Technology’s Impact on Data Acquisition Processes in Clinical Trials
Q: We’ve heard you say that data acquired throughout the clinical research process must be complementary to clinical care goals. However, CROs are sometimes perceived as caring more about the technology being used to acquire the data than the data itself. Why is that?
Dr. Murphy: Given the business models of CROs, it is a common misperception that the incorporation of new technology into the trial process occurs simply in service to novelty, or in an effort to achieve service differentiation. However, novel data acquisition processes exist to enable the clinical research process and maximize the efficiency and value-added activity of CRO staff. There is a strong regulatory endorsement for the use of a variety of platforms in data acquisition, as it provides consistency and reliability, permits innovative approaches to trial design and analyses, and these technologies are foundational for participating in various permutations of risk-based monitoring. New technology that is incorporated with a thoughtful, programmed approach by a CRO facilitates the drug development process (e.g., study startup activities, electronic source documents), enables innovative trial designs (e.g., adaptive studies), changes the point of data collection for many types of studies (e.g. from clinics to the home), and—most importantly—increases the time available for professional contributions from CRO staff.
Q: You’re saying that data acquisition through the use of novel technology will facilitate patient-centric and site-oriented research. How do we make that happen?
Dr. Murphy: Clinical research data are derived from physician/patient interactions in which the process of those interactions, including the collected information, are determined by the design of the protocol. Technology that is transparent to those interactions, while also satisfying reliability, sensitivity, various aspects of validity, and attribution, can be transformative. However, the skills required to participate in that process, particularly by site-facing CRO staff, are clinical. They arise from an appreciation of patient management issues and site dynamics occurring in clinical research against a backdrop of clinical care. This is particularly important for therapy with breakthrough characteristics targeting unique patient phenotypes that are commonly encountered in the current research setting. CROs that highlight the importance of clinical acumen through credentialing and training programs provide a differentiated business model–one that emphasizes that technology exists in service to clinical research.
Q: What is the role of the CRA (Clinical Research Assistant) in that regard? Any recommendations to help them succeed in their roles?
Dr. Murphy: CRAs are specialists in applied clinical research. Emerging technology increasingly permits the CRA and other operational staff to “live in the data stream,” while simultaneously enabling monitors to spend more time reviewing critical study-related issues, assessing protocol compliance, monitoring for patient safety, and gaining more insights regarding the impact of novel interventions on patient care. With the introduction of facilitative technology, the ultimate expression of the art thus becomes site management, analytics, and monitoring data for “medical meaningfulness,” as well as integrity. A therapeutically focused, tech-savvy CRO will assist its CRAs in developing these skills, by using technology that enhances the benefits that accrue by allowing staff to “stay in the vineyard.” Therapeutic focus coupled with enabling technology helps each CRA gain a deeper understanding of the disease management process, the rationale for therapeutic and investigative interventions, and the diverse mosaic of assessments that are specific to each therapeutic indication which demand informed monitoring. With this perspective, cost savings that come from enhanced technology become a secondary consideration, and value-added monitoring services with a strong clinical orientation by a CRA become the real differentiator for the CRO. To learn more about how Worldwide Clinical Trials manages and structures the data accrued from its own clinical research, go to https://www.worldwide.com/technology.
Part 2, Q&A Series: Dr. Murphy and Technology’s Impact on the Clinical Trial Process