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 21^st • 20 mins read

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 26^th • 9 mins read

Cancer research in the United States: A critical review of current status and proposal for alternative models

cancer research, research, NCI, Drug industry-driven research model, development in research, 2018 cancer model

Early research focused on tissue histology and animal models, with surgery and radiotherapy as primary treatments. 1950s: Introduction of cell lines (e.g., HeLa cells) and first anticancer drugs (antifolates, thiopurines), leading to the establishment of the Cancer Chemotherapy National Service C…

May 14^th • 10 mins read