With the emergence of basket trials in the early-phase oncology setting, clinical research teams are…
Data from the Journal of Clinical Oncology suggests that the average U.S. site start-up time is approximately 36 weeks**. In comparison, sponsor data presented in 2011 at the Ontario Institute of Cancer Research Industry Collaboration Meeting concluded that the average site start-up time at a Canadian academic site is approximately 50 weeks*.
Scimega’s Reverse Feasibility Program is a novel approach designed to reverse this trend.
It is based on the premise that engaging study champions is critical to the overall success of any trial. With 48% of all trials missing enrollment targets (according to the latest report from the Tufts Center for the Study of Drug Development) it is also clear that sites with study champions are far more likely to accelerate the start-up process and meet recruitment objectives than those without.
Reverse Feasibility consists of matching the interests and study needs of a network of investigators with sponsors’ needs for study placement. It works from the bottom up, giving investigators the opportunity to participate in cutting-edge studies of interest, while providing patients with access to novel clinical trials.
The table below compares benchmark metrics from various regions and shows the power of the Reverse Feasibility approach. As you can see, the average site start-up time is reduced by over 50% compared to the U.S. average.
In the Phase I & II setting, Canadian sites, located in densely populated cities, typically out-recruit U.S. sites by a margin of 3-to-1 . This means fewer sites are typically needed to recruit the same number of patients.
With the average cost per site at approximately $100,000, reducing the number of sites leads to substantial cost savings.
The most important benefit to sponsors is having access to a pre-qualified network of highly motivated oncologists. This means you can expect an immediate, accurate assessment of your protocol. Knowing what to expect helps you make better drug development decisions.
Check out this informative Quick Reference Guide for tips and strategies on how you can reduce the number of sites you need, accelerate your site start-up times by up to 50%, and at the same time enhance your patient recruitment. On top of that, you may also find out that you qualify to save up to 30% on your professional service fees.
If you like what you read about what’s being done to disrupt the status quo and improve the process then please share it with colleagues who you feel would also benefit.
Please let us know what you and your company are doing to stay ahead of the curve and beat competitors to market that may be bigger and better funded than you. It’s time for us all to collaborate and think differently.