Today’s video is another Google Hangout I conducted along with fellow Clinical Trials Guru Producers Darshan Kulkarni and Patrick Stone. During this super awesome interview, we discussed adaptive clinical trials, or the type of clinical trials that can change based on real time data analysis. For another blog post that I wrote on this topic, click here. Darshan in this video argues that adaptive trials may actually be too burdensome for the trend to actually catch on, while Pat and I discuss many of the potential benefits that these trials can and do provide to study participants. It’s none the less an interesting discussion that needs to be had and we expect to hear from you guys in the comments section below!
Posts tagged interview
I welcome Pat Stone, former FDA auditor and author of the must-read book “Bubble Gum Badge, an FDA His Story” to come on the show again and this time discuss the interesting development of remote or electronic monitoring. With the explosion of electronic medical records as well as case report forms in clinical trials recently, some Sponsors and CRO’s have began experimenting with remote monitoring, which in plain English means that the monitors do not need to actually do their monitoring visits on site. I have not had ANY experience with this at any of my research clinics yet, but I have heard both evangelists and critics alike share their feedback with me. I conducted another must watch interview with Anna Marquez about this very same issue about one year ago. In either case, this is definitely something to keep an eye out as the change to remote monitoring is practically inevitable. As always, I’m looking forward to your comments.
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.
Darshan Kulkarni from Kulkarni Law Firm came on the show today to shed some light of the recent Wellbutrin generic scandal in which the generic equivalent of the 300mg premium drug was not equally effective as the 150mg generic compared to its respective counterpart. In this interview we discussed what this may mean for clinical trials going forward, particularly the way generic clinical trials may be handled in the future as they will be closely watched by the FDA.
Today’s post comes courtesy of guest guru and Clinical Trials Guru Producer, Darshan Kulkarni of Kulkarni Law Firm. Darshan and I get into a viewer question in regards to a PI transferring his studies from one research company to another (perhaps his or her own company). As Darshan is a legal expert on these matters, I decided to let him get into some of the complications that one can run into under this scenario.