Results for 'commitment management'
Tom Caravela
iNIZIO
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
Apr 20th • 8 mins read
Emmanuelle Jacqueta, Ghania Kerouani-Lafayeb, Francoise Grudeb, Sergio Goncalvesb, Annie Lorenced, Florence Turcryb, Liora Brunelb, Laetitia Belgodereb, Adrien Monardc, Gaëlle Guyaderb, Lotfi Boudalib, Nicolas Albin
Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years
Apr 7th • 12 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
Jun 26th • 18 mins read
R. Kurzrock, L.A. Gurski, R.W. Carlson, D.S. Ettinger, S.M. Horwitz, S.K. Kumar, L. Million, M. von Mehren, A.B. Benson III
Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals
Aug 2nd • 8 mins read
Natansh D. Modi, BPharm; Ahmad Y. Abuhelwa, PhD; Ross A. McKinnon, PhD
Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
Jul 28th • 20 mins read
Deeksha Joshi, Rubiya Khursheed, Saurabh Gupta, Diksha Wadhwa, Thakur Gurjeet Singh, Sumit Sharma, Sejal Porwal, Swati Gauniyal, Sukriti Vishwas, Sanjay Goyal, Gaurav Gupta, Rajaraman D. Eri, Kylie A. Williams, Kamal Dua, Sachin Kumar Singh
Biosimilars in Oncology: Latest Trends and Regulatory Status
Dec 5th • 20 mins read
Envision Pharma Group
Medical affairs: The power behind redefining commercialization
Aug 2nd • 3 mins read
Envision Pharma Group
Empowering people to drive medical affairs performance with AI
Aug 14th • 5 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
Jun 7th • 8 mins read
Sarah M. Dermody, Andrew G. Shuman
Implications of Research Biopsies in Clinical Trials
Aug 31st • 2 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
May 5th • 12 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
Apr 30th • 12 mins read
Jason J. Yang, BS Naomi So, MD Nolan J. Maloney, MD Julia Arzeno, MD Katherine K. Clifton, MD Daniel Q. Bach, MD, MPH
Inadequate and delayed characterization of cutaneous reactions for US Food and Drug Administration-approved oncologic drugs from 2011-2020 leading to medication discontinuation
Oct 23rd • 4 mins read
G. Pentheroudakis
Recent eUpdates to the ESMO Clinical Practice Guidelines on hepatocellular carcinoma, cancer of the pancreas, soft tissue and visceral sarcomas, cancer of the prostate and gastric cancer
Jun 6th • 2 mins read
Emerson Y. Chen, MD, Vikram Raghunathan, MD, Vinay Prasad, MD, MPH
An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate
May 28th • 5 mins read
Stephanie Faucette, Santosh Wagh, Ashit Trivedi, Karthik Venkatakrishnan, Neeraj Gupta
Reverse Translation of US Food and Drug Administration Reviews of Oncology New Molecular Entities Approved in 2011-2017: Lessons Learned for Anticancer Drug Development
Mar 11th • 15 mins read
