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 safety
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.
Throughout the various emails I receive on a daily basis from clinical research sites worldwide, one of the top questions I get asked is where can we get some quality free clinical trial training. I have been stressing the importance of GCP (good clinical practice) training since Day 1 of this site. I also know the importance of having adequate hazardous good shipping training (also known as IATA) as I understand that many study coordinators are also responsible for processing and shipping lab samples for the various study protocols that they manage. Finally, we all need to make sure that we cover study participant safety and protection, so I found a great link from the NIH to cover this topic. Well without any further delay, I bring you 3 different and most important, FREE, training links that cover GCP, IATA, and finally Protecting Human subjects in research. All these trainings come complete with a certificate of completion for documentation purposes.
1.)GCP training Quintiles’ website
3.)NIH Protecting Human Subjects
Please note that other trainings do exist both online and offline and the costs vary greatly. The above 3 links are trainings that I have used for my research clinics as well as trainings that I refer to other clinics when they ask me about free trainings. It is important to understand that I get absolutely nothing from these 3 vendors for promoting these links, I am just a fan of their services. While numbers 2 and 3 (IATA and NIH Protection) are very straightforward, the GCP training (#1) is very tedious and may be overwhelming for someone brand new to research. If you would like to support me, I have created and Introduction To Clinical Research DVD that has been very well received in the industry as I have condensed the most critical components of clinical trials in an easy to understand manner. Here is the link to my training DVD which also comes with a certificate of completion for documentation purposes. With these four training resources, anyone new to clinical trials, or anyone seeking a refresher on expired training, will hopefully not be disappointed. Let me know if this was helpful and feel free to share more training resources in the comments section.
Why choose to participate in clinical trials…is it REALLY about the money?
A word about paid studies. Let’s face it, many people that I’ve run across, not only at my own clinic, but also at industry conventions and other such events, choose to do studies for the payments. This especially becomes evident in phase 1, healthy volunteer studies, where the study participants jokingly refer to themselves as “professional guinea pigs”.
I would just like to say that while there is nothing necessarily wrong with doing studies primarily for the payment, many people, especially those in phase 2-4 studies, don’t consider payment the primary reason for doing studies. For many people that I’ve come across, traditional therapies that are already available on the market do not work as well as previously anticipated, and these people seek newer treatments, not yet available to the public, via clinical trials. In cases such as these, payment becomes a mere afterthought, and the treatment of the disorder or disease become the primary motivator. Furthermore, many patients feel as though they actually receive better medical attention when they participate in studies. This may be true in many cases, as some outpatient study visits may take anywhere from 1-4 hours, and all bases are pretty much covered in terms of a clinical perspective (vital signs, labwork, ECG’s, MRI’s, CT Scans, quality of life surveys, etc).
Many of these procedures, while often important, will never get recommended in a non-study setting due to ever increasing pressure from insurance companies to keep costs down, however in a study, these procedures would never be overlooked. This may be a sign of the times, and evidence of how broken our medical system actually is.
So I got a great question this week and decided to do a video and blog post on it. It is in regards to the proper way as per GCP (good clinical practice) standards, for withdrawing study participants from a clinical trial. Whether a study participant has just finished a study as per the protocol, or whether the participant has to be withdrawn from the study due to a safety reason or possible side effect from the clinical trial, there is a certain procedure for doing this. The Principal Investigator and study staff must inform the subject as to why they are being withdrawn, and furthermore, must be given a copy of the lab results or some other type of documentation that the participant can take to their primary care physician or medical specialist for further follow up. The PI or study staff must do everything they can to inform the physician that the participant will see and follow up to ensure that the treating physician is informed of the study participant’s medical condition as well as side effect from the clinical trial study drug or any other abnormal finding. Furthermore, the study participant must be followed up for a period of time to document the end result of the condition or lab value which caused the participant to be withdrawn from the study. To learn more about what happens when a participant gets a side effect in a clinical trial, especially from the perspective of a trial participant, check out this video I did earlier.