Results for 'hematologic'
Browse oncology articles matching hematologic — 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.
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
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
Bridget Rasmusson
Positioning Yourself to Become an MSL in 2022
MSL role, clinical background, academic background, research background, industry, MSL Society, conference, scientific expert, therapeutic expertise, pharma companies
After attending the MSL Society’s 9th annual conference in Vegas Last week, I have taken some time to reflect on inquiries our team received about how to effectively step into the MSL role from a clinical, academic, or research background. Industry is a tough nut to crack, but it is absolutely…
Dec 21st • 10 mins read
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
FDA, NHS, accelerated approval, NICE, clinical trial findings
The study evaluates the acceptance and coverage of FDA-accelerated approved cancer drugs by the National Health Service (NHS) in England, focusing on decisions made by the National Institute for Health and Care Excellence (NICE). A total of 93 cancer drug indications received accelerated approval…
Feb 22nd • 10 mins read
Sean X Zhang, MSc , Dean Fergusson, PhD , Jonathan Kimmelman, PhD
Proportion of Patients in Phase I Oncology Trials Receiving Treatments That Are Ultimately Approved
cancer, biological markers, phase 1 clinical trials, drug approval, medical oncology, united states food and drug administration guidelines, adverse event, national comprehensive cancer network, American society of clinical oncology
Phase I oncology trials are often considered a therapeutic option, but this claim is primarily based on surrogate measures like objective response rates. A systematic search was conducted to evaluate the therapeutic value of phase I cancer trial participation, focusing on the likelihood of patien…
Apr 1st • 14 mins read
E Dawn Flick, Howard R Terebelo, Susan Fish, Amani Kitali, Vrinda Mahajan, Melissa Nifenecker, Kristen Sullivan, Paul Thaler, Sarah Ussery, David L Grinblatt
The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research
registry, oncology, observational study, prospective cohort study, real-world evidence
Oncology patient registries are valuable for generating Real-World Evidence (RWE) due to: Prospective, primary data collection Characterizing smaller patient populations not typically included in clinical trials Providing insights into the rapidly changing disease course Allowing for longitudi…
Jun 7th • 8 mins read
Shen Lin, Yaping Huang, Liangliang Dong, Meiyue Li, Yahong Wang, Dian Gu, Wei Wu, Dongni Nian, Shaohong Luo, Xiaoting Huang, Xiongwei Xu and Xiuhua Weng
The correlation between the costs and clinical benefits of PD-1/PD-L1 inhibitors in malignant tumors: An evaluation based on ASCO and ESMO frameworks
PD-1/PD-L1 inhibitors, malignant tumors, ASCO, ESMO, Immune Checkpoint Inhibitors, Gastrointestinal Cancers
Cancer drug innovation has significantly accelerated in the 21st century, with novel drug approvals and expenditures increasing notably. Assessment frameworks ASCO-VF and ESMO-MCBS were used to evaluate the clinical benefit of PD-1/PD-L1 inhibitors, finding that nearly half of the trials met "mea…
Feb 23rd • 9 mins read
Timothy Qi, Tyler Dunlap, Yanguang Cao1
Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
oncology, precision medicine, tumor evolution, dosing, FDA
Focus on tumor evolution, which leads to therapeutic failure and disease relapse. Emphasis on the effect of tumor evolution on the exposure-response (E-R) relationships of oncology drugs. Advocacy for prioritizing tumor evolution during clinical development to select optimal doses for targeted t…
Sep 2nd • 10 mins read
Jiaxi Zhou, Jonathon Vallejo, Paul Kluetz, Richard Pazdur, Tamy Kim, Patricia Keegan, Ann Farrell, Julia A Beaver, Rajeshwari Sridhara
Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016
drug approval, medical oncology, united states food and drug administration, hematology, surrogate endpoints, marketing, accelerated approval
Background: An overview was conducted of oncology products reviewed by the Office of Oncology Drug Products (OODP) at the FDA for marketing approval between July 2005 and December 2007. The study aims to understand the impact of post-2007 changes in laws, regulations, and organizational structure …
Aug 4th • 15 mins read
Hagop M. Kantarjian MD, Ferran Prat PhD, JD, David P. Steensma MD, Razelle Kurzrock MD, David J. Stewart MD, Mikkael A. Sekeres MD, Joseph Leveque MD
Cancer research in the United States: A critical review of current status and proposal for alternative models
cancer research, research, NCI, Drug industry-driven research model, development in research, 2018 cancer model
Early research focused on tissue histology and animal models, with surgery and radiotherapy as primary treatments. 1950s: Introduction of cell lines (e.g., HeLa cells) and first anticancer drugs (antifolates, thiopurines), leading to the establishment of the Cancer Chemotherapy National Service C…
May 14th • 10 mins read