The title of this blog post sums it up. Keep your questions rolling in!!!!
The problem with most study file record retention issues in clinical research has to deal with the fact that no matter who you ask for answers, it seems that all you will get are more questions. I decided to do a video on this topic as it is a question that still gets asked all the time in this industry. Please remember that this is just my personal opinion, and when in doubt, contact your study Sponsor for their particular recommendations.
I was fortunate enough to finally meet Pat Stone, the former FDA auditor who has appeared on this blog many times throughout the years. In this interview Pat and I discuss how risk based monitoring is being viewed by the FDA and why many in the industry believe that monitoring has been really sloppy as of late. There were many interesting things that I learned during this mini-interview but the most striking was probably the fact that Sponsors routinely report CRO’s to the FDA anonymously for lackluster clinical trial management! This would add some further support to my theory that Sponsors are using this time of low study activities to square off CRO’s against each other and see who can perform better. I could not believe this, but apparently it occurs quite a bit. There are many other insightful findings here and I hope you find a few helpful.
In today’s video I share some anecdotal evidence of a particular trend I am seeing as of late in clinical research: Sponsors choosing two CRO’s to conduct virtually the same protocol and then, through risk-based monitoring, assessing which protocol they want to stick with (if any) and which study they will cancel. I have seen this personally occur three times this year while hearing the same from others in the industry at both the research site and CRO level. I do not believe this is a long term trend, rather I see this as a direct result of the relatively low supply of clinical trials this year and the high demand amongst CRO’s to want to win these studies. When study activity picks up next year, I think we will see less of this but at least for now, this is what we have to deal with.
In this week’s video/podcast I cover a multitude of topics and get back to a bunch of viewer emails. The usual topics such as negotiating budgets and getting more studies are covered, but my favorite this week was a Site that almost turned down a study because their Principal Investigator din’t want to go to the Investigator Meeting! Under no circumstance should you ever do this. It is actually quite common for PI’s to refuse to go to IM’s, and while it may not look great for the Site, you will not lose the study. I hope you enjoy this video, and keep the questions rolling!
In this video I answer a viewer question on what are some of the best ways to pay patient recruiters or even business development staff. Hope it is helpful!