New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
The FDA’s device center has published two guidances dealing with patient engagement in relation to the conduct of clinical trials, including a final guidance for patient input into clinical trial design. The final guidance is mum, however, as to whether consultations with patient representatives constitutes a violation of the Anti-Kickback Statute (AKS), a predicament the Advanced Medical Technology Association (AdvaMed) said may represent a serious legal hazard for device makers.
LONDON – A pledge to “bottle” improvements made in setting up and running clinical trials during the pandemic has materialized in the formation of Protas Ltd., a nonprofit promising to stage large-scale phase III clinical trials in common diseases for less than one tenth the current cost. Protas will design and run randomized phase III studies of new and repurposed drugs in conditions including depression, dementia, heart, lung and respiratory conditions, arthritis and cancer.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) unveiled a proposal to overhaul its requirements for clinical trials for drugs and devices, just one of several significant regulatory proposals in recent months. One of the proposed changes would be to require more patient engagement in the design of trials, while another feature would allow sponsors to go through the MHRA process and an ethics review in a single application, thus potentially streamlining the up-front work required for these studies.
Hoping to improve Europe’s clinical trial environment, EU officials launched an initiative Jan. 13 to transform how clinical trials are designed and conducted.
It is acknowledged that the huge bias toward individuals of European ancestry means studies of the contribution of genetics to disease may not translate well to other ethnicities. That point is underlined in the first large-scale investigation of the population structure and demographic history of British Pakistanis, which shows an increased number and length of regions of homozygosity inherited from a common ancestor, and greatly elevated identity by descent, compared to the population at large.
The FDA has delivered on a final guidance for non-clinical and clinical investigations of devices used for treatment of benign prostatic hyperplasia (BPH), needing only a year and a half to convert the draft guidance into a final version. The final guidance retains the draft’s recommendation that pivotal studies follow patients for at least a year, a provision some in the med-tech industry saw as unnecessary in some instances. The scope of the July 2020 draft included non-clinical testing, a novelty compared to previous guidance on the topic. The scope of this latest guidance includes four product codes, including KNS for endoscopic electrosurgical instruments, and the FDA included several specific suggestions for the use of thermotherapy and permanent prostatic stents as treatments for BPH.
