What a Clinical Trial Transparency Program Is (and Why You Need One)

Major: This is the Darshan Talks Podcast. Today, we're going to be talking about why do you need a clinical trial transparency program? I hit that right or was it a strategy involved in that somehow, Darshan? Darshan: No, it's really going into why you need it in the first place. Narrator: 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. Darshan: You've sort of done a couple of podcasts on how do you do it right? And what are some components of it? But a really good question, a really good basic question that we probably need to answer is why even bother having one? And I think the number one reason is because legally from a legal and regulatory perspective which is what matters to a lot of companies, you're required to have a way of actually disclosing a lot of the results associated with this. So you need to have an overall strategy so that you aren't reinventing the wheel each time. So that's number one, just to meet legal regulatory requirements. Major: Oh, we're making a list on this one okay. Darshan: Yeah. Major: So number one don't reinvent the wheel every time. Darshan: Exactly, right. Number two, because you need to understand if you're developing other programs whether it's a publication program, whether it's a privacy program, how does all this connect to your transparency program? Because if you're going to say that we're not going to disclose anything well, what does anything mean? Because you may be required to disclose things under your... So if your privacy program says, I won't disclose anything, but your transparency program lands up requiring you to disclose things it's best to get those both out simultaneously so that you have a clear process on how it's going to happen. Number three, because it's often just the right thing to do, because you've got a situation where you've got patients and participants who are often engaging with you early on during your entire development process, they're helping you understand what is expected. They're helping you be part of your products development strategy. They're helping you recruit new patients, new subjects and when all of that is happening and they're often risking their life participate in your study depending on what type of study it is. It's only right that they be able to get the results, they have an understanding of what studies are happening and that patient-centricity becomes a core goal of your process. So I think that was number three was it? Major: Yes. Darshan: Okay. So another- Major: So just to go over what we just went over. Number one, don't re-- why you need a clinical trial transparency program? Number one, don't reinvent the wheel every time so you don't have to do that. Number two, you need to answer the question, how does this connect to your transparency program? And if your transparency program requires disclosure, you want to do that. And number three, it's just the right thing to do. Darshan: Yeah. Another reason you might want to have a transparency program is because you are developing an overall strategy and you're going into different countries and you need to be able to understand what that country's expectations are and you're looking to publish in the journals associated with those countries. So if you're doing that, you need to understand what those requirements are. So if you don't have a transparency strategy, you're going to be reinventing and creating a new paragraph for the overall strategy each time. And we've seen clients do this before, where general X will say, "What is your transparency program?