Kevin Monroe

	In the following Q&A, Guillaume Marquis-Gravel, MD, a research fellow with the Duke Clinical Research Institute (DCRI), and Kevin Monroe, director of innovation at DCRI, discuss the advancements and related challenges of incorporating new technological tools into drug development, including eClinical approaches currently undertaken in the foundation’s own studies.

Can you provide an overview of the software and technologies the DCRI uses in clinical trials and why they’re being used?

	Technology plays an increasingly integral role in the research process. As a research organization, the DCRI utilizes a bevy of software products to facilitate the execution of research projects and the data analysis of findings. These include tools to: 

		Streamline site selection and activation 

		Enrich patient recruitment and retention efforts 

		Facilitate contracting and payment processing,

		Collect data from patients, providers, and health systems (including range of EDC, EHR, ePRO, eCOA, clinical registries)

		Monitor data collection and safety profile

		Evaluate and adjudicate clinical endpoints

		Provide ongoing project management, study oversight and reporting 

	Historically, many of the tools needed for research have been provided through in-house software development efforts of niche vendors largely architecting their solutions through on-premise infrastructure. With the explosive growth of cloud technologies, the vendor landscape has grown dramatically. 

	While the DCRI continues to utilize many solutions designed for our specific purposes, the trend toward cloud-based solutions is clearly underway. With this rapid rise of viable solutions, the challenge has changed from an era of too few solutions to navigating a complex landscape of point solutions. The ongoing efforts to provide a platform and ecosystem for clinical research is a long overdue and an advance which we welcome enthusiastically.

When so many processes are still conducted on paper, can the right technology make or break a clinical trial?

	Inasmuch as technologies can provide economies of scale at every stage of the trial process, from design to analysis, poor implementation can lead to wasted resources. Capitalizing on the efficiencies enabled by technologies to facilitate the conduct of clinical trials requires the expansion of the study team to include information technologies specialists, health systems specialists, and data scientists. 

	Also, experts in advanced analytics are the linchpin required to enable the integration of massive volumes of data accrued through emerging technologies. EHR-based, electronic patient-reported outcomes (ePROs) from mobile health applications and digital biomarkers derived from biosensors allow researchers to streamline safety monitoring and endpoint ascertainment processes by eliminating requirements for in-clinic follow-up with traditional paper-based case-report forms. 

	However, no compromise on the quality of data can be made, as evidentiary standards for regulatory and scientific purposes needs to be maintained. For example, before replacing traditional central blinded endpoint adjudication by EHR-derived data, completeness, accuracy, and precision of the data requires validation efforts to be conducted, and regular curation of the databases is necessary. Digitization of the protocols has the potential to generate efficiencies and support complex operationalization of protocols at the site level, at the cost of extensive training for the personnel in charge of digitization. 

	Inaccurate data attribution, mobile device failure, programmed obsolescence, and silos of representativeness excluding participants with poor technological literacy all constitute challenges specific to the conduct of technology-enabled trials that have to be taken into consideration early in the planning stage to ensure quality and efficiency in the conduct of trials.

If you had one technology to use on a clinical trial, what would it be and why?

	Shifting the paradigm from site-centric to patient-centric clinical trials is best exemplified by the conduct of the so-called virtual trials (also called decentralized trials) made possible by a set of mobile technologies to continuously capture ePROs and digital biomarkers such as step count, heart rate, and blood pressure. Upon proper validation, these web-based platforms-where patients can be consented, interact with investigators through telemedicine devices, record ePROs, and automatically upload vital signs through applications on the participants’ own smartphones-not only have the potential to reduce the time burden imposed on the participants and study teams by obviating the requirement for traditional in-clinic study visits, but also permit continuous real-time data collection more representative of the daily living environment of participants, and empower them to be more engaged in research.

Are there any processes currently conducted on software programs that you have found problematic, wanting, or all-over challenging?

	The movement toward technology-enabled clinical research in which software products are integral to the research process does introduce new challenges. As new products are introduced, they require a comprehensive approach to change management both within the coordinating center as well as the participating research sites. Simply navigating the current model of numerous point solutions is challenging, as each offering has its own unique benefits and difficulties. Common product-level challenges include poorly designed user experiences and reliance on built-in data visualizations and reporting with limited ability to access raw data. Many of the solutions fail to adequately address the totality of the problem space in which their offerings focus. 

	For example, while numerous products focus on the study startup process, the results have not been as successful as anticipated largely because they are designed from a study-specific focus, whereas both the coordinating center and research sites are managing their own unique portfolio of research studies. Platforms that empower both perspectives with an enterprise approach are needed to realize the economies of scale envisioned. 

	It is clear that the clinical research industry has evolved from a reliance on paper processes to a reliance on software products, and is currently in the midst of an evolution from software products that are provided as point solutions to one in which platforms and ecosystems will be essential. 

, a research fellow with the Duke Clinical Research Institute (DCRI), and 

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In the following Q&A, Guillaume Marquis-Gravel, MD, and Kevin Monroe discuss the advancements and related challenges of incorporating new technological tools in drug development, including eClinical approaches currently undertaken in the foundation’s own studies.

Kevin Monroe

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Q&A: Capitalizing on Technology-Enabled Clinical Research