Case Study: Multiple Sclerosis Longitudinal Study
A boutique CRO was unsuccessful at sourcing PBMCs via their academic clinical collaborator for a Multiple Sclerosis (MS) longitudinal study involving 6 MS subjects and 6 age-, sex- and ethnicity-matched controls. Finding themselves in this unfortunate situation, they quickly turned to alternative sources. Recruitment was foremost limited by the low prevalence of MS (400,000 subjects in the US), and furthermore complicated by exclusion criteria based on a custom questionnaire, current medication, and subtype of MS.
The client also required a special collection protocol, same-day delivery within 4 hours of collection for processing, and 2 redraws every 2 weeks. Taken together, the CRO was unable to identify any other commercial vendors capable of enrolling qualified patients, and executing the project according to their special collection protocol, delivery schedule, and timeline.
This project was no match for Sanguine's crowdsourcing and in-home collection model. Sanguine eagerly accepted the contract and within hours developed a recruiting strategy focused on online advertising which received an overwhelming response of over 100 willing participants, thereby easily recruiting the required 12 study participants in under 1 week. Sanguine quickly administered the custom questionnaire to identify qualified study participants, and collections were promptly scheduled and performed according to the CRO's special protocol using Sanguine's mobile phlebotomy network.
Delivery of the specimen by phlebotomists within 4 hours of in-home collection was coordinated with the laboratory to ensure timely processing. Ultimately, even with all the caveats in recruitment, enrollment, and multiple draws, collections for all 12 study participants was completed in just 6 short weeks, far in advance of the sponsor's deadline!
Successfully recruited over 1OO willing participants
Performed first draws on 6 MS and 6 matched controls
Performed second draws
Performed third draw and completed collection
Custom questionnaire executed for participant selection
Exclusions based on medications and disease subtype
Special collection and processing protocol
Same-day delivery within 4 hours of collection