Recognizing the Real People Behind the Big Data and Artificial Intelligence in Clinical Research

Londa Ritchey, MS, MBA, Quality Director with the Quality Management and Compliance group, PharmaLex

If you hadn’t already noticed, the clinical research enterprise has well and truly entered the era of “big data,” artificial intelligence (AI), and machine learning. One needs only to look at the industry press to see many recent examples of stakeholders making deals and rearranging assets in order to capitalize on what they hope will be breakthrough technologies and practices in terms of increasing efficiencies in drug and device research and development. At the same time, thought leaders in the field are endeavoring to ensure that real people—the ultimate beneficiaries of these rapidly evolving capabilities for clinical trial design and management—are not getting lost in the shuffle.

The forthcoming June issue of ACRP’s Clinical Researcher journal will feature submissions with a variety of perspectives on where these trends are taking us, and how research participants fit into the big picture. For example, Londa Ritchey, MS, MBA, Quality Director with the Quality Management and Compliance group at PharmaLex, writes about how “Putting the Patient First is Integral to Building a Strong Quality Culture.” She notes that a strong quality culture “focuses on assessing patient safety in all aspects and decisions of the company, not just within the quality department. Patient safety should be paramount in all decisions, big and small.” Further, “[t]eam members across all levels of the organization should be capable of making decisions on patient safety or raising concerns about it,” she urges.

Meanwhile, in “Designing High-Impact Clinical Trials That Serve Patients, Clinical Centers, and Industry Sponsors,” Erin Leckrone, MFA, MBA, Senior Director of Clinical Trials at the CIBMTR® (Center for International Blood and Marrow Transplant Research), writes about how “[a] collaborative approach to cell therapy clinical trial challenges pushes the boundaries of discovery and speeds life-saving treatments to patients. When organizations collaborate, sponsors can leverage unique expertise, unparalleled resources, and an established, stable infrastructure, including research, sites, donors, partnerships, and scientific and operational expertise. As a result, the time required to design, launch, and execute high-impact clinical trials is significantly reduced.”

Leckrone goes on to note how “[t]his collaboration can span the clinical trials continuum that starts with clinical trial design and management focused on the patient experience and ends with outcomes collection, research, and long-term follow-up. It also includes search and support services that help patients understand, find, and enroll in clinical trials.”

Going online on or near June 20, the new issue of Clinical Researcher will also include a peer-reviewed article by a trio of San Jose State University authors on “Forward Thinking for the Integration of AI into Clinical Trials” and columns on “Going Beyond the Guidance: Getting Business Benefit from Change Management,” “Improving Access and Participation in Clinical Trials Using a Patient-Centered Digital Health Platform,” “How Sponsors Can Support Sites with Data Analytics,” “Focus Investigator Meetings to Make the Most of Decentralized Clinical Trials,” “How Social Determinants of Health Affect Clinical Trials and What eClinical Solutions Can Do to Help Level the Playing Field,” and more.

Edited by Gary Cramer