OR WAIT 15 SECS
Now that I have your attention, I’d like all the football and non-football fans to take a moment to share your views on current clinical study challenges.
In September, our sister conference company, CBI, is hosting its Forum on Phase II-III Clinical Study Optimization. There is an excellent line-up of speakers sharing their own strategies for tackling some of those challenges. The topics span all aspects of clinical trials that are vexing professionals today—study planning; budgeting and forecasting for improved cost analysis; study design and protocol development considerations to optimize Phase II-III research; patient recruitment, retention and enrollment; site selection; CRO selection; and risk-based monitoring.
The survey incorporates these topics and draws on your experiences to then set the stage for some of the solutions that will be offered.
For example, currently the survey results are reporting that 25% of the respondents outsource monitoring as a specific function. With FDA guidance released last year on approaches to risk-based monitoring, and a reflection paper from the EMA, Vadim Tantsyura, Manager, Clinical Trial Operations for Sanofi, will present the latest on to Risk-Based Approaches to Clinical Monitoring and offer help to identify factors to consider in developing a monitoring plan.
From the series of questions on protocol and trial design, in addition to showing the survey results, the discussion at the Forum will focus around increases in trial design and protocol complexity, some of which we have covered in Applied Clinical Trials. Eriene Wasef, PharmD, Senior Associate Clinical Director at Hoffmann-La Roche, will discuss the need and solutions to identify potential challenges and develop a detailed and comprehensive protocol, which has become very crucial in drug trials today.
I didn’t leave a blank space in the survey to ask everyone what their favorite football team is. But the conference will be in Chicago, Home of the Bears. Thanks again for taking the survey, we will offer some perspectives on the conference and the survey online.