Covance, a LabCorp (NYSE: LH) company and global contract research organization (CRO), recently announced their expanded solutions for decentralized clinical trials. This latest solution includes customized recruitment strategies, a global ecosystem of decentralized and patient-centric site visit alternatives, and novel ways to visualize data. They are banking that by offering these in a seamless, bundled way that they will disrupt current approaches by 1) expanding patient access to studies, 2) providing an improved patient experience, and 3) accelerate timelines for clinical development. TrialSite News reviews.
What is this new offering by Covance and LabCorp?
LabCorp acquired Covance so it is all part of the same company. Hence, they undoubtedly reviewed all of the assets both companies possess that could support virtual and decentralized clinical trials (e.g. HIPAA compliant call centers, back-end support services for patients, telehealth, apps, cloud offerings, etc.). They ultimately identified assets that could be brought together under one solution umbrella. So, for example, they identified LabCorp’s U.S.-based Patient Service Centers (PSC), including LabCorp at Walgreens locations, global partnerships with reputable pharmacies, as well as home health phlebotomy and nursing service providers—all connected by a best-in-class technology program as reported in their recent press release.
Faster Study Start up and Enrollment to Greater Patient Retention
Ultimately, the acceleration of clinical trial site initiation, study start up and the ongoing support of a patient-friendly study conduct towards close out represents a key objective. As technology supports decentralized approaches to studies, the use of various technologies can improve patient enrollment and retention, for example. Tie that together with back-end central laboratories, specialized diagnostic laboratories, direct-to-patient market access call centers, and a suite of technology solutions to bring the trial closer to the patient—streamlining trial execution along the way. There isn’t a doubt that Covance and the LabCorp parent possess the assets, capabilities and experience to offer compelling solutions. The have conducted over 15,000 clinical trials and undoubtedly have accumulated a wealth of knowledge as to what can work versus what cannot work.
A Leader in Virtual Clinical Trial Space?
TrialSite News cannot verify this. We can verify that Covance (under the LabCorp umbrella) is, we believe, the largest CRO. According to Bill Hanlon, PhD, president Enterprise Solutions, Covance has in fact established leadership in this emerging space and touts “Our latest solution includes customized recruitment strategies, a global ecosystem of decentralized and patient-centric site visit alternatives, and novel ways to visualize trial data. We believe that this solution will disrupt current approaches to expand patient access to studies, provide an improved patient experience, and accelerate timelines for clinical development.”
What is this Decentralized Suite?
Well, we were struggling to find details in their recent announcement. They did offer that the solution was “powered by a suite of integrated, modular, and highly configurable technology solutions that can be customized to deliver any conforming study protocol.” So, this could be the supporting of “end to end delivery of hybrid and virtual clinical trials by enabling data interoperability and seamless data collection” or tie together or integrate “connected devices, wearables and other mobile health technologies” to “capture primary and secondary endpoint data across multiple indications and connect patients, investigators and decentralized sites.”
Who heads this group within Covance/LabCorp?
Bola Oyegunwa, PhD, head of Virtual and Hybrid Trials Covance, notes, “We have re-imagined decentralized trials with our broad and unique collection of assets, including real-world data, access to a large patient population, a U.S.-based Patient Service Center network, and global logistics and supply chain enterprise.”
What is Designed Around You®?
According to their website, “Designed around you®” is the core of their decentralized clinical trials offerings where they offer the ability for the sponsor to “connect with more patients, virtually anywhere.” Their offering appears to be first and foremost consultative in that it offers tools but also techniques and services packaged into various options. Some key points for “Designed Around You” are:
· Customized to each clinical trial protocol along with the utilization of virtual and/or site-centric elements
· Virtual trials toolbox—can be used regardless of scale and are adaptable to protocol (however they don’t share with the reader what technologies are in the toolbox
· Incorporation of the patient voice—by using their Patient Direct capability—a direct connection to patients who meet the inclusion/exclusion criteria supplementing the investigator’s database/records. To enhance patient recruitment potential
This suite of consultative offerings (including technology tools) has been packaged together and offered to the market to help drive more patient-centricity, showcase integrated and modular supportive technology, introduce to the market unparalleled patient access and insights, and finally, tap into and leverage Covance’s deep expertise and experience to bring it all together.
Clearly Covance operates in a competitive milieu and doesn’t want to share any details with competitors. That is understandable, and we can appreciate that. However, they probably don’t share enough information for purposes of convincing the market.
Today’s buyer seeks to do a lot of their research prior to engaging with aggressive business development and salespeople. For example, under the “Hybrid and Virtual Trials” website, they don’t share any case studies—no names of any sponsors that are using these innovative and disruptive new tools for use in decentralized trials (whether they are virtual or decentralized). They don’t share any evidence for how this new offering—or elements of the offering—have quantitatively or qualitatively improved clinical trial outcomes (e.g. improve enrollment and retention rates for patients).
Indirectly, we found that they are aligned with upstart clinical trial digital app vendor Medable as they offered a joint webinar titled “Balancing Risk and Reward: How to Pick the Right Spot on the Virtual Trial Spectrum.”
But their Hybrid and Virtual Trials site is short on details, such as explicit identification of technology partnerships—for example, telehealth-based platforms are now used to support decentralized studies, and we couldn’t find any evidence of the embrace of some of these platforms. Moreover, they don’t readily offer any guidance, lessons learned or the best practices often incorporated in white papers that make for great reading (aside from the Medable video). It doesn’t mean they aren’t producing such important artifacts—it just means they are making it harder for the prudent researcher to identify and tap into evidence of success.