A New Clinical Trial Design Promises to Accelerate Cancer Drug Approvals
The Food and Drug Administration (FDA) has drafted a regulatory guidance describing a new way of conducting breast cancer drug trials that promises to reduce substantially the time and cost of getting new treatments to patients. The approach is based on a trial design being tested in the I-SPY 2 TRIAL, an innovative Phase II breast cancer trial being conducted under the auspices of the Biomarkers Consortium, a public-private partnership led by the Foundation for the National Institutes of Health (FNIH) that includes representatives from NIH, FDA, and multiple pharmaceutical companies and academic research centers.
Patients with early-stage breast cancer have typically had to wait for years to receive new cancer drugs, which are usually tested first in patients with later stage metastatic disease and approved for use in more curable early stage cancer only after additional randomized clinical trials. The draft guidance, which is described in the current issue of the New England Journal of Medicine, establishes a potential new pathway for accelerated approval of drugs tested prior to surgical removal of tumors in certain types of high-risk patients with localized, early-stage disease. FDA signaled it may now grant approval of new drugs that have shown clinical benefit, based on data from patients receiving this type of ³neoadjuvant² treatment whose invasive cancer has disappeared by the time of surgery (³pathologic complete response²).
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
