Those who dig deep into research methodologies know well the inherent biases that riddle much scientific and medical research. (See my postscript reference below) Clinical trials are not exceptions to these biases and, as drug companies look to produce the best outcomes for their clinical trials, patient selection (IMO) stands as #1 in that category. In her interview, Dr. Morgans' highlight that specific bias. It seems near universal in PCa drug development, affecting both dosing protocols and expected outcomes/efficacy.
From the article's lead-in to the interview:
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Most men diagnosed with prostate cancer are older than 65. In clinical trials, however, the participants tend to be younger and more fit than real-world patients, noted authors of a review in the ASCO Educational Book.
"Therefore, despite the incidence of prostate cancer peaking in older age, it is not known whether older men derive the same benefit from the treatment strategies used in younger men," said Alicia Morgans, MD, MPH of Dana-Farber Cancer Institute and Harvard Medical School in Boston, and co-authors.
Given this, geriatric assessments to determine a patient's frailty or fitness and inform treatment decisions are important in prostate cancer patients older than 65. These assessments can help avoid overtreating frailer men or undertreating fitter ones, the authors explained.
In their review, the team covered evidence-based risk-assessment tools for older men with prostate cancer as well as intervention strategies to improve treatment tolerance.
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The full interview (with links to a review and expert commentary) is at the link below:
Alicia Morgans, MD, on Prostate Cancer in Older Men– Determining frailty or fitness will help guide treatment decisions, by Jeff Minerd , Contributing Writer, MedPage Today November 27, 2023
medpagetoday.com/reading-ro...
Stay Safe & Well,
Ciao - Cujoe
PS For those that want to understand the many challenges (frequently leading to flawed results) for scientific research, this Peter Attia interview with Stanford's John Ioannidis is a very good place to start.
The Peter Attia Drive Podcast #143 - John Ioannidis, M.D., D.Sc.: Why most biomedical research is flawed, and how to improve it