• Clinical Trials

    Mayo Clinic Proceedings explores digital transformation of clinical trials

Mayo Clinic Proceedings published a comprehensive series, "Forward Thinking on Clinical Trials in Clinical Practice," from August 2023 through April 2024. The series explores:

  • Pragmatic clinical trials, which consider how an intervention may affect a patient's condition in the real world, and how to effectively use these interventions in clinical practice.
  • Decentralized clinical trials, made possible by new technology that improves the experience for participants, expedites results and may reduce costs.
  • Community engagement with minority and underserved populations, to assure the diversity of participants and improve the accuracy and relevance of results.
  • How to counter health inequities through technological and research design innovations.
  • Ethical and regulatory challenges of emerging health data platforms.

Series highlights:


"As technology advances, such as in the areas of artificial intelligence and decentralized trials, new clinical trial designs will be needed to ensure scientific rigor," the introductory essay says.

"Clinical Trials Overview: From Explanatory to Pragmatic Clinical Trials" outlines the values and qualities of trial designs, how each is chosen and the critical importance of scientific rigor, regardless of design and approach.


The benefits and challenges of decentralized clinical trials powered by technology are the focus of "Data-Driven and Technology-Enabled Trial Innovations Toward Decentralization of Clinical Trials: Opportunities and Considerations." Researchers now have the technology to conduct clinical trials in which all or part of the trial-related activities occur in the patient's home environment. These decentralized trials allow for a more patient-centered approach that improves recruitment and convenience, reduces expenses, and reduces inefficiencies and logistical barriers.


"The Digitization and Decentralization of Clinical Trials" describes how researchers are harnessing vast amounts of newly accessible data to conduct more robust investigations, unrestricted by geographic or clinic-centric limitations. Using technology to move trials outside the clinic and institutional walls allows more people to participate in pragmatic studies and provides real-time data for investigators. It promotes inclusion of those who have been and continue to be marginalized by the "digital divide," the gap between those who have access, resources and familiarity with digital technology and those who do not.


Pragmatic clinical trials, which evaluate the effectiveness of an intervention on a patient's condition in a real-life practice setting, were the focus of November's review. The article, "Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies," presents three recent case studies with different approaches to the implementation of pragmatic clinical trials and their strategies for data and safety reporting and interpretation.


LaPrincess Brewer, M.D.

Digital technologies are transforming the design and implementation of clinical trials, but safeguards are needed, as explained in the review: "Health Disparities, Clinical Trials, and the Digital Divide.

"For digital solutions to truly improve healthcare and clinical trial participation for all persons in an equitable way, targeted interventions to address historic injustices and structural racism in how clinical research has been conducted are essential," writes LaPrincess Brewer, M.D., a Mayo Clinic cardiologist and the review's senior author.


Folakemi Odedina, Ph.D.

Community engagement is key to reducing racial and ethnic disparities in clinical trials, according to the January review: "Community Engagement Strategies for Underrepresented Racial and Ethnic Populations."

"Through careful deliberation and involvement with community partners, researchers can develop tailored blueprints for clinical trials that can ensure that our science reflects the needs of all populations," says Folakemi Odedina, Ph.D., first author of the article.


Designing clinical trials relevant to special populations often underrepresented, such as children, older adults and people with rare diseases, requires a determined strategy for community engagement. This review, "Clinical Trials for Special Populations: Children, Older Adults and Rare Diseases," calls for innovative and consistent communication with patients and families, among other strategies.


Frontline healthcare workers have much to contribute to how pragmatic clinical trials are designed and implemented, and their work can assure more relevant outcomes, according to the article, "Building Capacity for Pragmatic Trials of Digital Technology in Primary Care." Involving primary care clinicians early in the trial design process can help improve recruitment from underrepresented and socially disadvantaged populations, the article says. It also proposes ways to best use the input from frontline healthcare workers.


Appropriately, the final installment of the series zeroes in on translating research data into practice, by raising awareness of translational and implementation science in clinical research. The article, "Advancing Translation of Clinical Research into Practice and Population Health Impact Through Implementation Science" focuses on how implementation science can help address unmet healthcare needs and emphasize generalizable solutions to persistent challenges in translating innovation to practice.

To read more, visit Mayo Clinic Proceedings: Innovations, Quality & Outcomes and Mayo Clinic Proceedings: Digital Health.