6 Components of a Clinical Trial Transparency Program

Major: Hey guys, welcome to the DarshanTalks Podcast. Today, we're going to be talking about the six components of a clinical trial transparency program. My name is Major Hoffman and I'm here with Darshan Kulkarni. Darshan: Yep. That's still my name. Narrator: Good. Just double checking. This is the Darshan Talks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @darshantalks, or the show's website at darshantalks.com. Major: Darshan, can you briefly go over why you would need a clinical trial transparency program? Darshan: So, one of the big reasons you want a clinical trial transparency program is because you're legally required to actually disclose... Components of having a clinical trial transparency program are legally required. So, if that's part of it, you might as well have a system around it, so that it's comprehensive, and you aren't trying to reinvent the wheel every single time. So, that's one big reason. Another reason to do it is because it's the right thing to do. And you might want to do this because you're being a patient centric organization, and that's often the core values of a lot of different companies. And you might also be looking at having a clinical trial transparency program because it's trying to figure out how this fits into some of the other components that you're already managing. So, we can have a whole discussion about this, but those are some initial jump off considerations as to why [crosstalk 00:01:23]. Major: Right, I'm sure someone's like, we need to have a clinical trial transparency program, and I think in a previous discussion, you and I said or you mentioned this, this can be considered to be monolithic, and it doesn't have to be like that. And that's what we're trying to get into. Is theirs, out of all the different components or you've summarized those, or you've collectively put them in a list of six components of a clinical trial transparency program. So, without further ado, what is number one? Darshan: So, the reason I mentioned a model, is most people think I want to have a clinical trial transparency program, and I have an answer to it. They think it's a question with a direct answer. Unfortunately, like we mentioned, there are at least six different components, and these six different components may have different answers. Each component may have a different answer than when compared to someone else. So, don't think of it as a monolith. Think of it as a jigsaw puzzle, and only you know what that final picture needs to look like. So, the first component to that is a requirement if you are conducting studies, for example, in the U.S. or have U.S. implications, or using U.S. patients. You need to actually register your study depending on which type of study it is, under clinicaltrials.gov, which is the main website most companies use. So, it's clinicaltrials.gov. You also have the European version, which is EUDRACT, and that's E-U-D-R-A-CT. The EUDRACT website is not as active as the clinicaltrials.gov website. I think the last time I looked at it in one year, EUDRACT had something like 1500 studies and that same year clinicaltrials.gov had something like 19,000 studies. Major: When you say clinical trial registration, do you mean registration of the clinical trial or clinical trial of participants in that clinical trial? Darshan: So, what I'm talking about is the registration of the study that the study exists. So, this might actually be a tool for patients to register and say that I want to be part of the clinical trial, but this is not the place you'd go to, to register as a patient. It simply is where you go to, to say, I have a study. The second one is actually having a result.