PLYMOUTH MEETING, Pa.,
Dec. 15, 2021 /PRNewswire/ -- New
research in the December 2021 issue
of JNCCN—Journal of the National Comprehensive Cancer
Network found that only 59% of oncology clinical trials
studied provided adequately-defined rules for censoring. The
researchers examined published randomized control trials supporting
FDA approval for treatments for solid tumors from January 2015 through December 2019—and found that
for 33 out of 81 studies, it was not clear in the publication why
or how patients were being censored.
Censoring is defined in this context as the practice of removing
patients from follow-up before experiencing the outcome of
interest; for instance, if the main outcome of a cancer treatment
trial is survival and the patient experiences a heart attack and
withdraws from the trial, they may no longer be followed-up. If the
proportion of patients who are censored is not evenly balanced
between comparison groups, this can introduce bias and makes it
difficult to interpret the results of trials.
"We hope that our findings will prompt investigators and
journals to report early drug discontinuation, withdrawal of
consent, loss to follow-up, and censoring more transparently in
trial publications. This would allow patients and clinicians to
make more informed decisions regarding the potential benefits of a
treatment," said lead researcher Brooke
E. Wilson, MBBS, MSc, University of
Toronto. "Regulatory authorities and journals can play a
leadership role in mandating improved transparency and ensuring
that censoring data be made publicly available."
The authors compiled a list of goals and recommendations to
improve transparency and reporting in clinical trials. Those goals
include:
- Minimize the chance of post-randomization bias
- Improve transparency regarding censoring methods in oncology
trials
- Explore the impact of censoring on trial results
- Improve the handling of transparency of missing outcome data in
trial results
- Acknowledge the potential impact of censoring on the
interpretation of results
- Provide transparent information regarding early drug
discontinuation and withdrawal of consent or loss to follow-up
"In trials with survival outcomes, it's important to clearly and
carefully define censoring," commented Elizabeth A. Handorf, PhD, Associate Research
Professor, Fox Chase Cancer Center, who was not involved in
this research. "It's possible that different ways of defining or
handling censoring could change the results. It's concerning that
so few studies presented sensitivity analyses, as this is the best
way for the reader to understand the potential impact of the
study's definitions and assumptions. I was surprised to see that 54
studies had a planned sensitivity analysis for censoring rules but
only 3 published the results. Even if a sensitivity analysis shows
no difference, those results are useful to include."
To read the entire study, visit JNCCN.org. Complimentary access
to "Quantifying Withdrawal of Consent, Loss to Follow-Up, Early
Drug Discontinuation, and Censoring in Oncology Trials" is
available until March 10, 2022.
About JNCCN—Journal of the National
Comprehensive Cancer Network
More than 25,000 oncologists and other cancer care professionals
across the United States
read JNCCN—Journal of the National Comprehensive Cancer
Network. This peer-reviewed, indexed medical journal provides
the latest information about innovation in translational medicine,
and scientific studies related to oncology health services
research, including quality care and value, bioethics, comparative
and cost effectiveness, public policy, and interventional research
on supportive care and
survivorship. JNCCN features updates on the NCCN
Clinical Practice Guidelines in Oncology (NCCN
Guidelines®), review articles elaborating on guidelines
recommendations, health services research, and case reports
highlighting molecular insights in patient
care. JNCCN is published by Harborside.
Visit JNCCN.org. To inquire if you are eligible for
a FREE subscription to JNCCN,
visit NCCN.org/jnccn/subscribe. Follow JNCCN on Twitter
@JNCCN.
About the National Comprehensive Cancer Network
The
National Comprehensive Cancer Network®
(NCCN®) is a not-for-profit alliance of
leading cancer centers devoted to patient care, research,
and education. NCCN is dedicated to improving and facilitating
quality, effective, equitable, and accessible cancer care so all
patients can live better lives. The NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines®)
provide transparent, evidence-based, expert consensus
recommendations for cancer treatment, prevention, and supportive
services; they are the recognized standard for clinical direction
and policy in cancer management and the most thorough and
frequently-updated clinical practice guidelines available in any
area of medicine. The NCCN Guidelines for
Patients® provide expert cancer treatment
information to inform and empower patients and caregivers, through
support from the NCCN Foundation®. NCCN also
advances continuing education, global initiatives,
policy, and research collaboration and
publication in oncology. Visit NCCN.org for more information
and follow NCCN on Facebook @NCCNorg, Instagram @NCCNorg, and
Twitter @NCCN.
Media Contact:
Rachel
Darwin
267-622-6624
darwin@nccn.org
View original content to download
multimedia:https://www.prnewswire.com/news-releases/new-research-in-jnccn-raises-concerns-about-clinical-trial-bias-from-undisclosed-censoring-301444772.html
SOURCE National Comprehensive Cancer Network