Podcast
Monty Pal
Defining a Clinically Meaningful Benefit in Cancer Clinical Trials: From the Perspectives of the Clinical Trialist, Patient, and Society
Summary
In value-based medicine, clinical trials must show both statistically significant and clinically meaningful improvements, such as ASCO's recommendation of a 20% relative improvement in overall survival for metastatic solid tumors. Lawrence et al. found that while many phase III trials met statistical significance, fewer achieved clinically meaningful results, emphasizing the need for ethical trial design and maintaining participant engagement. Quality of life improvements are also crucial, as small survival benefits or reduced toxicity can be significant for patients. Lastly, assessing the value of new therapies involves balancing clinical benefits with costs, which varies by societal and regulatory perspectives.
In an era of value-based medicine, it is increasingly important to design clinical trials of new therapies that not only show statistically significant benefits compared with current standard therapies but also yield an adequate magnitude of benefit to be deemed “clinically meaningful.” In a 2014 recommendation, the American Society of Clinical Oncology (ASCO) indicated that clinical trials studying targeted therapies for metastatic solid tumors need to demonstrate a 20% or more relative improvement in overall survival (OS) (ie, hazard ratio [HR] ≤0.8) to be considered to have a clinically meaningful benefit...
cancer clinical trials, benefit of clinical trials, clinically meaningful, ASCO
Related Topics
You May Also Like
Monty Pal
Article
Di Maria Jiang, Kelvin K. W. Chan, Raymond W. Jang, Christopher Booth, Geoffrey Liu, Eitan Amir, Robert Mason, Louis Everest, Elena Elimova
Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations
Article
Shun-Long Ou, Jing Luo, Hua Wei, Xiao-Li, Qian Jiang
Value assessment of PD-1/PD-L1 inhibitors in the treatment of esophageal and gastrointestinal cancers
Article
Jayson L. Parker, Sebnem S. Kuzulugil, Kirill Pereverzev, Stephen Mac, Gilberto Lopes, Zain Shah, Ashini Weerasinghe, Daniel Rubinger, Adam Falconi, Ayse Bener, Bora Caglayan, Rohan Tangri, Nicholas Mitsakakis
Does biomarker use in oncology improve clinical trial failure risk? A large-scale analysis
Article
Avi Cherla, MSc; Huseyin Naci, MHS, PhD; Aaron S. Kesselheim, MD, JD, MPH; Bishal Gyawali, MD, PhD; Elias Mossialos, MD, PhD
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
Article
Vanessa Arciero, BS, Seanthel Delos Santos, Liza Koshy