Senior Project Director
Senior Project Director
A pain expert at Rho, Ms. Baggett has over 14 years of clinical trial experience. In the last 8 years alone, she has led 3 chronic pain studies and 7 acute pain studies across 5 programs. This success is partly due to her keen understanding of the unique challenges inherent to chronic and acute pain studies such as accurate pain reporting for efficacy endpoints, operational challenges resulting from swift enrollment on elective surgical models for acute pain, and subject retention challenges for single-injection chronic pain studies.
In 2017, Ms. Baggett earned her Regulatory Affairs Certification (RAC) which provides her with a deeper understanding of regulatory requirements and challenges facing her clients. That, paired with her strong understanding of clinical trial management and innate ability to create strong site-sponsor relationships almost instantly, Ms. Baggett regularly leads teams to meet or beat timeline deliverables for various multicenter trials. On a large Phase 3 OA knee pain trial for example, she worked very closely with study sites and together, completed enrollment six weeks early.
Ms. Baggett also has 6 years of experience as a data manager. This added perspective fosters a more clear understanding of the link between clinical and biometric activities and allows her to provide her clients with high-quality data.
Regularly working with many of the industry-standard pain scales and quality-of-life questionnaires (in both paper and ePRO form), Ms. Baggett frequently helps her clients navigate the balance of quality data collection, patient burden, and cost with regards to these collection mediums.
Ms. Baggett earned her bachelor of science degree in Exercise Science at East Carolina University.
“Pain medications have come into the spotlight recently due to the national opioid crisis, but the problem is one I’ve long been interested in. While opioids are very effective pain medications, there are many risks to the patients who use them. We must be better in striking the balance between risk and benefit for patients. We must be better in understanding these medications and their effects over time. And we simply cannot do that without good science and education. And I want to do my part, however small, to effectively treat pain while helping to bring safer pain treatments to market.”
This is what drives Becky:
“I love a good challenge! Every study that I work on, although they have similar properties, each is their own unique snowflake. Each client, each protocol, presents a new challenge that I cannot wait to figure out. I’m absolutely relentless in my need to fully understand the goals and the history of each program that I work on, and that my team understands them as well.”
Content by Becky Baggett
Completing enrollment is typically one of the most critical milestones in a clinical trial. Enrollment delays impact the study budget, site resources, and downstream timelines. Therefore, it is important to identify potential risks to enrollment early in the study, even during the protocol development process if possible. Defining risk mitigation strategies and setting quality tolerance limits allows the study team to quickly identify when a strategy must be implemented to keep enrollment on track. In this webinar, we will discuss how we have used a risk-based quality management system to document enrollment risks and creative solutions we have implemented.
There are a lot of resources on how to deal with slow enrolling studies, but what about challenges with studies that enroll very quickly? Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution.