Results for 'outcomes'
Tanja Cufer, Tudor E. Ciuleanu, Peter Berzinec, Gabriela Galffy, Marko Jakopovic, Jacek Jassem, Dragana Jovanovic, Zhasmina Mihaylova, Gyula Ostoros, Christiane Thallinger, Milada Zemanova, Christoph Zielinski
Access to Novel Drugs for Non-Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
Health Outcomes and Economics of Cancer Care, Lung Cancer, NSCLC, EMA
Treatment for non-small cell lung cancer (NSCLC) has significantly improved with the introduction of targeted and immune-oncologic drugs. Despite rapid development and European Medicinal Agency (EMA) registration, these novel drugs are not easily accessible in Central and Eastern European (CEE) c…
Nov 24th • 10 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
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
Aviv Ladanie, PhD, Andreas M. Schmitt, MD, Benjamin Speich, PhD, Florian Naudet, PhD, Arnav Agarwal, MD, Tiago V. Pereira, PhD, Francesco Sclafani, PhD, Amanda K. Herbrand, MD, Matthias Briel, MD, MSc, Juan Martin-Liberal, PhD, Thomas Schmid, MD, Hannah E
Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016
cancer treatment outcomes, outcomes, drug approval, clinical data, FDA
Data from 17 years of studies on novel cancer drugs show limited information available at market entry. Randomized Controlled Trials (RCTs) data are available for only half of the drug indications. Lack of data is particularly problematic for patients with hematological cancers. Novel therapies…
Nov 10th • 6 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
Alfredo Addeo, MD; Glen J. Weiss, MD, MBA; Bishal Gyawali, MD, PhD
Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival: A Pooled Analysis
pooled analysis, FDA, negative phase 3 trials, phase 3 trial, RCT, PRISMA, RCT's
In this study of trials published in 2016 through 2018, approximately 40% of negative phase 3 RCTs in oncology were conducted without supporting phase 2 trials, and such phase 3 trials were sponsored by both academia and industry. On the basis of our results, proactive steps from regulators and ethi…
May 10th • 8 mins read
Tom Caravela
Interview Differentiator-Be a Story Teller
interview preparation, effective interviewing, behavioral interview questions, storytelling in interviews, successful interview techniques
When you search Google for the words “Interview Preparation,” you will come up with approximately 756,000,000 results. While I am sure you can find an abundance of valuable information, it is very difficult to navigate through all of the content available on the Internet to determine wha…
Mar 22nd • 1 min read
Tom Caravela
Job Search Checklist for Aspiring Medical Science Liaisons
Medical Science Liaison, MSL role, MSL career tips, Pharmaceutical industry jobs, Break into MSL career
Tips to Help Break into Your First MSL Role The Medical Science Liaison (MSL) role, has become one of the most sought-after career paths in the Pharmaceutical and Biotech industry. What does it take to land a role as a Medical Science Liaison? As an MSL Recruiter, this is a question that I am…
May 17th • 2 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
Tom Caravela
MSL People Skills: Top 10 Tips for Better Engagement
Medical Science Liaison, relationship building, business etiquette, social awareness, emotional intelligence, professional interactions, Dale Carnegie, How to Win Friends and Influence People, professional brand, engagement tips, digital communication
The cornerstone of the Medical Science Liaison role is RELATIONSHIP BUILDING. In a nutshell, better engagement equates to better relationships. The purpose of this article is to address the importance of proper business etiquette and the impact of social awareness and emotional intelligence as it re…
Apr 20th • 8 mins 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
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
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
E.M. Ray, L.A. Carey, K.E. Reeder-Hayes
Leveraging existing data to contextualize phase II clinical trial findings in oncology
HER2, phase II trials, oncology, iDFS, EBC, early stage breast cancer
In the USA, over 250,000 women are diagnosed with early-stage breast cancer (EBC) yearly, with up to 30% having HER2 amplification. The standard care for HER2-positive EBC involves chemotherapy plus HER2-directed therapy for one year. The phase II Adjuvant Paclitaxel and Trastuzumab (APT) tr…
Sep 21st • 3 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
Nidal Al-Huniti, Yan Feng, Jingyu (Jerry) Yu, Zheng Lu, Mario Nagase, Diansong Zhou, Jennifer Sheng
Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA
Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…
Jun 26th • 18 mins read
Dylan V Neel, David S Shulman, Clement Ma, Florence Bourgeois, Steven G DuBois
Sponsorship of oncology clinical trials in the United States according to age of eligibility
clinical trials, industry, oncology, pediatric, sponsorship
The sponsorship mix of trials relevant to young people with cancer has not been well-documented, which may impact policies and regulations in pediatric cancer drug development. An analysis of interventional trials in the U.S. from 2007 to 2018 was conducted using the ClinicalTrials.gov registry, …
Apr 29th • 8 mins read
Massimo Di Maio, Francesco Perrone, Pierfranco Conte
Real-World Evidence in Oncology: Opportunities and Limitations
Real‐world evidence, Clinical trials, Cancer treatments
Randomized controlled trials (RCTs) are traditionally viewed as the gold standard for evaluating treatment efficacy, but real-world evidence (RWE) is gaining traction in oncology for addressing questions not fully answered by RCTs. RWE is derived from health records, cancer registries, and other …
Dec 24th • 8 mins read
Jakub P. Hlávka, PhD, Pei-Jung Lin, PhD, Peter J. Neumann, ScD
Outcome measures for oncology alternative payment models: practical considerations and recommendations
This paper focuses on synthesizing existing research on quality measures in oncology, particularly outcome-based quality measures which are underutilized. A set of "core outcome measures" is proposed for future oncology alternative payment models (APM). The study design includes a literature rev…
Dec 1st • 10 mins read
Jonathan H. Cheng, Justin W. Tiulim, Sheng Zhou, Anthony El-Khoueiry and Jorge Nieva
Mandatory Research Biopsy Requirements Delay Initiation of Clinical Trials
biomarker, clinical trial, targeted therapy, immunotherapy, mandatory research biopsy, oncology, lung cancer, head and neck cancer
The study investigates the impact of requiring fresh tumor tissue biopsies for enrollment in clinical trials. Key findings include: Requiring biopsies significantly increases screening duration, with a median of 30 days compared to 14 days for trials without biopsy requirements (p < 0.0001). …
Oct 18th • 10 mins read