Facilitating a Large-scale Global Study on Amyotrophic Lateral Sclerosis (ALS)

The Challenge

mdgroup is currently supporting a global study on the rare disease Amyotropic Lateral Sclerosis (ALS), a nervous system disease that affects nerve cells in the brain and spinal cord. We were contracted to provide decentralized clinical services, as well as participant travel, where visits took place at the sites. We started supporting patients in 2022, and the study will continue until 2027.

The sheer size and global nature of this study came with its own set of challenges. The study took place in 15 countries, with documents required to be created and maintained in 17 languages. Many participants were in remote locations, creating additional challenges for mobile health and travel teams.

The high number of patients and visit frequency meant our team has been managing and completing up to 250 mobile health visits a month, and up to 20 per day around the globe. This has all been possible thanks to our global team, supporting patients from each respective region.

This also required a huge amount of collaboration and organisation to ensure that we had the right healthcare professionals and required equipment and other supplies, in the right place, at the right time, to support mobile health visits.

Due to the large scale of this study and its global reach, the CRO on the project required additional support with administrative duties and detailed reporting to meet not only client expectations but also all of the site’s expectations. This involved executing complicated site agreements, creating individualized site templates, and being flexible overall with our processes to ensure site and client documentation were complete and up to date.

 

The Solution

The client was keen to make the study as accessible for participants as possible. Due to the nature of this disease, which impacts patient mobility, the client wanted to ease the burden for participants and partnered with mdgroup to support patients, whether study visits were taking place at the site or at a remote location. Mobile health (MH) was built into this protocol as an option for patients where it was safe and effective to do so. This, along with a tailored, white glove travel service for when participants elected to or were required to visit the site, remained a priority throughout, as many participants resided in remote locations.

The nature of the disease meant that communication was going to be a challenge at times due to slurred speech or difficulty texting. Our patient navigators, paying particular attention to participants’ preferences and requirements, were key to ensuring we could always provide a service tailored to their individual needs.

Having our in-house HCP resourcing agency and clinical equipment supply divisions fully integrated into the project team ensured we were able to meet the needs for visits, sometimes at short notice. Having resourcing and equipment managed internally and not through a third party, along with close relationships with couriers for samples and supply logistics, has been crucial on such a high-volume study. Our in-house systems, tailored to the specifics of our services, enabled us to plan, schedule, and manage all mobile health visits, which has been vital in a study of such scale.

Communication amongst the global internal team has been a vital asset to working through the day-to-day challenges presented by this project. The team’s flexibility, dedication, and high professionalism have been key in managing a project of this scale. Communication with the client was managed with weekly calls with the client and CRO, as well as frequent email communications with the client, CRAs, PM, and CTMs. Clear expectations were often realigned, and a CRA retraining of our services was offered to CRO approximately one year into the project for newly onboarded CRAs, and it became a requirement.

Of particular note, we had one site in Poland with a large participant volume. The site was reluctant to offer mobile health visit services to its patients. With support from the client, we arranged calls to understand and address the site’s concerns with this service. As part of our site engagement services, we provided thorough retraining that was specifically tailored to address the site’s concerns. Additionally, we implemented weekly phone calls with the study coordinator to review their active participants due to their large participant volume. Individual emails regarding each subject were getting confusing, and we listened to their concerns, consolidated requests, and provided better explanations for the study coordinator to help her understand where our requests are coming from. We worked with the site to improve their efficiency in submitting forms and clarifying reimbursements.

Overall, the site is very satisfied with our services, which are significantly reducing the burden on the site staff. They currently have 30+ active participants, and we have conducted over 100 mobile health visits for this site alone.

 

The Outcome

The decentralised clinical team successfully collaborated with a large internal and external team, leading to successful service delivery for all stakeholders involved in the study and vital quality data output from visits. This study team has so far completed over 1000 successful mobile health visits, reimbursements, and travel in 15 countries, along with the translation of patient-facing documents into 17 languages. HCP turnover has been low overall, and in most cases, we have been able to use the same healthcare professional for all visits for a given participant – helping to build trust, confidence, and continuity of care.

We are incredibly proud that all participants have received reimbursements in a very timely manner for such a long-term study and had a positive experience of our services overall. The client was happy with our flexibility throughout the study in handling multiple protocol amendments at short notice and organising urgent unscheduled visits. This close collaboration and our ability to flex have resulted in the client being very satisfied with our services.

Participants and sites have been very happy with the smooth delivery of our patient services. Fewer mobile patients were able to participate in and remain on the study for a greater period of time. Patient retention in clinical trials is one of the largest challenges facing sites, sponsors, and CROs. The Center for Information and Study on Clinical Research Participation found that 23% of participants who enrol in a study don’t complete it. In this study, due to thoughtful planning by the client in the design and set-up of the study, the burden of participation was reduced, enrolment was completed ahead of schedule, and the dropout rate was significantly lower than the industry average at 12%, thus reducing the overall duration and cost of the study.

 

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