In this conversational style interview and Google Hangout where yours truly joins the discussion fashionably late (28 minute mark), Darshan Kulkarni and Patrick Stone, two of our very own Clinical Trials Guru Producers, get into the topic of drug compounding. Compounding has been in the news a lot lately due to some unfortunate incidents in which we discovered that regulation of this sub-industry may not have been ideal. Towards the end of this interview, where I join in on the conversation, we get into FDA audits, and more specifically, how to handle “war rooms” should your company ever encounter an FDA audit.
Posts tagged side effects
Had on the one and only Pat Stone today. Pat is a former FDA auditor, consultant and author of a fantastic book, Bubble Gum Badge, and FDA His Story”. In this interview Pat and I discuss CRA’s or monitors in the clinical research industry and how, this year in particular, they are busier than ever. Sounds good so far right? Well it turns out that these CRA’s are too busy and are jumping from CRO to CRO in order to alleviate their burdensome workloads and look for some type of stability for their work-life balance. As Pat and I discuss, this interesting phenomenon has caused delayed payments to sites in some cases as well as some adverse events not being properly reported from various studies. We then discuss how the FDA is beginning to look at this issue just now. Let me know what you think about this in the comments below.
As I have written about before, while China is preparing to be the biggest pharmaceutical market in the world by 2020, the Chinese government will most likely put in place much stricter safeguards as early as this year to protect its roughly half a million study participants (yearly figure). According to this story from China Daily, an elderly woman participating in a clinical trial sponsored by Bayer Pharmaceuticals, developed serious side effects while on the inpatient unit for the clinical trial. These side effects required her to withdraw from the study and enter the hospital as a patient at which point, the hospital’s mandated insurance to cover clinical trial adverse events would not cover more than $530 US dollars whereas her true medical costs amounted to be around $194,000 US dollars.
This story, much more than an isolated incident, is serving as a wake up call to Chinese regulatory agencies as well as US and European drugmakers who have been expanding into China like crazy these past few years in hopes of establishing their clinical research infrastructure and preparing to capitalize on this large drug market as the local economy improves and the demand for pharmaceutical compounds is on the rise.
US and European drugmakers found themselves in a similar situation last year in India, as the Indian Supreme Court got involved in order to prevent any further cases of study participants not being compensated for their clinical trial adverse effects. Partly due to this reaction by Indian regulatory agencies and partly due to China’s promising future as a nation of consumers, many of these firms continued their expansion further East and settled into China. Well now it is looking like the regulations in China will begin changing as well as it pertains to clinical research and US and European drug makers will have to adapt yet again.
Today I am very glad to have Patrick Stone on the show once again. Pat is a former FDA auditor and current consultant who has written the book “Bubble Gum Badge” which I consider a must read for anyone interested in the world of clinical trials. In this video, Pat and I discuss GMP, or Good Manufacturing Practices, and how the FDA is tightening up its regulations on how drugs are manufactured. We even get into how many supplement companies are having to get their acts together as far as conducting clinical trials and even how they manufacture their products. Overall, an excellent interview that I hope you guys can take some value from.
Today I made a video for a study participant who sent me an email asking where he can find an inpatient healthy volunteer study in order to pick up some extra income. The first website I recommend he check out is Just Another Lab Rat which is a good site despite me not necessarily agreeing with the name, I understand that it is a catchy title that can generate lots of attention. I actually tried to interview the founder of JALR on this website but so far I have been (politely) turned down. In either case, I like to create videos for study participants from time to time and in regards to Phase 1 healthy volunteer studies, I have actually done quite a few videos and interviews with former study participants on this topic. Here is a good one, with author of the controversial book “The Professional Guinea Pig”. Here is one where I interview a healthy volunteer study participant. Finally, here is one where I interviewed a study participant while he was actually in an inpatient unit although my tech skills at the time were not so great as I did not have Skype call recorder yet, it was an old school cell-phone speakerphone interview, but nonetheless, it was a good interview.