The Food and Drug Administration (FDA) has started encouraging the use of adaptive designs for clinical studies. In essence, adaptive designs allow prospectively planned modifications to a clinical trial based on interim data, provided scientific validity (the ability to draw sound inferences) and data integrity (credibility and reproducibility) are preserved.
Understanding Why Creative Solutions Are Necessary
With last month’s celebration of Rare Disease Month and specifically, Rare Disease Day, awareness of the research challenges faced by patients and pharma companies are especially high during this season.
November 17, 2017
A Recap of the New York Medidata NEXT Event: Where Science Meets Technology Meets the Future
Kathleen Boruchowski, Associate Director of Data Management, attended the Medidata NEXTconference in New York City on November 8-10. The conference, which has many global locations throughout the year, offered Medidata’s customers a front row seat to learn how data, insights, and technology are transforming the clinical trials industry and ultimately accelerating the hope for patients desperately seeking new treatment options.
October 3, 2017
In pharmaceutical clinical trials, considering competing risk analyses is highly important. Competing risks are events that may occur and prevent the evaluation of a specific primary endpoint, in turn biasing risk estimations or drug efficacy.
August 15, 2017
To Improve Real-Time Visibility of Clinical Trial Documentation and Inspection-Readiness
Veristat has completed the validation and configuration of Master Control’s eTMF system, which is now implemented and available for Veristat managed clinical trials.
Just last week, in the midst of the daily chaos of building new clinical trial databases, working on impending regulatory submissions, holding project team meetings, and programing tables figures & listings, Veristat paused its operations for one day in order to reflect upon and celebrate its contributions to drug development.
At the 2016 Duke Industry Statistics Symposium, Dr. Robin Bliss, in collaboration with Dr. Jing Wang of Gilead Sciences, lead a discussion on “Biomarker-Driven Clinical Trial Designs for Precision Medicine.” Dr. Bliss highlighted two Adaptive Enrichment Clinical Trials performed by Veristat as case studies for how to select and execute an enrichment clinical trial design.
An adaptive design is a clinical trial design that allows adaptations or modifications to aspects of the trial after its initiation without undermining the validity and integrity of the trial. An adaptive design consists of multiple stages. At each stage, data analyses are conducted and adaptations take place based on updated information to maximize the probability of success of a trial.