Results for 'Pivotal trial'
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
Mariam A. Ahmed, Chirag Patel, Nicole Drezner, Whitney Helms, Weiwei Tan, Daria Stypinski
Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development
drug development, healthy, volunteers, oncology clinical trial
The content discusses the challenges and opportunities in conducting oncology clinical trials, particularly focusing on trials involving normal healthy volunteers (NHVs) and patients with cancer. There are over 5,000 ongoing oncology trials in the U.S., with low enrollment rates among adult c…
Oct 31st • 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
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
Yafang Huanga, Weiyi Xiongb, Jingwei Zhaoa, Wentao Lia, Li Mac, Hao Wua
Early phase clinical trial played a critical role in the Food and Drug Administration-approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021
Early phase clinical trial, Dose-expansion cohort, Single-arm trial, Pivotal trial, FDA approved indications, Targeted anticancer drugs
Analysis of 188 FDA-approved indications for 95 molecular targeted anticancer drugs between 2012 and 2021. 59.6% of indications were approved based on Early Phase Clinical Trials (EPCTs). There was a notable annual increase of 22.2% in approvals based on EPCTs, compared to a 5.0% increase for ph…
Mar 9th • 10 mins read
Garth W. Strohbehn, MD, MPhil, Allen S. Lichter, MD and Mark J. Ratain, MD
US Government Payer-Funded Trials to Address Oncology's Drug-Dosing Conundrum: A Congressional Call to Action?
ORF, NCTN, dosing, clinical trials, FDA
Since the mid-20th century, cancer drug development has been driven by the "more is better" assumption, seeking the maximum tolerated dose in early trials. The FDA's Oncology Center of Excellence (OCE) Project Optimus (2021) requires dose optimization for new oncology drugs, but this does not…
Feb 13th • 5 mins read
Pan Pantziarka, Ciska Verbaanderd & Lydie Meheus
Biased by design? Clinical trials and patient benefit in oncology
clinical trial design, drug development, drug registration, patient benefit, risks of bias
The study by Naci et al. raises numerous questions relating to the design characteristics, risks of bias and reporting of pivotal clinical trials in oncology. These findings add to the existing body of evidence that suggests drug development in oncology is not delivering the clinical benef…
Nov 27th • 3 mins read
Janice Bonsu, MPH, Lawrence Charles, MD, Avirup Guha, MD, Farrukh Awan, MD, MS, Jennifer Woyach, MD, Vedat Yildiz, MS, Lai Wei, PhD, Hani Jneid, MD, and Daniel Addison, MD
Representation of Patients With Cardiovascular Disease in Pivotal Cancer Clinical Trials
cancer, cardiovascular disease, clinical trials, underrepresentation, United States Food and Drug Administration, FDA, CVD
Heart failure (28%) was the most common exclusion criterion in clinical trials for FDA-approved anticancer therapies, followed by prior coronary disease and arrhythmias (27% and 23%, respectively). Over one-third of trials excluded patients with underlying cardiovascular disease (CVD), including mor…
Mar 18th • 3 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
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
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
Patrick C. DeMartino, MD, Miloš D. Miljković, MD, MS, Vinay Prasad, MD
Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018
FDA, drug approvals, oncology, cancer drugs
The new, expensive cancer drugs approved by the FDA in 2018 could drastically increase U.S. healthcare spending if widely adopted, but industry forecasts suggest low-level market uptake, maintaining current budget trends. The healthcare system's financial stability partially relies on many eligible …
Aug 31st • 7 mins read