Mobile Research Nursing Helps Mitigate Challenges of Large Vaccine Trials

Mobile Research Nursing Helps Mitigate Challenges of Large Vaccine Trials

By Juliet Hulse

Senior Director of Global Research Nurse Strategy and Patient Advocacy

Illingworth Research Group

Clinical evaluation of a preventative vaccine typically requires large, lengthy trials. With the emergence of COVID-19, vaccine developers have been under intense pressure to bring effective vaccines to market within months, rather than years. Evaluating the safety and efficacy of such vaccines requires large trials involving healthy volunteers. In the setting of a public health emergency, where time is of the essence, rapid recruitment of a diverse study population is critical. The urgent need for generating high-quality data on an accelerated timeline also underscores the importance of ensuring subject compliance and reducing drop out rates.

Throughout the pandemic, there has been great demand for nurses trained in Good Clinical Practice (GCP) to help meet the substantial resourcing needs of vaccine trials involving tens of thousands of participants. As extensions of site investigative teams, mobile research nurses can assist with every step of a vaccine study—from recruitment and screening to enrollment, participant education, vaccine administration, and off-site visits.

Leveraging Mobile Research Nurses as an Extension of the Site Team

During times when study participants are unwilling or unable to travel to research centers, integrating experienced mobile research nurses into site investigative teams makes it possible to operationalize studies that might otherwise come to a halt. Instead of on-site visits, a skilled nurse travels to a study participant’s home or other convenient location to conduct visits and perform study-related activities, assessments and data collection.

The mobile research nursing team manages all the requirements of the visit, from coordinating with the pharmacy and the courier for delivery of the investigational product (if required) to bringing any necessary equipment or supplies and transferring any samples for delivery to a lab. In addition to allowing trials to move forward, these off-site visits ease both site and participant burden. They can also contribute to increased retention and participant engagement.

In vaccine trials where broad efficacy is a key objective, diversity of the study population is important. By reducing or eliminating the need for travel, mobile research nursing can help increase access to these studies and expand both the size and the diversity of the recruitment pool.

Using Pop-up Clinics to Support Recruitment

Recruitment of large numbers of healthy volunteers is a significant challenge of vaccine trials. Mobile research nurses can be used to staff recruitment and screening centers, either as an adjunct to trial sites or as fully independent pop-up clinics. Suitable locations for these off-site recruitment centers include private physiotherapy rooms, beauty salons, and community centers. Criteria used for selecting appropriate pop-up clinics include locations with easy transportation options, private facilities, waiting room areas, parking, and pleasant surroundings.

Case Study: Proof-of-Concept for the Value of Pop-up Clinics

A leading global diagnostics company engaged a contract research organization (CRO) to assist in enrolling at least 600 volunteers to test a new, rapid diagnostic on an aggressive study timeline. To meet this challenge, the CRO:

• Identified suitable locations, set up 14 pop-up clinics, and staffed them with mobile research nurses.
• Worked with a marketing company to launch a multi-channel advertising campaign, including social media.
• Allocated its Director of Research Nursing to serve as the Principal Investigator, responsible for overseeing all nursing activities and ensuring data cleaning was conducted on an ongoing basis.

From the time the first volunteer was enrolled, it took only 77 days to complete enrollment of 920 study subjects.

Although the volume of data per subject was not large – as is often seen in vaccine trials – the overall size of the study combined with the speed of enrollment meant that data management needed to be well-organized, with a constant flow of quality-controlled data to the sponsor. The mobile research nurses also performed the follow-up required to close out the study. The product received marketing approval two months later.

Providing Participant Education

Education is also a critical component of trials where participants are randomized to either placebo or experimental vaccine. As an example, a nursing researcher recently published an article on her experience as a participant in a COVID-19 vaccine trial. Even with her background as a nurse and researcher, she described how strange it felt to be a study participant and how disconcerting it was to be randomized and not know what injection she had received. Despite the extensive information she had on the clinical trial process and the vaccine, she also felt unprepared for the reactogenic adverse effects she had.[1] Her experience highlights potential barriers to recruitment or retention and areas of education where mobile research nurses can help fill the gap for under-resourced sites.

Utilizing Medical Imaging to Assess Safety

Advances in technology have expanded the breadth of procedures that can be performed off-site or in the home. In vaccine trials, injection site reactions are common side effects. Mobile research nurses can be trained by a professional medical imaging team to take photographs of vaccine administration sites during their engagement with participants. Mobile research nursing deployments also enable site staff to assess safety at more predictable or frequent timepoints which might not otherwise be possible if on-site visits were required.

Selecting a Mobile Research Nursing Provider

When evaluating mobile research nursing providers for a vaccine trial, developers may find it helpful to ask the following questions:

1. How are nurses selected?

Look for providers who offer experienced registered nurses that can serve all the geographies where the study will be conducted. Mobile research nurses supporting vaccine trials must be experienced in working autonomously on clinical trials in the home, school or workplace. Depending on the proposed labeling requirements for the vaccine, these nurses may also require experience with different pediatric populations and familiarity with taking blood samples and administering investigational product to children of all age groups.

2. How are nurses integrated with site staff?
   Since these nurses will be performing activities on behalf of the site, it is important to outline an on-boarding process that establishes the foundation for strong relationships with site staff. It is also critical to establish a consistent communication flow between site staff and the mobile research nurses throughout the study.
3. How are nurses trained?

The mobile research nursing provider should have a rigorous process for training nurses to conduct the assessments specified in the protocol in an off-site setting.

Importantly, the provider should also be able to demonstrate a high level of nurse oversight in order to ensure data quality, which is fundamental to clinical trial success.

Conclusion

Vaccine trials are resource-intensive, costly endeavors, especially when conducted in times of duress. Mobile research nursing is an agile, flexible option for meeting staffing needs, accelerating recruitment, facilitating more diverse subject participation, and reducing both site and participant burden, while improving the overall clinical trial experience for all stakeholders.

[1] Choi KR. A nursing researcher’s experience in a COVID-19 vaccine trial. JAMA Intern Med. 2021;181(2):157-158.