Sites that take steps to minimize the impact of the placebo effect on trial data not only improve the overall quality of their data, they make themselves more attractive to potential sponsors. Pretrial training of both site staff and trial participants allows sites to control placebo bias from the beginning, saving sponsors time, money and the risk of skewed data. Read More

Quality metrics and their role as part of an overall quality management system (QMS) are an important component of clinical research, but not all sites use quality performance tracking tools to their maximum advantage: tracking quality performance and identifying areas for improvement. Academic and institutional researchers haven’t fully embraced the concept of taking methodical steps to examine operations across individual studies. Read More

One of the key skills of a clinical trial leader is the ability to develop — and stick to — a budget. That means taking into account the cost of executing study protocols, understanding personnel requirements and other trial costs, and identifying potential cost increases and opportunities for cost reduction. Read More

Quality metrics and their role as part of an overall quality management system (QMS) increasingly are drawing attention from clinical research sites, but not all sites may be making maximum use of these tools for tracking quality performance and identifying areas that may be lacking. Read More

Clinical trials increasingly are using genetic testing as a tool to identify trial participants, but the addition of that tool comes with some extra tasks and considerations sites and sponsors must prepare for, including a separate and more detailed informed consent process and patient counseling. Read More

Over the past decade, genetic screening has gained importance in clinical trials in areas other than cancer, including neurology, ophthalmic disease and pain. Read More

Solid, well-thought-out procedures and processes help ensure that all staff at academic medical institutions and other research organizations apply and document consistent standards and practices when conducting studies. Regulatory changes, special researcher- and patient-safety issues, such as those that have arisen since the start of the COVID-19 pandemic, and the industry’s steady move toward adopting wholly or partially decentralized approaches to clinical trials are all factors that can call for updated standard operating procedures (SOPs) to ensure that routine practices accommodate the shifting research environment while maintaining regulatory compliance and data quality and integrity. Read More

The perfect storm of technology advancement, increasing clinical trial complexity and growing FDA acceptance is boosting the use of simulations — including full-blown synthetic control arms for clinical trials — by pharma companies and clinical researchers. Read More

Increased regulator buy-in on the adoption of real-world data (RWD) in trials is leading to more skilled and sophisticated uses of it in trials, finally turning the hoopla around the approach into real-time reality. The potential benefits are significant. Read More

Assessment and proper reporting of adverse events (AEs) and suspected adverse drug reactions (ADRs) form the basis of risk/benefit analysis applied to investigational products. Tracking and assessing different types of AEs and determining which are related to the investigational drug under study are considered some of the most critical roles at research sites. Read More