Author: MRN
When it comes to decentralized/hybrid trials it’s almost impossible to have a one fits all – sponsors, CROs, sites and patients, each have their own unique set of needs….and challenges. MRN’s Home Trial Support (HTS) is a flexible solution – and one often opted for by sponsor and patients alike as it has the potential to help drive enrollment while increasing engagement and retention…for patients this translates to more flexibility when it comes to both when and where their visits can take place. This all sounds great for sponsors and patients, but how does it benefit sites? And, as we mentioned, there is no one size fits all, so how do you get the optimal result needed for patients and sponsors, as well as sites
Sites and HTS go hand-in-hand. Home Trial Support has been around for almost 2 decades and has proven to increase recruitment and improve retention, but positive results really only come when there is buy-in from all stakeholders. Without site buy-in it becomes increasingly difficult to address, support and fill recruitment and retention gaps sites may have or even proceed with conducting the home visits. We know that if there is a lack of education, support and collaboration with the site, it is difficult to accelerate enrollment and, in turn, trial timelines.
Site-level engagement and communication with MRN can help build trust between remote and on-site teams. MRN ensures that our in-country team speaks the local language and has a full understanding of the local regulations – allowing productive dialogue and engagement with sites.
Support goes both ways and MRN has a dedicated Site Relationship team that works directly with sites to ensure that the HTS solution is one that not only provides support for the patients and the trial, but also for the sites running the study. The important thing here is focus on the key concept – this is meant to be solution, not some enrollment tactic that will leave sites to carry additional workloads to see it through. Quite the opposite in fact – HTS should alleviate a number of site burdens. These can include and are not limited to:
- Patient Management
- This ranges from organizing or rescheduling to general management of patient visits.
- Patient care
- This is not limited carrying out protocol – our Home healthcare professionals (HCPs) will be able to observe the patient in their home environment and provide feedback to the study team/ primary care physician if additional support is required or safety measures need to be taken for that patient.
- Tech for sites
- MRN provides sites with access to its fully validated and regulatory-approved eClinical platform. Allowing them to review electronic report forms (eVRFs) immediately after the in-home visit.
MRN’s own data, from previously supported programs, has shown we can deliver increased recruitment at sites when we have early and direct communication with site teams, over those that we do not have opportunity to engage with. When we have early site engagement and direct communication, we can support sites appropriately to minimize their burden while speeding up their trial timelines.
When more than one solution is needed. We fully understand that each study will (and should!) require a strategy that is unique to it. Sometimes this requires more than one site supporting solution – especially when it comes to those studies that require patients traveling to site for most of the trial visits.
So why would that need a decentralized/hybrid solution? Well not all patients live close enough to site where their daily life won’t be heavily disrupted…and not all sites have the capability to give the study and time it needs to enroll and retain these patients. Additionally, it is unlikely that without a decentralized/hybrid solution, the study will enroll a broad a diverse patient population – something the FDA and other medical regulatory agencies now insist upon for study data to be deemed representative.
The solution? Bring the sites to the patients! MRN’s global Site Network can do this, with a mix of experienced, virtual, trial-naïve and even community pop-up sites, which are all supported by MRN. These sites are able to reach more patients no matter where they live, ensuring diversity in data while providing healthcare options to patients in these communities.
All sites within MRN’s Site Network have access to MRN support – and when needed, access to MRN solutions, such as HTS and Site Professional Support, a solution that can resource sites around the globe. The combination of solutions can offer patients maximum flexibility and sites maximum support. When patients need to attend a site for a visit, they will have one local to them, and when there is no requirement for a site visit, an HTS HCP can visit the patient at home. By offering such flexibility, more patients are likely to enroll and remain engaged throughout the length of the trial.
MRN has been an industry leader for over 18 years, constantly developing, perfecting and innovating decentralized/hybrid solutions that offer new ways of delivering critical solutions that allow patients of all ages, and all walks of life access to critical healthcare through clinical trials, while supporting sites and increasing ROI for sponsors. Innovation breeds success – and positive outcomes for all – for sponsors, patients, and sites.