Digital Trials Digest, our quarterly newsletter
Renovia needed a solution to evaluate the efficacy of its leva® Pelvic Health System for treating urinary incontinence, while ensuring ease of use for a busy female population. Of particular importance was enabling real-time symptom tracking and maintaining high patient engagement—without requiring in-person site visits.
In a recent study, we found that caregivers both underreported and overreported certain stool consistencies compared to clinician ratings. We need to make it easier for parents to report in clinical trials. See why digital image capture is an improved method for assessments of treatment efficacy and health status for pediatric GI research.
In the second of our two-part series, we explore how integrating mobile technology into study design can help attract and retain minorities and women as trial subjects.
With travel hampered and clinical trials disrupted, it’s difficult to conduct on-site clinical trial monitoring. The alternative — remote monitoring — has always made sense, but now this cost-effective, time-saving model is rightfully gaining steam. Remote monitoring in clinical trials means monitors don’t visit the site to transfer and review the data. Instead, the data monitoring is done virtually. With the use of digital technology, CROs and study sponsors/stakeholders can see the data from wherever they are located.
DCTs offer an effective avenue for studying what are sometimes considered “taboo” therapeutic areas while respecting participants’ discretion.
The challenges associated with conducting central nervous system clinical research all impact sponsors’ and study teams’ ability to gather stronger therapeutic evidence—but they also prime CNS studies for decentralization.
Many clinical trial sponsors don’t understand how decentralized clinical trials (DCTs) fit within today’s regulatory landscape. This lack of familiarity with decentralized research and regulatory approaches has created DCT hesitancy among sponsors.
Patient engagement in clinical trials can make or break a study. Engaged patients are more likely to participate and complete studies, which can strengthen data collection and, ultimately, provide more robust therapeutic evidence of safety and efficacy.
Clinical trials lay the foundation for breakthrough drugs, digital therapeutics, and medical devices—and, at the center of these studies are the patients.