Year-end Sale % OFF 
Abstract
Assessment of the clinical benefit of cancer treatments can be highly subjective, influenced by both perspective and context. Such assessments are required in regulatory and policy decision-making, but consistency between jurisdictions is often lacking. Clear and consistent standards for determining when a treatment offers a meaningful benefit, relative to the current standard of care, can help to address issues of equity and transparency in health technology assessment. For metastatic colorectal cancer (mcrc), no standardized Canadian definition of clinically meaningful benefit has yet been proposed. Colorectal Cancer Canada therefore convened a group of medical oncologists expert in colorectal cancer to review the literature about clinical significance. The resulting consensus is intended to apply to any therapeutic agent being considered in the setting of chemotherapy-refractory mcrc. It was agreed that overall survival is the appropriate measure of clinical efficacy in chemorefractory mcrc. As quantitative targets for efficacy, an improvement of 2 months or more in median overall survival or a hazard ratio for survival of 0.75 or lower (or both) are proposed as the threshold for clinically meaningful benefit. That threshold could be influenced by a treatment's effect on quality of life. Treatment toxicity is also relevant to the assessment of clinical benefit in this setting, specifically when significant differences in treatment tolerability are evident.
Highlights
Clinical significance refers to the practical or applied value ... of an intervention—whether [it] makes a real difference in everyday life. — A.E
Clinical significance differs from statistical significance in that no standard operational definition exists for determining when clinical significance has been achieved
Two landmark resources were considered, one published by the American Society of Clinical Oncology[7] and one by the European Society for Medical Oncology[8]. The latter organization developed the Magnitude of Clinical Benefit Scale, a validated tool for rating the benefit of a cancer treatment based on data from randomized controlled trials[8]
Summary
Clinical significance refers to the practical or applied value ... of an intervention—whether [it] makes a real (e.g., genuine, palpable, practical, noticeable) difference in everyday life. — A.E. Whether the clinical effect of a treatment differs trivially or substantially from that of the current standard of care is often a matter of judgment, influenced both by the context of the decision and by the perspective of the viewer. Therapeutic benefit of a cancer treatment—namely, patients with cancer, together with their caregivers and the patient organizations that represent them; regulators, including payers and health technology assessment (hta) groups; and treating clinicians, medical oncologists. Of those three groups, patients and regulators almost never interact, but physicians interact frequently and directly with patients, and occasionally and often indirectly with regulators. The treating clinician serves as a bridge between the organizations and individuals who determine policy about treatment access and the patients whose lives are affected by such decisions
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
