Results for 'decision-making'
Browse oncology articles matching decision-making — 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.
Melissa H. Roberts & Gary T. Ferguson
Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
Real world evidence, RWE, payer decisions, RWD
Randomized controlled trials (RCTs) are preferred by payers for health technology assessments and coverage decisions, but they may not reflect real-world clinical practice. Real-world evidence (RWE) from observational studies can fill evidence gaps not addressed by RCTs and is valuable for payer …
Jun 18th • 6 mins read
Doreen A. Ezeife MD, Francois Dionne PhD, Aline Fusco Fares MD, Ellen Laura Rose Cusano MD, Rouhi Fazelzad BSc, MISt, Wenzie Ng BSc, MPharm, RPh, Don Husereau BSc Pharm, MSc, Farzad Ali BPharm, MSc, Christina Sit MSc, Barry Stein B.Com BCL, LLB, Jennifer
Value assessment of oncology drugs using a weighted criterion-based approach
anticancer therapy, multicriteria decision analysis, value assessment, value assessment framework
The rising cost of anticancer therapy has led to efforts to quantify the overall value of new cancer treatments. Multicriteria decision analysis is used to incorporate multiple criteria and perspectives into value assessment. A diverse, multistakeholder group developed a drug assessment framewor…
Dec 20th • 15 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
Gracy Crane, John C. W. Lim, Churn-Shiouh Gau, Jipan Xie & Laura Chu
The challenges and opportunities in using real-world data to drive advances in healthcare in East Asia: expert panel recommendations
Real-world data, real-world evidenc, East Asia, policy recommendations, decision-making support, East Asia, expert, RWD, RWE
Recommend approaches to improve the use of Real-World Evidence (RWE) in healthcare decision-making in East Asia and beyond. Encourage large-scale collaborations involving diverse stakeholders. Key stakeholders include government agencies, hospitals, research organizations, patient groups, and th…
Jun 28th • 13 mins read
Leon Rozen
Medical Judgment at the Point of Decision
Medical Strategy, Medical Leadership, Medical Affairs
Why Experience Matters in Local Medical and Clinical Leadership
Feb 12th • 5 mins read
Diana Brixner, PhD, RPh Diana.Brixner@utah.edu, Joseph Biskupiak, PhD, MBA, Gary Oderda, PharmD, MPH, Douglas Burgoyne, PharmD, FAMCP, Daniel C Malone, RPh, PhD, FAMCP, Bhakti Arondekar, PhD, MBA, and Alexander Niyazov, PharmD, RPh, MPH
Payer perceptions of the use of real-world evidence in oncology-based decision making
real world evidence, RWE, RCT, randomized controlled trials, payer, perceptions, FDA
US payers find real-world evidence (RWE) useful for improving costs and outcomes in oncology, and for making formulary decisions. Payers prioritize comparative effectiveness evidence but also value other RWE types such as total cost of care, burden of illness, treatment patterns, and economic…
Aug 1st • 12 mins read
Fernando Petracci, Chirag Ghai, Andrew Pangilinan, Luis Alberto Suarez, Roberto Uehara, Marwan Ghosn
Use of real-world evidence for oncology clinical decision making in emerging economies
Asia-Pacific, effectiveness, electronic database, health policy, Latin America, Middle East, randomized clinical trials, real-world data, real-world evidence, safety
Despite RWE being a relatively nascent concept in emerging economies, we have seen evidence of increasing use over the past 5 years growing at 11% per year. That said, barriers specific to emerging economies need to be overcome through collaborative efforts, with regulatory agencies at the forefront…
May 5th • 12 mins read
MAXIMILIAN SALCHER-KONRAD, HUSEYIN NACI, COURTNEY DAVIS
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States
pharmaceutical regulation, US Food and Drug Administration, European Medicines Agency, cancer.
Regulatory agencies often have limited evidence on the clinical benefits and harms of new drugs at the time of market approval. There is frequent discordance between the FDA and EMA in regulatory outcomes and the use of special regulatory pathways for cancer drugs of uncertain therapeutic value. …
Oct 6th • 48 mins read
Leon Rozen
Business Acumen Is Not Strategic Judgment
Medical Strategy, Medical Leadership, Medical Affairs
Why Senior Medical Support Requires More Than Understanding the Business
Feb 11th • 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
Practical Advice for When You're Downsized. What Activities will Pay-off after a Lay-off?
Have you or someone you know recently been downsized, laid off, or RIF’d? If so, you’re going to want to watch and share this video. When one is downsized, there is a range of emotions. Some feel betrayed and carry hurt feelings, while others fight with the fear of uncertainty and the reality…
Sep 15th • 5 mins read
Michael Pietrack
The Four Employment Agreement Questions Every Pharma Executive Must Ask
opinion, career advice, leaderhsip, legal
Clarity on employment terms is essential to protect careers. In this column, Kaye/Bassman’s Michael Pietrack speaks to employment attorney Howard Matalon, JD, partner at OlenderFeldman, on how to evaluate the fine print of an employment agreement.
Dec 18th • 6 mins read
iNIZIO
Virtual Oncology MSL Team Increases KOL Engagement by 120%
Case Study (US) The Challenge Client needed comprehensive, scalable and innovative model. Goal: Cost-effectively supplement field based MSL team to provide national coverage. Objective: Share newly published guidelines with KOLs and gain key strategic insights. The Approach Highly …
Sep 3rd • 1 min read
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 mins read
B. Gyawali, E. G. E. de Vries, U. Dafni, T. Amaral, J. Barriuso, J. Bogaerts, A. Calles, G. Curigliano, C. Gomez-Roca, B. Kiesewetter, S. Oosting, A. Passaro, G. Pentheroudakis, M. Piccart, F. Roitberg, J. Tabernero, N. Tarazona, D. Trapani, R. Wester, G.
Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring
ESMO-MCBS, bias, clinical trial design, clinical trial implementation, clinical trial reporting, clinical trial analysis
The ESMO-MCBS is a tool used for scoring the clinical benefit of cancer medicines as reported in clinical trials, assuming valid research methodologies and quality implementation. The tool's effectiveness is compromised by studies with flawed design, implementation, or data analysis, w…
Apr 20th • 8 mins read
Vanessa Arciero, BS, Seanthel Delos Santos, Liza Koshy
Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review
ESMO, MCBS, FDA, ASCO-VF, EMA, QOL
Recent oncology therapies approved by the FDA and EMA often lack evidence of clinically meaningful improvements in quality of life (QOL). Only 40% of FDA-approved and 58% of EMA-approved oncology therapies had published QOL evidence. Clinically meaningful QOL improvements beyond minimal dif…
Feb 11th • 4 mins read
Fei Liang, Sheng Zhang, Qin Wang, Wenfeng Li
Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
Randomized trials, Clinical benefits, Immune checkpoint inhibitors, Cancer, Food and drug administration agency
The study evaluates the clinical benefits of immune checkpoint inhibitors using the ESMO-MCBS and ASCO VF scales. 18 indications for these inhibitors were approved based on RCTs conducted between 2011 and 2018. All indications meet the ESMO-MCBS 1.1 threshold for meaningful bene…
Aug 31st • 16 mins read
Ashley Woolmore , Dirk Arnold , Jean‐Yves Blay , Christian Buske , Alfredo Carrato , Winald Gerritsen , Marc Peeters , Jesus Garcia‐Foncillas , David Kerr
The Oncology Data Network (ODN): Methodology, Challenges, and Achievements
The oncology data network, ODN
The Oncology Data Network (ODN) aims to create a collaborative infrastructure for precision medicine, established in over seven European countries with 124 cancer centers. The ODN collects concise data on cancer medicine use, adhering to EU GDPR regulations, and has a central European Data Wareho…
May 21st • 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