U.S./U.K. Team Assesses Impact of Personal Behavior Changes
Double-blind randomized controlled trials of new drugs may fail to measure how a medication’s performance can vary based on patients' lifestyle choices, especially if patients change their habits because they are anticipating treatment, according to a new study published in Plos One.
Double-blind randomized controlled trials of new drugs may fail to measure how a medication’s
performance can vary based on patients' lifestyle choices, especially if patients change their habits because they are anticipating treatment, according to a new study published in Plos One.
"Our proposed design has the potential to better evaluate the effectiveness of treatments targeting conditions related to mental health, substance abuse and smoking cessation, in which behavior is known to play an important role," noted co-lead author Sylvain Chassang, a professor of economics and public affairs at Princeton's Woodrow Wilson School of Public and International Affairs (Princeton, NJ).
Chassang and his collaborators Erik Snowberg from the California Institute of Technology (Pasadena, CA), Ben Seymour from Cambridge University (Cambridge, U.K.) and Caley Bowles from Harvard University School of Public Health (Boston, MA) studied whether the likelihood of receiving a new treatment changes the overall effectiveness of a drug.
They propose a new clinical trial design that varies the probability of treatment across participant groups. Instead of having a 50/50 chance of receiving treatment, participants are placed in high- and low-probability treatment groups. In the high-probability group, there is a 70% chance of receiving treatment while the low-probability group would have only a 30% chance of receiving treatment. Following current guidelines, all participants are made aware of their likelihood of receiving the new treatment.
"It's a very small change to the design of the trial, but it's important," Snowberg said. "The effect of a treatment has these two constituent parts: pure treatment effect and the treatment-behavior
interaction. Standard blind trials just randomize the likelihood of treatment, but if you want to separate out the pure treatment effects and the treatment-behavior interaction effect, then you have to randomize both the treatment and the behavior."
To test their hypothesis that treatment and behavior interact, the researchers conducted a meta-analysis of data from six clinical trials involving two antidepressants, paroxetine and tricyclic imipramine. By changing the variation in the likelihood of treatment across trials, they were able to determine how much of the overall effect is attributable to behavior change alone, the treatment alone and the interaction between the treatment and behavior.
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.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
