Research sites are turning to various types of performance metrics to support risk-based management of clinical trials. “The first step in proactive data monitoring is to identify what is possible to mitigate, eliminate, and accept,” Hughes wrote. “This all forms part of various plans, including those for data, training, monitoring, statistical analysis, safety, medical monitoring, quality, and other functional plans.”
Patient enrollment is a common subject of discussion among both sponsors and research sites. Challenges to enrollment can be myriad, and the root causes are hard to pin down. But effective enrollment is critical to the ultimate success of any clinical trial, and there...
Protocol deviations can have a detrimental effect on new drug development, adding to costs and time to clinical trials and even putting the acceptability of data generated during a study at risk. Despite this, protocol deviations seem to be viewed as just part of...
Whether ensuring GCP compliance or the correct application of a study protocol, training is a critical part of any clinical trial. During the life of a study, there may be several points at which a sponsor may require additional or more intensive training to...
As a former CRA, I have spent the better part of my career mentoring, teaching, and helping CRAs become competent at monitoring clinical trials to ensure compliance with protocol and GCP. In light of this experience, I urge all CRAs and monitors to STOP THE MADNESS of...
Protocol deviations can have a devastating impact on the quality and integrity of key study data and potentially affect patient safety. And there can be serious regulatory repercussions for failing to follow the protocol precisely, as well. Taking the right approach...
Sponsors and CROs trying to achieve better enrollment in clinical trials often overlook the most essential stakeholder in the process — the investigative sites that implement the trials and interact with the patients throughout the process
Behavior Should Drive Clinical Trial Training, Not Test Scores Applying analytics that focus heavily on measuring changes to research staff behavior during training can be a strong predictor of performance during an active clinical trial, leading to better protocol...
As part of our series covering all the do's and don'ts surrounding protocols, I wanted to call attention to one of the greatest urban legends in clinical research...the requirement to include endless footnotes (in size 6 or 8 font no less!), at the end of the schedule...
Over the last several years, the pharma industry, along with the world at large, has become increasingly focused on issues of diversity. This has been reflected in regulatory guidelines, government and industry policies and in the clinical trial recruitment phase of...
