Conversations in Clinical Trial Readiness - 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

06/02/21 • 39 min

Conversations in Clinical Trial Readiness

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

Resources:

Tufts Center for the Study of Drug Development
Ken Getz on LinkedIn
CISCRP
CenterWatch
Conversations in Clinical Trial Readiness Interview Series

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

Resources:

Tufts Center for the Study of Drug Development
Ken Getz on LinkedIn
CISCRP
CenterWatch
Conversations in Clinical Trial Readiness Interview Series

Previous Episode

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

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

Next Episode

Increasing Access to People of African Descent in Pharma: Interview with Peju Oshisanya

Peju Oshisanya

Peju Oshisanya is a Director and Clinical Program Leader at BenevolentAI. With more than 20 years in the drug research industry, Peju is an expert in pharmaceutical organization. Her career has run the gamut from early roles as a clinical trial associate to extensive experience running a wide range of global clinical research programs. In her role at BenevolentAI, she pairs her biomedical science background with further perspective from the tech side.

Peju is a passionate proponent of diversity in data and inclusion in clinical trial research. She believes that problems of diversity and inclusion are fixable, and she has determined to become a champion of that change, working to raise awareness and dedicating her own career to upend the status quo.

Episode Highlights

Peju’s “aha” moment that drove home the magnitude of inequity in biopharma, health, and clinical trials
Why it’s crucial to really understand the communities that we want to include in research
How decision-makers’ personal perspectives influence which diseases are prioritized and which treatments are funded
Why representation needs to extend to the experts rather than stopping with the patient population
Why it’s misleading and counter-productive to frame populations using the term “minority”
How helping patients understand the importance of research in informing treatments can help motivate participation
The huge potential opportunity Africa represents for clinical trials
The problem of perception when it comes to African institutions’ preparedness
How mining past data can create a self-perpetuating cycle that prevents capable sites from becoming experienced sites
What we can do to help ameliorate diverse patient populations’ trust in the healthcare industry
How anyone, regardless of their role within a company, can take steps to influence diversity in research
How the pandemic has signaled hope for diversity and inclusion going forward