Faster, better, cheaper clinical trials have remained elusive despite years of experience and the growing use of technology. The time appears right for a new type of collaboration.
The concept is simple: A regional consortium of academic and private community clinical sites adopts a shared clinical trials platform, as well as standardized processes, to achieve economies of scale. The consortium offers one-stop shopping for sponsors with a single point of contact. With one legal contract, one trial budget, one institutional review board (IRB), and one integrated IT platform, these features could yield dramatic improvements to the speed, quality, and cost of trials.
This model has many advantages. Instead of a study sponsor negotiating with five trial entities, it would negotiate with one. With a standard contract and budget, negotiations could be done in weeks instead of months. With a single, centralized, focused IRB, the IRB could be held to high standards for quick decision turnaround and competitive fees.
In our experience, recruiting from deep within the local community practices, patient accrual rates have increased from 20 percent to 60 percent per study.
The integration of standard operating procedures (SOPs), processes, and technology could help to ensure an optimized platform that delivers real-time, high-quality data to the study sponsors. Common SOPs would allow sites to focus on science, safety, and quality — not process.
EntraLogix Clinical Group Inc. has demonstrated on a number of Dermatology, Nephrology and Orthopedic Surgery pivotal Industry Sponsored Phase III studies that this model works. The benefits are real.