Harness the power of real-world evidence to optimize investigator selection and accelerate patient recruitment in this issue of Consultant Connection.

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Real-World Evidence – A New Way to Deliver High-Performing Investigators and Faster Patient Enrollment

Are your client’s clinical trials getting delayed from identifying, recruiting and enrolling the right investigators and patients? Well, they’re not alone. With today’s more complex studies, finding and attracting eligible patients and identifying better performing investigator sites are industry-wide challenges that impact the time and cost of drug development.

With real-world evidence, you have a multi-faceted approach that elevates your client’s clinical trial and speeds investigator and patient processes:
  • Identify optimal sites. Your client’s study can’t risk enlisting under-performing sites that fail to meet enrollment targets. With access to historical performance data on 175,000 investigators across 16,000 protocols within Xcellerate®, you will increase the likelihood for your client’s success. Imagine scoring sites on the following key parameters – number of patients enrolled, date of first-patient-in and quality scores for cancellations and queries. With historical data at your fingertips, you will readily identify investigators who consistently outperform their peers.   
  • Pinpoint patient densities. Enable your clients to locate investigators with high patient densities – as well as potential areas for referrals or new sites. With access to de-identified patient data, including 11 billion LabCorp laboratory test results, planning teams plot trends in patient densities, view testing locations and pinpoint high-performing investigators. 
  • Pressure-test clinical protocols. Protocol design decisions may impact your client’s ability to enroll patients in their studies. Optimize protocols, minimize risk and improve outcomes with real-world data from more than 16,000 clinical protocols across most indications. “Pressure-testing” your client’s protocol can help them simplify the design so enrollment targets can be met.  
With the right combination of real-world data and powerful analytics tools, you can suggest unique, data-driven approaches that empower your client to enhance their clinical trials so they’re ready for success right from the start. 

Increasing Enrollment Performance – 
A Case Study
A sponsor needed to enroll 11,000 patients at high risk for cardiovascular events in a Phase III trial for lipid modification. The client estimated it needed to enlist 750 sites, but by querying the Covance global clinical trial knowledgebase, 550 vetted sites with known investigator performance metrics were identified. By reducing the number of sites, the client engaged the highest performing investigators, met their target and experienced a dramatic reduction in overall cost. 

In addition, the sites were strategically set up with central IRBs, which helped decrease study start up time and achieved first-patient-in three months earlier than planned. With the combination of proprietary data and early preparation with the consultant, the client completed enrollment seven months ahead of schedule. 

Start Optimizing Your Next Trial Design Today
Lecia Johnson and her team will provide you with seamless access to Covance solutions – preclinical through clinical, to registration and market access.