When serious things go wrong with a trial, such as an adverse event or an incident report is filed, it is easier for project managers to identify a problem that needs to be addressed in a trial.
When serious things go wrong with a trial, such as an adverse event or an incident report is filed, it is easier for project managers to identify a problem that needs to be addressed in a trial. However, it is the unanticipated and less obvious situations that happen throughout the trial that can put it at risk.
Mark Hronec, Director of PriceWaterhouseCoopers, noted during a December 2013 webinar sponsored by SAS and Applied Clinical Trials titled Myths, Models and Momentum: Risk-Based Monitoring this exact situation. He termed them traditional and non-traditional risk factors. Along the traditional were those previously mentioned—recruitment rates, protocol deviations, serious adverse events, the drug safety profile or the site location or experience at the site. However, those non-traditional risks that could be identified and leveraged using real-time “big data” predictors included average patient visit window deviation, the number of visits the site has per day, the number of inclusion or exclusion criteria, the length of the informed consent form, among others.
Many questions in the webinar were centered on risk-determinations. Laurie Rose, Principal Industry Consultant, Health & Life Sciences at SAS, recommended using historical data, information on past site performance or country and regional numbers; sites that perform better with recruitment, enrollment, and actual study startup. “[With those data, you are] using a predictive model rather than just summarizing and putting then all together. Using a predictive model can help determine basically a better set of expectations of what might come in the future.” Rose also noted other predictive data would include working within the same therapeutic area or other similar compounds from past studies and going to future studies where data is available, but the clinical data and that operational data will be helpful in looking at the next study coming up.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.