Complex TBI Study Rescue: Creative Problem-Solving and Rapid Implementation of Strategy Boost Patient Enrollment and Engagement

Spotlight on TBI

Traumatic brain injury (TBI) is estimated to affect up to 69 million people per year worldwide. While, at one time, TBIs resulted in disability and death, innovations in diagnosis and treatment during the 20th century have led to improved outcomes for patients.

Study Challenges

Biorasi was invited to provide a two-part clinical study rescue for a leading biotechnology research company. The study was focused on Phase II of a stem cell therapy treatment for TBI. The sponsor was experiencing obstacles to study enrollment, site, and patient engagement despite having started the project two years prior.

Due to the difficult nature of the study, the sponsor had employed a patient registry to identify potential patients and route them to participating study sites. While the registry was able to identify potential participants for the study, the patient journey from identification to screening was off course. Patients who were identified for the study did not receive proper guidance or follow-up and were unable able to reach sites for screening assessment. The main challenges were:

• Patients receiving unsolicited packages from the patient registry, not knowing what actions to take.
• Patients calling clinical sites for information, however some sites had not yet been activated and were not responding the patients.
• Patient contact information becoming lost or not followed up by the sites.
• Patients who met study criteria becoming disinterested due to follow up inactivity.

The result led to only five patients being recruited over two years, significantly delaying the expected completion of the study. There were also other challenges for Biorasi to address:

• The study included a complex surgical procedure as part of the protocol which required strong procedures for blind maintenance and a lot of coordination between main and surgical sites.
• The introduction of a variability factor due to subjective rating scales across clinical sites.
• The sponsor’s hesitance in integrating a new CRO into the current study to assist after so much time, effort, and budget had been invested in the incumbent CRO.

Creative Solutions

The Biorasi Operations Team were first brought in to support the patient identification to screening journey, with a creative solution to reinvigorating enrollment and engagement as well as connecting interested patients with sites. After coordinating with the incumbent CRO and assuming responsibility of the study, Biorasi initiated the following steps:

• Facilitated participation and “matchmaking” between potential patients and clinical sites.
• Followed up with potential patients after screening visits.
• Coordinated patient travel and site logistics.
• Improved patient motivation and experience among potential patients and renewed interest in the study.

While Biorasi’s integration into the study boosted screening and enrollment, the sponsor noted that recruitment was still behind schedule, several sites were still pending activation, and active sites were demotivated and disengaged. Impressed with Biorasi’s quick ability to activate and implement creative solutions, the sponsor asked Biorasi to assume full control of the study.

Once awarded the full study rescue, Biorasi was able to reassess recruitment and clinical site selection, site activation, and existing site challenges. This assessment resulted in a major revision to the study strategy, which provided a much-needed boost to enrollment. Biorasi’s strategy included:

• Identifying additional TBI patient advocacy groups and patient registries to increase the pool of potential patients.
• Adding a vendor management role to ensure third-party efficiency, leading to a more efficient coordination of study logistics and study compliance.
• Adding a central eligibility confirmation role to the study to support and validate the patient screening process.
• Assessing currently active sites in the United States, which involved adding new sites and closing those that were underperforming.
• Running booster visits in the United States to re-connect with sites, promote enrollment, and revive interest in the study.
• Identifying a new venue and activating new sites in new locations across Eastern Europe and APAC.
• Qualifying new global partners and vendors to support the study, inclusive of raters assessing patient progress.
• Incentivizing local physician networks to encourage recommendations for potential patients.

Successful Results

Biorasi’s prior experience with trial rescues allowed for a quick and organized transition, and we were able to meet the sponsor’s original timeline, enrolling the remaining 56 patients in 12-months’ time. Patients became reengaged, and the trial saw an immediate increase in the number of screenings – overrecruiting by about 10% – and boosting retention.

Biorasi successfully completed the Phase II trial on time and on budget with:

• 61 patients enrolled.
• One new venue added that contributed 10 patients via a single site.
• 37 total sites activated.
• 9 additional subjects enrolled over the estimated patient population per protocol.