The Tufts Center for the Study of Drug Development announced that it has established the first global benchmark for clinical research associate (CRA) workload and utilization, giving managers insights into improving CRA effectiveness and efficiency.
CRAs are based in the field and they are responsible for overseeing and closely monitoring clinical studies conducted by research centers.
"Over the past 15 years, demands on study monitors have intensified as clinical trial volume and complexity has increased. Yet, drug development managers haven't had benchmarked global metrics to assess their CRA field force capacity and utilization," said Ken Getz, Tufts CSDD senior research fellow and assistant professor at Tufts University, who conducted the study.
According to Tufts CSDD, CRAs worldwide spent approximately 20% of their time traveling and devoted 41% of their time at clinical trial sites. Getz noted that prior to the study the research-based drug industry widely believed that CRAs spent 60% of their time on-site.
In addition, the study found that CRA workload and time allocation varies widely by geographic region with U.S.-based study monitors spending more time traveling and on site than their counterparts elsewhere. European study monitors spend relatively more time performing off-site monitoring and administrative tasks.
According to Tufts CSDD, there are 20,000 - 23,000 CRAs supporting clinical research studies worldwide.
"CRAs play an integral role in the drug development process as they are the people who ensure the safety of trial participants, the quality of clinical data, and the compliance by investigative site staff with the study protocol." said Getz. "Knowing how much time CRAs spend on specific tasks gives managers and regulators a way to refine practices and policies aimed at enhancing CRA effectiveness and efficiency."
The Tufts CSDD study, reported in the January/February Tufts CSDD Impact Report, released today, also found that:
* For Phase I studies, CRAs on average conduct 3.8 investigative site visits each month.
* For Phase II-III studies, CRAs on average conduct 7.9 investigative site visits each month.
* CRAs overall have an average of 6.3 years on the job and expect to remain in their position for another 3 years, with both metrics varying widely by region.
Zenocutuzumab Shows Durable Efficacy in NRG1 Fusion-Positive Cancers in Phase II eNRGy Trial
February 13th 2025The Phase II eNRGy trial showed durable antitumor activity with zenocutuzumab (Bizengri) in patients with NRG1 fusion–positive cancers, particularly non-small cell lung cancer and pancreatic cancer.
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.
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.
SCOPE Summit 2025: Enhancing the Patient Experience Through Site Centricity
February 12th 2025In an interview with ACT senior editor Andy Studna at SCOPE Summit, Ashley Davidson, vice president, product lead - sponsor tech strategy, Advarra, highlights the need for more site-centric approaches in study startup.