There is significant lack of diversity in clinical trial populations. FDA approved 67 new drugs in 2015 and 2016, and of the total trial populations, 5-7% were African-Americans, 11-12% were Asians, while 76-79% were White. Women were more equally represented with about 40-48% study populations being female. The situation was worse in certain indications like … Read more
Recently “Right to Try” bills were introduced in the US Senate and Congress. Similar laws have been enacted in 33 states; however it was felt that creating a Federal law will have a stronger impact in getting companies to give experiment drugs to terminally ill patients. While the intent behind the bills is great, the … Read more
Adverse event monitoring in clinical trials can be automated and revolutionized using wearable medical devices as indicated by a recent study. The study showed that data collected using wearable devices to monitor physiological changes can be exploited to identify illness and other changes in health status over time. There are no surprises here but this … Read more
Most discussions about data integrity revolve around misconduct by sponsors and CROs. An often silent topic is fraud by patients participating in trials. Recently there were reports of extensive fraud by subjects participating in Phase 1 clinical trials in China. Subjects would routinely manipulate biological samples, use fake IDs to get around recruitment restrictions, and … Read more
Peer-reviewed publication of clinical trial results, expert opinions and patient advocacy groups are frequently used to support market approval of drugs and public policy discussions. A series of articles published last week raise serious questions about the conflict of interest issues in such information. Major aspects of public discussions involving new drugs may be tainted … Read more
Starting 5 May 2017, FDA will require all DMFs be submitted only in the electronic CTD format creating a huge burden on owners of non-critical DMFs. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. To avoid the hassle of converting to eCTD format, … Read more
A GAO report on FDA’s foreign inspections paints a very dire picture for the current status of inspections. There are about 5000 manufacturing sites registered with FDA of which 3000 are located outside of the US; about 1000 of these foreign sites have never seen an FDA audit. With about 40% of finished products and … Read more
Data collected from doctors, medical records, insurance claims databases and patient registries regarding use of medical products and disease conditions, called “Real World Evidence”, is often claimed to be reliable, robust and credible enough to support regulatory decisions. The 21st Century Cures Act requires FDA to create a process to use Real World Evidence (RWE) … Read more
Like any other internet-connected device, medical devices can be hacked, and the hacked device used to harm the individual dependent on it. Imagine someone controlling the pacemaker embedded in your body or the infusion pump giving you life-support. It’s no different from someone pointing a gun to your head, with similar outcome. The possibility no … Read more
Contrary to popular belief, most of what FDA does is not influenced much by political changes. The Agency has exhibited remarkable bipartisan support for most of its mandates, and exceptional resilience for almost all its activities. FDA review processes, compliance verification processes, most project management activities, safety monitoring activities, and most regulatory decisions affecting the … Read more
