Will Mobile Visits Help The Clinical Trials Industry Meet Its Diversity Goals?

Clinical trials are falling short of representing the complete diversity of our population, resulting in two significant consequences for underrepresented groups. Firstly, they lack an equal chance to avail themselves of innovative medical treatments under investigation in trials. Secondly, when these treatments become commercially available, the safety and efficacy data used for their development and subsequent approval may not accurately reflect individuals of all ages, genders, races, ethnicities, and body weights. Recognizing this diversity challenge, sponsors and regulators across the industry are taking proactive measures.

In 2022, the FDA acknowledged that certain aspects of trial design, such as the "frequency of study visits, time and resource constraints for participants," and challenges related to "transportation and participation conflicting with caregiver or family responsibilities," act as barriers for many patients from specific demographics.

As part of the decentralization trend, mobile nursing visits have gained traction. This approach aims to alleviate the participation burden while enhancing patient safety, engagement, and adherence to protocols. By integrating visits into patients' daily lives, explore how mobile visits could significantly enhance diversity and inclusion in clinical trials.