Newsletter | October 13, 2020

10.13.20 -- Can Your Clinical Data Strategy Keep Pace?

Novel Trial Approaches For Rare Cancer Patients

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers. This webinar explores the promise and challenges associated with the planning and execution of rare cancer trials.

Setting A Real-World Strategy In An Evolving Clinical Research Environment

Since early this year, many standard clinical trial processes have been significantly disrupted. Patients have been prevented from attending regular physician visits. Clinical research associates who traveled regularly to study sites to review and verify processes and data were unable to do so. Supply chain upheaval has forced schedule modifications and substitutions for products in short supply. This podcast discusses the need to change the way patients participate in trials and also how data is collected and monitored.

Can Your Clinical Data Strategy Keep Pace?

The clinical research environment has been impacted in multiple ways during the pandemic, ranging from new regulatory requirements to supply chain interruptions and shipping delays. In addition, many of the standard clinical trial logistics are being reassessed. Learn about the importance of process in ensuring a robust strategy is in place for the acquisition and analysis of trial data in the face of a changing clinical research environment.

Entering A New Clinical Phase Of Nontraditional Data Sources

Non-traditional data points, in particular real-world data (RWD) and real-world evidence (RWE), are becoming more and more important in the current research climate. The FDA and other regulators have started to embrace the use of real-world, unstructured data alongside traditional randomized control trial (RCT) data. This article covers nontraditional data points, their use in RCTs, and how they contribute to a successful data strategy.