovation in clinical trials looked like. The bad news is that the industry is really in need of innovation, and it’s gotten to the point where it needs to be disruptive and not merely incremental. The good news? Opportunity abounds! People are finally waking up to this fact—which we’ve been shouting from the hilltops for years—and from what I saw, the technology we develop and the best practices we espouse can really help. A few themes stood out to me over the course of the agenda. First, the role of the patient. Whether it’s patient engagement, patient-centricity or however you refer to it, we need to get patients more involved and interested in clinical research. I’m not the first person to write about this topic on our blog and I’m sure I won’t be the last. Some of the ideas that stood out in this vein were involving patients in protocol design, the move to personalized medicine, and a personal favorite, bring-your-own-device patient data capture. All can make a big impact in the way we conduct clinical trials. At a minimum, I think we can all agree that referring to patients as “subjects” should be a thing of the past. The second big theme I heard during the event was how consumer technology has far surpassed clinical technology. One funny comment I heard was from an R&D executive, who felt that when he left the office, he “returned to the 21st century.” My colleague Rebecca Jackson—whose presentation on Tuesday rhetorically asked whether we in clinical research were smarter than NASA—even included a graphic highlighting how the iPhone in her pocket is now significantly more powerful than the NASA computer that put Neil Armstrong on the moon, yet our clinical infrastructures are still based on 1980’s computing paradigms. Finally, the theme of technology facilitating higher value contributions came up a lot. This is particularly exciting in terms of risk-based monitoring. Too often, sponsors and CROs have viewed risk-based and centralized monitoring as a means to stop traveling altogether. This is a frustrating missed opportunity. Utilizing technology to facilitate risk-based monitoring, whether a planning tool like Targeted SDV or a business analytics tool like SQM, provides sponsors and monitors to better manage site visits, providing site personnel with higher-level information as opposed to the relatively low-level process of SDV. Risk-based monitoring adoption can be disruptive, but not by letting monitors work from home. This event was an exciting and inspiring one. My hat goes off to the folks at Health Network Communications who organized the show and the participants, both delegates and speakers. We at Medidata have long felt that it’s crucial for the industry to find better ways to innovate, and after this week, I am more confident than ever that the industry is coming around to the same conclusion. *Guest blogger Joshua Pines is director of EMEA marketing at Medidata. You can reach Joshua by email or follow him on Twitter @joshpines.

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