AUA
  • Program
  • Register
  • Meeting Coverage
  • Guidelines
  • Industry Highlights
  • Science & Technology Hall
Topics
  • Meeting Coverage
  • Guidelines
  • Industry Highlights
  • Science & Technology Hall
Resources
  • Program
  • Register
Twitter iconFacebook iconInstagram iconYouTube iconLinkedIn icon
Apr 28, 2023

Reaching success in urologic oncology clinical trials

All viable clinical trials start with a strong hypothesis.


Daniel Wei Lin, MD, and Juan Javier-DesLoges, MD
Daniel Wei Lin, MD, and Juan Javier-DesLoges, MD

Clinical trials provide evidence for determining and improving on the standards of care across urologic oncology. The Urologic Oncology Research Symposium explored the ingredients and strategies that help build a successful clinical trial.

Much depends on the type of trial.

“With an investigator-initiated trial (IIT), it is your idea and you have the broadest control,” said Viraj A. Master, MD, PhD, professor, chair of clinical urological research and director of integrative oncology and survivorship at Winship Cancer Institute of Emory University.

IITs tend to be smaller, proof-of-concept studies with smaller budgets.

Industry-sponsored trials give the principal investigator less flexibility than an ITT but larger budgets.

Federally funded trials can be more flexible than industry trials but may carry other restrictions.

National Cancer Institute Trials Network trials give principal investigators little flexibility but offer access to larger resources and populations than industry-sponsored trials.

“No matter the type of trial, all viable clinical trials start with a strong hypothesis,” said Ana Aparichio, MD, professor of genitourinary medical oncology at the University of Texas MD Anderson Cancer Center.

Start with a clear and specific question that addresses a clinically relevant gap in knowledge. Next, define the independent and dependent variables that can affect the answer to the question. Formulate a clear and precise hypothesis, a declarative statement that if this is done, then that specific change will be seen.

The strongest trials incorporate PICO methodology: population, intervention, comparison, and outcome. PICO creates a clear, focused, answerable research question using a transparent and reproducible process.

“The ideal trial is a comparison of a new therapy to the accepted standard of care,” said Stephen A. Boorjian, MD, Carl Rosen Professor and chair of urology at Mayo Clinic. “PICO is the equivalent of the methods section of the trial report.”

Populations matter, too. Lack of diversity in trial data means lack of valid data for Asian, Black, Hispanic, Native American and other patient populations that were not included in trials.

“Every trial has a gatekeeper,” said Juan Javier-DesLoges, MD, MS, assistant professor of urology at the University of California, San Diego. “You have to get in the door of a hospital or cancer center that offers the trial to even be offered the opportunity to participate. The patient and their caregiver are left on their own to figure the system out, if they can even get in the door.”

University of California, San Diego, has focused on hiring a more diverse staff, including language- and culture-specific navigators, language and cultural training for providers and staff, and other steps to increase access to clinical trial information and participation. Hispanic participation in clinical trials has jumped to 21%.

“We need to bring precision medicine principles to clinical trials,” Dr. Javier-DesLoges said. “The right approach to the right patient at the right time, to bring more diversity to our trials.”

Interesting Stories
Check out the AUA’s brand new Gold Open Access journal, <i>JU Open Plus</i>
Sponsored by AUA
Check out the AUA’s brand new Gold Open Access journal, JU Open Plus
Pacific Edge Announces Key Activities at AUA2023
Sponsored by Pacific Edge Diagnostics
Pacific Edge Announces Key Activities at AUA2023
Don’t miss a thing with AUANews
Sponsored by AUA
Don’t miss a thing with AUANews
Reshaping BPH Treatment with the iTind™ Procedure
Sponsored by Olympus
Reshaping BPH Treatment with the iTind™ Procedure
More Content
Getty Images 910070326
Meeting Coverage
Saddle up for AUA2024 in San Antonio
May 11, 2023
Getty Images 1400488393
Meeting Coverage
Healthy debates
May 11, 2023
Getty Images 1345835999
Meeting Coverage
Claim your CME
May 11, 2023
Screen Shot 2023 05 10 At 12 15 03 Pm
Meeting Coverage
Must-see TV
May 11, 2023
Screen Shot 2023 05 02 At 4 48 03 Pm
Meeting Coverage
Read all about it
May 11, 2023
Guide And Rec
Meeting Coverage
Medical guidelines and recommendations take center stage at AUA2023
May 05, 2023
Yeonsoo Sara Lee, BS, medical student
Meeting Coverage
AUA2023 through the eyes of an MD candidate
May 05, 2023
Screen Shot 2023 05 03 At 1 16 42 Pm
Meeting Coverage
AUA2023 On Demand
May 05, 2023
Peter R. Carroll, MD, MPH
Meeting Coverage
Accolades in urology
May 05, 2023
Screen Shot 2023 05 02 At 4 48 33 Pm
Meeting Coverage
Mark your calendars for AUA2024
May 05, 2023
Screen Shot 2023 05 02 At 4 48 03 Pm
Meeting Coverage
Read all about it
May 05, 2023
Isla P. Garraway, MD, PhD
Meeting Coverage
Genetic testing key to targeting prostate cancer
Apr 30, 2023
AUA
Twitter iconFacebook iconInstagram iconYouTube iconLinkedIn icon
© 2023 Ascend Media. All rights reserved.