Results for '5 e's framework'
Browse oncology articles matching 5 e's framework — expert analysis, clinical perspectives, and industry updates from across drug development and care delivery. Use the tabs above for podcasts, press releases, partners, and people for the same search.
David J. Segarnick, PhD Chief Medical Officer, Educational Resource Systems Adjunct Associate Professor, Rutgers New Jersey Medical School Department of Pharmacology, Physiology & Neuroscience David E. Wazer, MD, FACRO, FABS, FACR, FASTRO Research Scholar
From Genomic Testing to Digital Biomarkers: The Expanding Role of Biomarkers in Oncology
oncology biomarkers, precision oncology, predictive biomarkers
Biomarkers have moved from the margins of oncology to the center of clinical decision-making. They now help establish diagnosis and prognosis, identify patients most likely to benefit from targeted therapy or immunotherapy, monitor response, detect molecular residual disease and emerging resistance,…
Aug 20th • 35 mins read
Jürgen Wiehn, Marian Duven
Why leadership teams become dependent on pressure and what it costs performance
leadership, career, performance
In many high-performing environments, pressure is not the exception. It becomes the operating baseline. Deadlines compress.Decisions stack.Communication tightens.Expectations increase. And over time, something subtle but important happens. Leadership teams begin to rely on pressure to function. …
Apr 13th • 5 mins read
Michael Pietrack
Leadership Lab: How To Spot When Employees Are About To Walk Away
Employees rarely leave companies for one reason alone. In this column, Kaye/Bassman’s Michael Pietrack shares a framework that helps leaders identify when their team members are thinking about heading for the exit—and how to address it.
Oct 22nd • 7 mins read
Michael Pietrack
How to Know When to Make a Job Change
In career conversations, one of the most common questions I hear is: “How do I know if it’s time to move on from my company?” The real decision often comes down to a mix of factors that influence job satisfaction and long-term career growth. That’s why I use the CLAMPS framework. CLAMPS …
Aug 26th • 5 mins read
Shani Paluch-Shimon, Nathan I. Cherny, Elisabeth G.E. de Vries, Urania Dafni, Martine J. Piccart, Nicola Jane Latino, Fatima Cardoso
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies
early breast cancer, magnitude of clinical benefit scale, ESMO-MCBS
The ESMO-MCBS is a validated value scale for assessing solid tumour anticancer treatments, specifically for therapies with curative intent. This document represents the first large-scale field testing of the ESMO-MCBS in early breast cancer to assess its applicability and identify any sh…
Sep 6th • 20 mins read
Eric Q. Konnick
The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation
Oncology, Regulation, Testing, LDTs, FDA, CLIA, CMS
The regulatory landscape for precision oncology in the United States is complex, involving multiple governmental agencies with varying jurisdictions. Since 2014, several regulatory proposals have been introduced following the FDA's draft guidance on laboratory-developed tests. There are ongoing …
May 22nd • 8 mins read
Nicole Grossmann, Martin Robausch, Eleen Rothschedl, Claudia Wild, Judit Simon
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
Antineoplastic agents, Health-related quality of life, Clinical efficacy, Drug approvals, Patient-relevant outcomes
The study investigates cancer drugs approved by the European Medicines Agency (EMA) that initially lack Health-related Quality of Life (HRQoL) information. Data was collected for cancer indications approved between January 2009 and October 2015, using sources like the EMA website, clinical…
Feb 23rd • 12 mins read
Barbara Kiesewetter , Nathan I Cherny, Nicolas Boissel, Francesco Cerisoli, Urania Dafni, Elisabeth G E de Vries, Paolo Ghia, Nicola Gökbuget, Verónica González-Calle, Brian Huntly, Ulrich Jäger, Nicola Jane Latino, Jean-Yves Douillard, Luca Malcovati, Ma
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
ESMO, hematological malignancies, Clinical benefit scale, EHA
The ESMO-MCBS v1.1 has not been previously validated for haematological malignancies, but it is being explored to avoid duplication of efforts. A feasibility test was conducted using 80 studies related to various haematological malignancies such as acute and chronic leukaemia, lymphoma, myel…
Jan 20th • 20 mins read
K. Ribi, N. Kalbermatten, M. Eicher, F. Strasser
Towards a novel approach guiding the decision-making process for anticancer treatment in patients with advanced cancer: framework for systemic anticancer treatment with palliative intent
Patient-centered cancer care, Advanced cancer decision-making, Stepwise decisional process, Palliative care domains, Illness understanding in oncology, Symptom control in cancer, End-of-life preparation, Patient-physician interaction, SACT-PI Decision Fra
Patient-centered decisions in advanced cancer care demand a step-wise decisional process, not a single decision act. The decision process includes key palliative care domains, e.g. illness understanding, symptom control, or end-of-life preparation. Patients' attitudes, beliefs, hopes, patient-ph…
Jun 1st • 25 mins read
Envision Pharma Group
Medical affairs: The power behind redefining commercialization
Medical affairs commercialization, integrating science in pharma, redefining medical affairs roles, strategic medical affairs leadership, early engagement with payers, pharmaceutical commercialization strategies, upskilling in medical affairs, medical aff
In March 2024, Envision Pharma Group held a Medical Affairs Professional Society (MAPS) Americas roundtable with leaders discussing the role of science in commercialization strategies and the importance of integrating robust scientific understanding into the commercial journey. Envision revisite…
Aug 2nd • 3 mins read
Rajat Thawani, Neha Agrawal, Nicholas F Taflin, Adel Kardosh, Emerson Y Chen
Application of Value Framework to Phase III Trials of Immune Checkpoint Inhibitors in Esophageal and Gastric Cancer
esophageal cancer, gastric cancer, comparative effectiveness research, outcome assessment, antineoplastic agents, immunotherapy
Immunotherapy checkpoint inhibitors are FDA-approved for first-line metastatic esophageal and gastric cancer, but not all scenarios benefit from non-selective chemo-immunotherapy application. ASCO Net Health scores were consistently higher in esophageal cancer trials compared to gastric cancer tr…
Jan 13th • 8 mins read
Francesco Cerisoli, PhD, Farzad Ali, MSc, Tamás Bereczky, MA, PhD, Natacha Bolaños, BS, Lars Bullinger, MD, Sujith Dhanasiri, MPhil, MSc, James Gallagher, PhD, Sonia García Pérez, MSc, Jan Geissler, MiBA, Yann Guillevic, DEA, Kathryn Harrison, PhD, Anasta
Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in Hematology Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools
clinical value framework, hematology, Healthcare Alliance for Resourceful Medicine, Offensive Against Neoplasms in hematology, patient-reported outcomes, HARMONY, analysis
Current Value Frameworks (VFs) have limitations and do not meet HARMONY's ambitions for assessing the therapeutic/clinical value of innovative health technologies. There is a need for a cross-stakeholder agreement on the definition of "value," which varies among patients, clinicians, and payers. …
May 17th • 12 mins read
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
ASCO VF, ESMO MCBS, gastrointestinal malignancies, anticancer drugs
Drugs approved between 2006 and 2017 were analyzed. Clinical benefit was measured using ESMO Magnitude of Clinical Benefit Scale and ASCO Value Framework. 16 GI cancer drugs received FDA approval for 24 indications, including various drug classes such as monoclonal antibodies, oral targeted …
Mar 7th • 8 mins read
M. Bertagnolli and J. Tabernero
Value assessment frameworks in oncology: championing concordance through shared standards
The ASCO Value Framework Net Health Benefit Score (ASCO-NHB) and the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), introduced in 2015, are essential tools for assessing the relative benefit of cancer therapies. Both ASCO and ESMO continually refine these frameworks and engage with stakeholde…
Feb 18th • 1 min read