The VALOR study sought to enroll patients with amyotrophic lateral sclerosis (ALS) who had a mutation in the superoxide dismutase type 1 (SOD1) gene.
Because patients may not have known whether they had the mutation, genetic testing was included as part of the eligibility screening.
A global study, with an estimated 35,000 individuals living with ALS just in the United States and the United Kingdom alone, the opportunity resonated with a large percentage of the patient population interested in genetic testing.
Only about 2% of ALS patients have a mutation in the SOD1 gene.
Patients are burdened by having to travel to and from study appointments.
Patients are concerned about the possibility of being randomized to the placebo group.
BBK developed materials to keep the study top of mind at global study sites and to support patient identification and consent. Our patient and referring-physician materials were informed and approachable. They helped staff to quickly identify potentially eligible patients against key criteria while also providing patients and caregivers with the information necessary to foster consent.
We strategized to maintain a brand consistency that would resonate across multiple studies within the sponsor’s ALS pipeline.
BBK used a detailed prescreening process designed to rank and identify potential participants based on their knowledge of their condition, including ALS diagnosis history, SOD1 testing status, history of familial ALS and willingness to participate in clinical research. As a result, over 1,700 highly qualified referrals were generated, identified and sent along to sites for additional follow-up.
BBK supported study engagement by providing travel and reimbursement services so that patients could be reimbursed immediately anywhere in the world. BBK’s concierge travel support arranged services like in-country and cross-border travel for patients and their caregivers or legally authorized representatives and providing hospital beds to patients during their travel.
Site: Île-de-France, France
A patient in France required an ambulance transport to and from study visits as their condition progressed.
Site: Quebec, Canada
The Concierge team worked extensively over a number of visits to assist the patient and caregiver as the patient's mobility declined throughout their study participation. Support included:
Hospital Bed Rental
Site: Florida, United States
A member of the site staff in the US requested assistance from BBK’s Concierge specialists to help source a hospital bed that could be rented for one of their patients.
To establish the sponsor as a sponsor of choice in the ALS treatment space, we supported their pipeline of related studies with branding and material development. Because the other studies were phase 1, those programs were given study logos but remained identified by protocol number as opposed to a study name. Their logos differentiated each individual study while maintaining a strong brand consistency and presence across all study materials.
Download the PDF version of this case study today: