Results for 'eligibility'
A. Haslam, M.S. Kim, V. Prasad
Updated estimates of eligibility for and response to genome-targeted oncology drugs among US cancer patients, 2006-2020
genome-targeted therapy, eligibility, response
Recent studies have been conducted to update the estimates of eligibility and response rates to genome-targeted therapies among US cancer patients, reflecting data up to 2020. The number of FDA-approved drugs targeting genetic indications has increased significantly since prior assessments. …
Apr 20th • 7 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
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
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
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
Jonathon Webster, MD and B. Douglas Smith, MD
The Case for Real-world Evidence in the Future of Clinical Research on Chronic Myeloid Leukemia
Real world data, FDA, RCT, RWE, RWD
In light of recently published guidelines from the US Food and Drug Administration (FDA) on the communication of real-world data (RWD) and real-world evidence (RWE) to support regulatory decision making, it is important to understand the following key points and concepts: Development of RWD and R…
Jan 29th • 10 mins read