Conversations in Clinical Trial Readiness - Struggling with the Silent Killer: An Honest Look at How Demanding Oncology Trials Have Become with Rebecca Setta

Struggling with the Silent Killer: An Honest Look at How Demanding Oncology Trials Have Become with Rebecca Setta

04/20/21 • 28 min

Conversations in Clinical Trial Readiness

Rebecca Setta is an Associate Director at OncoSec whose 13 years of experience in clinical trials have given her the benefit of several different perspectives. Rebecca began her career on the vendor side, and her continuous pursuit of development and higher-level understanding led her to transition to the CRO space in 2015. Her role at OncoSec represents the natural evolution of a career shaped around an inherent desire for growth through further immersion in clinical trials.

In Rebecca’s years of experience at the project level, she consistently found building effective teams to be among the most rewarding elements of her work. She now brings that expertise to bear at the department level, where she can act as a mentor, shaping a team to build on her knowledge and experience.

Episode Highlights

How Rebecca helps her team avoid burnout in a grueling field
The common characteristics she saw across the sites that adapted best at the start of the pandemic
The crucial change in mindset that she’s encouraged in her CRAs
The COVID-inflicted adaptations she expects to persist post-pandemic
Why it’s important to partner with sites
The unexpected upside to the pandemic adjustments her sites have made
What really impresses her about the industry
How remote work and limited face time can impact morale, and one way she compensates for that
How the weighty context of oncology research can also translate to motivation
Why she is so excited about the future of the industry

Resources

https://oncosec.com

https://www.linkedin.com/company/oncosec-medical-inc/

https://twitter.com/oncosec

Episode Highlights

How Rebecca helps her team avoid burnout in a grueling field
The common characteristics she saw across the sites that adapted best at the start of the pandemic
The crucial change in mindset that she’s encouraged in her CRAs
The COVID-inflicted adaptations she expects to persist post-pandemic
Why it’s important to partner with sites
The unexpected upside to the pandemic adjustments her sites have made
What really impresses her about the industry
How remote work and limited face time can impact morale, and one way she compensates for that
How the weighty context of oncology research can also translate to motivation
Why she is so excited about the future of the industry

Resources

https://oncosec.com

https://www.linkedin.com/company/oncosec-medical-inc/

https://twitter.com/oncosec

Previous Episode

What Do You Do When You Don't Have Enough Trial Locations? with Krystyna Kowalczyk

Topics covered and questions you’ll uncover during this episode:

The three tenets of OncoBay’s approach to cutting-edge cancer research
How to prepare staff for the complexities of a 21st-century oncology trial
Why we need to evolve from serial to real-time data assessment
OncoBay’s “just-in-time” enrollment model (and a touching success story)
Why investing up-front in site preparedness is critical to maximizing impact in research
How the just-in-time model can help address diversity challenges in enrollment
Why new technologies and methodologies often create discomfort, and what leaders can do about it
How you can make 1 + 1 equal 3 when you combine tools effectively
Why putting together the right team is both more challenging and more critical than putting together the technology
What Krystyna looks for when assessing potential team members
Why she’s excited for the next generation of industry employees

Resources mentioned within the episode:

Next Episode

undefined - How Can We Manage the Increasing Complexity of Clinical Trial Protocols? Interview with Ken Getz of Tufts Center for the Study of Drug Development

How Can We Manage the Increasing Complexity of Clinical Trial Protocols? Interview with Ken Getz of Tufts Center for the Study of Drug Development

Ken Getz is the Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine. Ken is an expert in drug development management and practices who has dedicated much of his career to raising awareness of clinical research enterprise.

In addition to frequently speaking at industry events and publishing in peer-reviewed journals, Ken is the founder of several organizations, including the non-profit CISCRP and the publisher CenterWatch. His career is a true testament to his belief in the importance of transparency and keeping all clinical research stakeholders well-informed.

Episode Highlights

The takeaways, both expected and surprising, from 2020 protocol performance data
The factors that are contributing to increased complexity in clinical trial protocols
Why simplifying the design of a study is not the right goal
The inherent benefits in complexity, and how we can reap them through proper management
What drives regulatory agencies to seek to quell rising complexity in clinical trial protocols
Why more data isn’t necessarily better
The importance of investigating underlying causes of problems rather than defaulting to solving them with volume
What happened to feasibility committees and what should replace them
Why it’s critical to incorporate patient input into study design
The consistent positive impact of patient advisory boards
How taking the time for thoughtful advanced planning can help preclude costly unplanned amendments later on