Last month, Té Revesz, principal, GlobalReach-SBI, and host of GlobalReach: Winning in World Markets, invited BBK’s own Matt Kibby, principal, technology and innovation, on her radio show. The two discussed managing global clinical trials, challenges facing innovation, and why Big Data isn’t better in the world of patient recruitment. We had an opportunity to ask Té a few questions of our own. Here’s what she had to say…
Moneyball. It’s a gift that keeps on giving for me as a guy wrapped up in patient recruitment data. As an ex-patriot Brit, I must admit that it took me about 10 years to start to appreciate baseball, and it has taken another 10 to figure out just some of the intricacies. A seemingly simple game, it is filled with deeply meaningful and detailed subtexts, and perhaps it is not without irony then that the game lends itself so well to so many “sports-as-life” American metaphors.
This is hard for me to say and I bet most of my closest friends and colleagues will not believe that these words are coming from me, but here goes… “Change is good!” I am not sure why, but I have always had a hard time accepting change. If your childhood experiences shape you in this regard, then maybe the consistency and lack of change in my youth helps explain this. Born and raised in the same house, parents happily married after 55 years, watched my father go to work each day at the same job he held for most of his adult life…
Clinical trial performance reporting is a key element in running a cost-efficient patient recruitment program. How is enrollment going? What is the study’s current screen fail rate? Are sites overwhelmed with referrals? At BBK, these are all questions we review on a daily basis – and very often we can find the answers to these questions through reporting analysis. It’s a no-brainer that we depend heavily on reports from TrialCentralNet (TCN®) to make important and strategic decisions. With this in mind, we spend many of our days developing the most accurate and effective TCN reports, which has led to almost endless reporting capabilities. Here are some examples of BBK’s reporting analyses in which we base our recommendations and tactical responses:
Ready. Set. Go.® Arrive Streamlines Travel for Clinical Trial Study Visits
Having a streamlined and transparent strategy when looking at the enrollment performance of sites throughout a clinical study is vital to achieving on-time enrollment. Implementing a plan to mitigate enrollment barriers and how to deal with underperformance at sites are keys to gauging which sites are best fit to achieve set enrollment goals, and which sites need to be closed to enrollment.
This story is part of my ongoing effort to share with all of the young children in my life what I do at work as well as the importance of patient recruitment technology to the daily operations of a clinical study. So, sit on down crisscross-applesauce and get your listening ears ready because here’s what happens “If you Give a Site a TrialCentralNet℠...”
Each and every review of a draft protocol by a study team, legal department, medical group, or regulatory agency is a test. Throughout this process it is easy to lose sight of what may well be the ultimate test of all – just, what does a protocol mean to a potential patient?
Analyzing a protocol from a patient recruitment perspective is imperative. When completed early in the protocol development stage, it can mean the cost-efficient addition of “patient-friendly” components that can significantly impact on-time enrollment. Consider the feasibility of:
- Minimizing patient time at study visits;
- Giving access to disease specialists;
- Offering an open-label option; or
- Providing concomitant medications or therapies at no cost
Well, the first advertising run yielded some high results. And two weeks later, sites are still processing referrals at a high capacity. The preliminary analysis is in – you’ve planned, strategized, and implemented. But then, you see a lack of screening and randomization activity at one particular site and think, “What is this site not doing?” Factors start to set in. Metrics make it clearer. Something has changed.