Results for 'E-R analyses'
Browse oncology articles matching E-R analyses — 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.
Sonoko Kawakatsu, René Bruno, Matts Kågedal, Chunze Li, Sandhya Girish, Amita Joshi, Benjamin Wu
Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology
monoclonal antibodies, E-R analyses, tumour growth inhibition, drug development
Dose selection and optimization is crucial in drug development to maximize benefits for all patients. Exposure–response (E-R) analysis is useful for dose-selection strategy, but in oncology, prognostic factors can confound the analysis, especially for monoclonal antibodies. The review addr…
Nov 20th • 12 mins read
Daan Geert Knapen, Nathan I. Cherny, Panagiota Zygoura, Nicola Jane Latino, Jean-Yves Douillard, Urania Dafni, Elisabeth G.E. de Vries, Derk Jan de Groot
Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1
ESMO-MCBS, early colon cancer, toxicity, adjuvant chemotherapy, quality of life
Form 1 of the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is used to grade therapies with curative intent. The study aimed to evaluate the applicability and reasonableness of the ESMO-MCBS scores in early colon cancer. Adjuvant studies were sourced f…
Sep 6th • 17 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
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
Ruben Van Paemel, Roos Vlug, Katleen De Preter, Nadine Van Roy, Frank Speleman, Leen Willems, Tim Lammens, Geneviève Laureys, Gudrun Schleiermacher, Godelieve A. M. Tytgat, Kathy Astrahantseff, Hedwig Deubzer, Bram De Wilde
The pitfalls and promise of liquid biopsies for diagnosing and treating solid tumors in children: a review
Liquid biopsies, Pediatric solid tumors, Cell-free DNA profiling
Cell-free DNA profiling via blood samples is emerging as a non-invasive method for cancer genomic characterization. Liquid biopsies are set to be integrated into pediatric cancer clinical trials, offering benefits such as earlier therapy response monitoring and detection of residual disease.…
Jan 3rd • 10 mins read
Idine Mousavi, BA; Timothée Olivier, MD; Vinay Prasad, MD, MPH
Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022
anticancer drugs, adjuvant therapy, FDA approvals, cost per event averted, surrogate endpoints, oncology drug costs
Importance: Evaluating the cost-effectiveness of adjuvant therapies based on the cost per event averted. Objective: To assess the costs per event averted for anticancer drugs approved by the FDA between January 2018 and March 2022. Design, Setting, and Participants: Cross-sectional study of F…
Jun 10th • 30 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
Robbe Saesen, Mieke Van Hemelrijck, Jan Bogaerts, Christopher M. Booth, Jan J. Cornelissen, Andre Dekker, Elizabeth A. Eisenhauer, André Freitas, Alessandro Gronchi, Miguel A. Hernán, Frank Hulstaert, Piet Ost, Petr Szturz, Helena M. Verkooijen, Michael W
Defining the role of real-world data in cancer clinical research: The position of the
real-world data, real-world evidence, randomised, pragmatic trials, cancer, clinical research, add-on cohorts
Real-World Data (RWD) are increasingly used in cancer clinical research as an alternative evidence source. RWD studies primarily involve observational data, which offer insights into real-world conditions but may have quality limitations. Some research questions necessitate Randomized Controlled…
Mar 20th • 10 mins read
Nora Hutchinson, MD, CM, MPhil, Benjamin Carlisle, PhD, Adelaide Doussau, MD, PhD
Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration
clinical trials, biologics, FDA approval, drug development
The study provides a crucial understanding of the role and impact of patient contributions in oncology drug development, focusing on their association with clinically impactful drug outcomes. Successful oncology drugs required an average of 12,217 patients in pre-license trials, with higher numbers …
May 18th • 5 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
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, sponsor, pediatric clinical trials, sponsorship
The analysis focuses on the sponsorship of interventional oncology trials for patients under 18 in the U.S. There are fewer industry-sponsored trials for pediatric oncology compared to adult trials and other pediatric disciplines. Industry-sponsored trials tend to be phase III, enroll more patie…
Apr 29th • 6 mins read