Learn how we improved recruitment and retention for a Phase I/II study in spinal cord trauma patients.

1. PARTNERING WITH
STAKEHOLDERS TO DRIVE
A SUCCESSFUL PHASE I/II
SPINAL CORD INJURY STUDY
Case Study
In the case study below, we outline key challenges and achievements from a recently completed Phase
I/II study in spinal cord trauma patients.
Background
An early Phase I/II study in patients with severe (acute Thoracic – T2-T11) spinal cord trauma with
surgical stem cells transplantation.
Challenges
▶ Very restrictive inclusion criteria related to the type of injury and stem cells transplantation, narrowing
the pool of potential participants
▶ Complex assessments requiring centralized approach for study conduct, limiting the number of sites
▶ Introduction of new neurophysiological tests; no standardized method for evaluation of measurements
▶ Patients’ reported outcomes required caregiver support for this patient population
Actions
▶ Developed strategy for networking with key opinion leaders (KOLs) in different regions to get them
engaged and to provide support to patients referred to the study sites
▶ Selected two spinal cord injury specialized sites in strategic locations to facilitate the movement of
patients during the study
▶ Worked closely with the sites’ personnel, sponsor and KOL to develop harmonized evaluation criteria
▶ Developed patient-friendly environment, freeing caregivers of travel related burdens, to keep family
members involved and to help with the study participation
▶ Extensive medical and operational collaboration to support study delivery
Results
▶ Patients from five countries were enrolled at two sites in two strategic locations. The Covance team
worked closely with sponsor, local Authorities, and Ethics Committee (EC) and Institutional Review Board
(IRB) to develop full scope of documents and processes (e.g. multilingual informed consent form (ICF),
multilingual sites’ staff, travel compensation and arrangements) to support participation of patients from
other countries.

2. ▶ Not a single patient dropped out during the course of the study (over 12-month study duration).
▶ Achieved last patient in, database lock and topline results, with all data collected and finalized as
planned.
Successful Outcomes
The Covance team applied innovative and collaborative approaches in working with all stakeholders, including
the sponsor and investigators on this challenging trial. The team was able to leverage processes and tools scaled
for early clinical studies, best practices and a true partnership with the client resulting in successful completion
of the study.
To learn more about how Covance can help you meet the challenges in
developing neuroscience therapies and delivering them to market quickly
and cost effectively, please contact us at www.covance.com/neuroscience.
Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory
Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the marketing
name for Covance Inc. and its subsidiaries around the world.
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