Clinical Trial Rescue Support
Every clinical study has unique challenges that may not have been factored in initially
BBCR’s experienced management team can help sponsors solve lengthy trial timelines and improve data quality.
Rare Diseases and Precision Medicine require unique trial execution for quality data.
A study most often needs rescuing when:
- In danger of being completed in a timely manner
- Data quality is at risk
- Regulatory agency trial has been discontinued
- Efficacy endpoint is missed
- Unable to demonstrate value compared to existing therapy
Rescue may be as simple as adding third-party experts to the sponsor’s team, risk analysis, management aid, and CRO oversight.
BBCR’s experienced management addresses risks such as:
- Delayed enrollment
- Multiple protocol amendments
- Poor patient retention
- Poor data quality
- Prolonged trial completion timeline
- Poor safety monitor
In any failed trial, there can be many potential culprits. Sometimes these failures are unavoidable, but many times the solution exists.
Trial rescue saves years of work and the opportunity to treat patients.
Case Study
Savage rare disease trial
Challenge: Phase 3 in a rare infectious disease enrolled only 10% of patients in twelve months. The Sponsor had to decide to either change the CRO or close the trial.
Solution: A gap analysis of the multiple recruitment tools and the numerous opened sites was conducted. The website base recruitment tool showed the inability to connect patients with sites on time. Site interviews showed that two third of the opened sites either had no direct access to patients or referral networks.
Result: A decision was made to keep the CRO. The website base recruitment tool was closed as it was too expensive and inefficient.
Many sites were closed due to a flawed recruitment system. Sites were motivated and supported via active ongoing interactions. During the pandemic year of 2022, recruitment was completed. The study drug showed efficacy and safety. Patients will have access to effective therapy.