With decentralization now widely recognized as an established tool in the clinical trial toolbox, an increasing number of sponsors and investigators are becoming familiar with alternative methods of participant engagement. One of these involves deploying mobile research nurses directly to participants, allowing people to participate in clinical trials at a time and place that works best for them.
Interest in mobile research services has grown significantly since the pandemic as more sponsors realize the positive impact that optionality could have on overall trial participation, diversity, and retention. With the heightened interest has come a degree of curiosity and uncertainty about how mobile visits work and who can benefit from them. To understand more, we spoke to PCM Trials, the industry’s longest standing provider of mobile research services, to address five common misconceptions.
1. A different nurse visits the participant every time
One misconception surrounding mobile visits is that trial participants receive research services from a different nurse during each study visit, leading to an inconsistent experience. Decentralized or not, the clinical trial experience can be difficult for participants and their families, particularly where children, elderly people, and challenging disease states are concerned. PCM Trials strives for consistent assignment of its certified mobile research nurses (CMRNs) whenever possible to facilitate trust and familiarity between the participant and nurse. This can ultimately lead to improved protocol compliance and overall study retention.
Several factors are considered during CMRN assignment, including the nurse’s experience, skill set, and location, as well as any project-specific requirements. Prior to the first visit, mobile visits are typically scheduled between the CMRN and participant over the phone. This allows for initial introductions and provides an opportunity for the CMRN to answer any questions the participant may have. In-person or virtual meet and greets are also offered if requested.
2. The nurse arrives at the participant’s home in a vehicle or clothing that announces their trial participation to neighbors
With some patients preferring to keep their disease and/or trial participation private, there is a concern that this privacy is not possible with mobile visits. At PCM Trials, CMRNs dress within the expectations of their profession but do not wear scrubs with company logos. They provide their own transportation to and from the mobile visit location, using personal vehicles which do not feature company branding.
Project managers work closely with sites to understand any special considerations, and site personnel are encouraged to escalate participant preferences prior to the first visit to ensure the mobile nurse can accommodate them appropriately. Options to ensure discretion and privacy for trial participants may include conducting visits in locations other than the participant’s residence or scheduling them at a particular time of day.
3. Mobile visits are only used for rare disease and pediatric studies
When mobile visits were first introduced, they were often utilized as a way of making trials more accessible for children and rare disease patients. Data-backed evidence is now emerging to suggest mobile visits have benefits for many diverse population groups, including those in traditionally underrepresented communities, helping sponsors increase recruitment by extending the reach of the traditional site network. The potential to improve clinical trial optionality now goes far beyond only rare disease and pediatric studies. PCM Trials has supported and continues to support more than 430 trials in more than 80 countries, delivering over 70,000 visits under protocols spanning a wide range of therapeutic areas.
4. Mobile visits can only be used in simple, not complex protocols
Executing successful mobile visits involves more administrative and logistical work than traditional site visits and can introduce different risks. PCM Trials works with sponsors to identify and mitigate risks at the start of every project. Risk analysis and mitigation is maintained throughout the execution phase, while logistical considerations are handled expertly by an experienced team of project leads.
Although mobile visits may not be suitable for all trials, many trial activities can be performed in a mobile setting while still maintaining strict adherence to study protocols. From a small-scale study requiring a single blood draw to a global, randomized trial involving intravenous (IV) infusions with pre and post-dose lab sample collection, processing and shipping, PCM Trials can provide research services via blinded and unblinded CMRNs. These highly trained registered nurses are able to complete various procedures within the mobile setting while maintaining blinding, IP accountability, sample viability, and subject safety.
5. Mobile nurses cannot administer investigational product (IP) by IV in the home
IV infusions are one of the more complicated and time-consuming forms of drug delivery, as well as one of the least comfortable for participants. As more sponsors consider incorporating elements of decentralization in their studies, there is a common misconception that IV infusions are beyond the scope of mobile research services. On the contrary, PCM Trials has supported many trials with this form of IP administration thanks to the careful attention and skill of its CMRNs, who are specifically trained to recognize, prevent, and manage the complications of peripheral IV therapy. By deploying the Gorski Model for Safe Home Infusion Therapy, the company reduces the risk of complications and provides effective assessment, monitoring and communication with sites.
To learn more about the use of mobile visits in clinical trials, please download the whitepaper below.
