Results for 'Treatment Evaluation'
S.F. Oosting, J. Barriuso, A. Bottomley, M. Galotti, B. Gyawali, B. Kiesewetter, N.J. Latino, F. Martinelli, M. Pe, G. Pentheroudakis, F. Roitberg, H. Vachon, E.G.E. de Vries, M. Piccart, N.I. Cherny
Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale
Benefit Scale, MCBS, Quality of Life, Health Assessment, Oncology Scale, Cancer Guidelines, Treatment Evaluation, Medicine Scoring
The ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) was introduced in 2015 to standardize the assessment of clinical benefits from cancer treatments. ESMO-MCBS helps in health-technology assessment, especially given the increasing number of treatment options and rising cancer care costs. Ne…
Apr 1st • 30 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
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
Tom Caravela
MSL Evolution: New Trends and Titles That May Emerge
digital marketing strategies, SEO best practices, content marketing tips, social media optimization, keyword research tools
The COVID-19 pandemic has clearly had a profound impact on Field Medical Affairs. Has the Medical Science Liaison role changed forever? What new titles, trends and opportunities might emerge as a result of the new age for Field Medical and the evolution of the Medical Science Liaison? Is virtual en…
Apr 5th • 1 min read
Xuanyi Li, Elizabeth A. Sigworth, Adrianne H. Wu, Jess Behrens, Shervin A. Etemad, Seema Nagpal, Ronald S. Go, Kristin Wuichet, Eddy J. Chen, Samuel M. Rubinstein, Neeta K. Venepalli, Benjamin F. Tillman, Andrew J. Cowan, Martin W. Schoen, Andrew Malty, J
Seven decades of chemotherapy clinical trials: a pan-cancer social network analysis
Cancer Medical research, Randomized controlled trials, Clinical trial design
Clinical trials are crucial in establishing cancer care standards, but the social dynamics among researchers in this field have not been extensively studied. A social network analysis of authors involved in chemotherapy-based prospective trials from 1946 to 2018 reveals significant insights. The …
Oct 16th • 12 mins read
Muneera Al Hussain
Comment on: Oncology research in Saudi Arabia over a 10-year period. A synopsis
oncology research, saudi arabia
An article in the Saudi Medical Journal by Alghamdi et al reported on oncology research progress in Saudi Arabia. The study compared research quantity and quality between two periods: 2008-2012 and 2013-2017. There was an increase in the amount of research over time, but quality and scienti…
Jun 24th • 3 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
Jingjing Yu, Isabelle Ragueneau-Majlessi
In Vitro-to-In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
In Vitro-to-In Vivo, Transporter Inhibition Data, Drug Approval, FDA, 2018
The analysis focuses on inhibition transporter data from New Drug Applications approved by the FDA in 2018, involving 42 drugs. Key points include: In vitro-to-in vivo predictions were available for nine recommended transporters. 29 parent drugs and 16 metabolites inhibited at least one transpor…
Jan 25th • 12 mins read
Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies
biologics, external validity, FDA, biosimilars, trastuzumab
Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…
Apr 6th • 2 mins read
Mahnum Shahzad, BA, Huseyin Naci, MHS, PhD, Anita K. Wagner, PharmD, MPH, DrPH
Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated
medicare spending, drug indications, AA, FDA, medicare, ODAC
Medicare Parts B and D spent at least $569 million between 2017 and 2019 on 10 cancer drug indications without confirmed overall survival (OS) benefit after accelerated approval (AA). Approximately $224 million was spent on drug indications that were either voluntarily withdrawn or recommended fo…
Oct 18th • 5 mins read
Kyle A. Dymanus BS, Mohit Butaney MBBS, Diana E. Magee MD, MPH, MSc, Amanda E. Hird MD, MSc, Amy N. Luckenbaugh MD, Merry W. Ma MD, PhD, Mary E. Hall MD, Heather L. Huelster MD, Aaron A. Laviana MD, MBA, Nancy B. Davis MD, Martha K. Terris MD, Zachary Kla
Assessment of gender representation in clinical trials leading to FDA approval for oncology therapeutics between 2014 and 2019: A systematic review-based cohort study
clinical trials, drug approval, health care disparities, medical oncology, sexism
Gender representation in oncology clinical trials varies by cancer type, with women often underrepresented compared to national cancer incidence. Despite FDA guidelines from June 2015 requiring consideration of biological variables like sex in research designs, disparities persist. Women continu…
Jun 23rd • 8 mins read
Meena N Murugappan, PharmD, MPH, PhD(c), Bellinda L King-Kallimanis, PhD, Gregory H Reaman, MD, Vishal Bhatnagar, MD, Erica G Horodniceanu, MPH, Najat Bouchkouj, MD, Paul G Kluetz, MD
Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective
cancer, pediatrics, product labeling, united states food and drug administration, childhood cancer, denosumab, surrogate endpoints, adverse event, patient self-report, pediatric oncology, selumetinib, benefit-risk assessment, tisagenlecleucel, statistica
PROs have been feasible to collect from patients as young as 7 years old and were included in trials from 2013 onward. PROs were used as exploratory endpoints in four product applications but not included in product labeling. To include PRO data in FDA labeling, early interaction with the FDA, c…
Apr 30th • 12 mins read
Dylan V. Neel, MPhil, David S. Shulman, MD, and Steven G. DuBois, MD
Timing of first-in-child trials of FDA-approved oncology drugs
pediatric cancer; phase 1 trials; drug development; targeted therapy; disparity
Aim: To define the lag time between initial human studies and first-in-child clinical trials of oncology agents. Methods: Systematic analysis of time from first-in-human trials to first-in-child trials for agents approved by the FDA from 1997 to 2017. Dat…
Mar 18th • 10 mins read