Results for 'clinicians'
Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer
real-world evidence, real-world data, oncology, cancer, survey, clinicians, randomized controlled trials, Europe
Real-world evidence (RWE) is increasingly being used in the development and decision-making processes for anticancer therapies, but clinician views on its use are unclear. A survey conducted between May and July 2021 involved 557 clinicians from 30 countries and 13 cancer domains. Most clinician…
Aug 1st • 45 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
Stefanie Broes, Robbe Saesen, Denis Lacombe, Isabelle Huys
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer
European organisation for Research and Treatment of Cancer, EORTC, clinical research
Collaborations between academic institutions and industry have led to significant scientific breakthroughs in pharmaceutical research, particularly in the discovery phase. The role of multi-stakeholder partnerships in the clinical development of anticancer medicines requires further clarification…
Aug 16th • 8 mins read
Audrey D. Zhang, Jeremy Puthumana, Nicholas S. Downing, MD
Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
clinical trials, FDA, Novel therapeutic agents, biologics
The number of special regulatory programs for drug and biologic approvals by the FDA has increased since the introduction of the Fast Track designation in 1988. This study analyzed 273 new drugs and biologics approved by the FDA for 339 indications across three periods: 1995-1997, 2005-2007,…
Apr 21st • 20 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
Kenji Omae, Yuki Kataoka, Yasushi Tsujimoto, Yusuke Tsutsumi, Yosuke Yamamoto, Shunichi Fukuhara, Toshi A Furukawa
Publication statuses of clinical trials supporting FDA-approved immune checkpoint inhibitors: a meta-epidemiological investigation
Anticancer drugs, Clinical trials, Drug approval, Immune checkpoint inhibitors, Publications, United states food and drug administration
The study investigates the publication status of clinical trials for anticancer drugs approved by the FDA, focusing on immune checkpoint inhibitors (ICPis). Data from ICPis approved between 2011 and 2014 was analyzed, revealing that 58% of ICPis trials were published within two years …
Oct 24th • 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
oncology, guidelines, off-label drug use
The analysis reviewed 113 NCCN recommendations, focusing on 44 off-label uses of drugs. 14 of these off-label recommendations were later FDA-approved or backed by RCT data. 13 recommendations were minor extrapolations from the FDA label or actually on-label. Of the remaining 17 extrapolations…
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
IPD sharing, clinical trial transparency, FDA anticancer approvals, oncology trials, data accessibility, pharmaceutical industry
The study examines the eligibility for individual participant data (IPD) sharing from clinical trials that supported the FDA approval of anticancer medicines over the past 10 years. Of the 304 trials analyzed, 136 (45%) were eligible for IPD sharing, while 168 (55%) were not. IPD sharing rates v…
Jul 28th • 20 mins read
Envision Pharma Group
Medical affairs: The power behind redefining commercialization
Medical affairs commercialization, integrating science in pharma, redefining medical affairs roles, strategic medical affairs leadership, early engagement with payers, pharmaceutical commercialization strategies, upskilling in medical affairs, medical aff
In March 2024, Envision Pharma Group held a Medical Affairs Professional Society (MAPS) Americas roundtable with leaders discussing the role of science in commercialization strategies and the importance of integrating robust scientific understanding into the commercial journey. Envision revisite…
Aug 2nd • 3 mins read
Laurent Azoulay
Rationale, Strengths, and Limitations of Real-World Evidence in Oncology: A Canadian Review and Perspective
real-world evidence; RWE, real-world studies, RWS, oncology, real-world evidence, RWE, randomized controlled trial, RCT
Data obtained from real-world studies have an integral role in evidence-based medicine, serving as an essential source of safety information and a complement to efficacy data from RCTs. RWE is particularly useful for expanding the evidence base to encompass populations of patients who are not well r…
Apr 26th • 9 mins read
Sarah M. Dermody, Andrew G. Shuman
Implications of Research Biopsies in Clinical Trials
biopsies, clinical trials, oncology
Increased interest in noninvasive testing for treatment monitoring, tumor burden estimation, and disease recurrence prediction. Lower-risk research specimens and liquid biopsies (blood, saliva, urine) offer alternatives to invasive biopsies. Liquid biopsies present new privacy and risk considera…
Aug 31st • 2 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
Marc Thill, Nicholas Thatcher, Vladimir Hanes & Gary H. Lyman
Biosimilars: what the oncologist should know
biosimilars, extrapolation, monoclonal antibodies, oncologic biosimilars
As originator biologic medicines lose patent protection, biopharmaceutical companies are developing biosimilars. Biosimilars are similar versions of costly and complex therapies aimed at providing more affordable treatment options. Many biosimilars are now approved worldwide, with several m…
Dec 18th • 25 mins read
Envision Pharma Group
AI-powered real-world evidence: Strategically enhancing value and access
Oncology, Clinical Development, Targeted Therapy, Immunotherapy, Genomic Profiling, CAR-T Cell Therapy, Precision Medicine
Real-world evidence (RWE) complements traditional randomized controlled trials by providing insights from diverse data sources, helping healthcare decision-makers with coverage, reimbursement, and treatment guidelines. Artificial intelligence (AI) and natural language processing (NLP) are pivotal…
Aug 22nd • 5 mins read