Clinical trials are on the move, with an increasing number of sponsors exploring ways to bring their studies closer to local communities and the potential participants within them. The hope is that, by reducing barriers to participation for both patients and their support networks, clinical research sponsors can achieve wider and more diverse enrollment, thus boosting the quality of the data needed for drug approval.
Driven by this motivation as well as a widely recognized belief that traditional clinical trial models place unnecessary burdens on participants, the industry has started to shift from conventional site- centric visit models to ones that offer participants more convenient options, including visits directly in their home or another location of their choice. This type of community-based research model is typically supported by Good Clinical Practice (GCP)-trained registered nurses, who perform aspects of the protocol such as drug administration or patient follow-up in a mobile setting.
In 2024, GlobalData collaborated with leading community-based research company, PCM Trials, to understand the role that mobile nurse visits play in clinical trials. We surveyed 100 industry professionals with experience or knowledge of mobile research to understand the biggest advantages and challenges of implementing mobile visits in clinical studies, as well as the types of patients most likely to benefit from this alternative visit model. In the first article in this two-part series, we combine the survey findings and prior interviews with industry experts to understand the role that mobile visits are currently playing in clinical trials.
Diving into the benefits
One thing is clear from the survey findings: using mobile nurse visits in clinical trials offers a range of benefits. The primary advantage cited was an increase in patient retention, with 91% of respondents agreeing with this statement. Given the many benefits referenced in the survey and the wide range of therapy areas and patient populations where mobile visit deployment was deemed suitable or beneficial, it is not surprising that 97.5% of the forty respondents who had utilized mobile nurse services in their own trials said they found the services effective in meeting their goals.
“Since clinical trials are often several stages, home visits can help with retention,” Jenifer Ngo Waldrop, Executive Director, Rare Disease Diversity Coalition, tells Arena International (a GlobalData company). “By having someone come to you or checking in virtually, this would adhere closer to trial protocol and align it with the daily life of the patient. Going to the patient can also provide a more accurate reflection of the patient’s experience.”
Reducing the number of visits required at the study site could not only mean that more patients are retained in a trial but also that their compliance to the study protocol is improved, believes Thomas M Tremblay RN, BSN, Vice President of Clinical Development at Hallux Inc, a specialty pharmaceutical company focused on breakthrough solutions for onychomycosis.
“By decreasing the burden on study subjects by allowing follow-up visits that do not require the investigator and are within the scope of practice for registered nurses and nurse practitioners, protocol compliance could be greatly improved,” says Tremblay. “If patient compliance is increased there should be fewer late/missed visits, missed assessments, and study drug compliance could be increased.”
Interestingly, however, it is not just participant burden that the industry is keen to reduce. The ability to alleviate burden on sites, which are often overwhelmed by their patient numbers, was the second-most cited advantage of mobile visits, at 76%.
Mobile nurse visits: Who, what, why?
Increased patient diversity was another major benefit that appeared in survey findings, with 58% of respondents believing that mobile nurse services could help sponsors achieve diversity goals. This potential also surfaced in another question, where 57% cited racial and ethnic minorities as a type of patient population that could benefit from a mobile visit option.
Clinical trials have historically struggled to enroll sufficient participants from minority groups for a variety of reasons, including limited awareness of research and a historic mistrust of healthcare systems. Beyond these hurdles, it is essential to recognize the significant role that socioeconomic factors play in an individual’s capacity to engage in conventional site-centric studies, making alternative options like mobile visits a promising strategy for overcoming access-related hurdles.
Survey findings also indicated that rare disease patients represent a key population; two-thirds of respondents believe these patients would benefit from mobile nurse visits. Ngo comments: “From the rare disease patient perspective and someone who is from the historically marginalized populations, I have heard the benefits of having visitors come to their home so that they could be a part of a DCT [decentralized clinical trial]. Since symptoms can create mobility issues, there is a convenience in being able to participate from home.”
The same can be said for elderly patient populations, which are most likely to benefit from mobile visits as indicated by 94% of respondents. In previous research, GlobalData has observed expedited enrollment periods and trial durations for trials that enrolled geriatric patients and used mobile visits. In a group of trials matched by therapy area, region/country, and modality, enrollment for studies utilizing mobile visits was shorter by an average of 6.18 months compared to those without, while trial duration was shorter by an average of 10.97 months.
Meanwhile, there were no clear front runners when respondents were asked to identify the specific therapeutic areas they felt could benefit most from mobile nurse visits. With answers divided fairly equally across the six options provided, this suggests that mobile visits could be suited to a wide range of indications, with the potential to improve research for many thousands of patients.
In the second part of this series, we will look towards the future of mobile visits in clinical research, answering questions such as how many respondents plan to deploy mobile visits in upcoming studies, and how many believe usage will continue increasing over the next five years. We will also unpack data around the challenges of implementing mobile visits and the biggest obstacles to their widespread adoption.
For more information on mobile visits and other forms of community-based research, please download the whitepaper below.
