Evaluation of key performance indicators in the clinical research setting
By Kathryn E. Vinson, MS, CCRC
It has been said countless times in history that timing is everything. That phrase holds particular interest in the world of clinical research, wherein a difference of a day in reporting can mean the difference between being the first and being old news. Let’s face it, in the world of pharmaceutical and drug development – being first is important – but it’s not everything. Volunteer safety and quality data are still paramount. Today, here at DZS Clinical Services we would like to discuss cycle times and other vital key performance indicators to help you in your CRO partnership decisions.
At the basis of all the trials that are conducted, it comes down to quality data – and the integrity of that data is a direct result of our adherence to the protocol and data management plans as set forth before the trial begins. So, how are sponsors and research sites supposed to meet the often incredibly tight timelines dictated by not only the market but also regulatory authorities? The answer is surprisingly simple. By partnering with the best.
Rapid Study Start-Up
As we discussed recently in “Ready, Set, Go!” the ability to hit the ground running on a trial can be vital in many cases. But speed isn’t everything – quality still matters. DZS has processes in place that can drastically reduce the cycle times of pre-study meetings, recruitment, and time to first randomization, all while maintaining the utmost quality and safety standards.
Accrual Rates and Protocol Deviations
Once the start-up meetings have concluded, it is time to recruit. We all know that you don’t have a study if you can’t recruit qualified volunteers. While clinical protocols have strict inclusion/exclusion criteria, many sponsors are often placed in a position of approving waivers for volunteers perhaps missing a criterion by a small amount, or the data is deemed “not clinically significant” by the principal investigator (PI). These minor deviations happen all the time – but that doesn’t make it right. The possibility of these deviations having an effect on the trial outcome is always there.
As clinical researchers, it is our responsibility to recruit volunteers to our trials that are perfectly qualified in order to remove variables that could confound results. With our extensive knowledge of our partner sites’ abilities, the DZS project management team can help sponsors identify those sites with a proven track record of quality volunteer recruitment.
By partnering with DZS, you gain even more than our team with the knowledge to get your trial running quickly and efficiently. You also gain access to our DZS Insight Platform. With the DZS Insight Platform, you not only have access to streamlined data and KPIs, but also the ability to track data trends such as sites with excessive screen failures, protocol deviations, and SAEs.
We know that sponsors have a lot of choices when partnering with a CRO. Here at DZS, our team of seasoned research professionals is the bridge that sponsors and research sites alike need to realize tight timelines while maintaining study integrity. Let us be “Your Direct Line to Maximized Trial Efficiency.”