How many data points are collected in the average clinical trial and how much is actually included in final trial reports? What can be done about the increasing complexity of clinical trials? Watch this quick video for answers to these questions and more.
Clinical Data Analytics
Getting effective treatments to patients more quickly is an industry goal and especially important within oncology studies. With the CDISC standardization of Study Data Tabulation Model (SDTM) structures for oncology studies and flexibility of EDC systems, it seems there would be a simple way to get data collected and easily reviewable to shorten study timelines.
Risk-Based Monitoring was all the buzz at the Society for Clinical Data Management (SCDM) 2013 conference in Chicago. The last day of the event kicked off with ~120 attendees at the 8:15am session, "The New Data Manager: Merging of Traditional Roles with Implementation of Risk-Based Monitoring," chaired by Candace Friend Shelton, director of clinical data sciences at Celerion. Dr. William Bill Gluck, VP at DATATRAK International and Stephen Young, senior product director at Medidata both spoke at this well-attended session, with Steve's presentation focusing on the implications of risk-based monitoring on data management.
Some queries are more equal than others! Those of you familiar with George Orwell’s “Animal Farm” may recognize this paradoxical declaration. The queries I refer to here are the "questions" sent back to investigative sites to clarify clinical data that they have provided to the sponsor during a research trial.
Geeks Talk Clinical contributor—often exhorts his fellow “Medidatians” to not simply work hard, but most importantly to work smart. While I’m sure he fully expects that we will continue to work with the same high level of passion as before, what he really wants is for us to seek out opportunities to increase the impact of our collective efforts.