Clinical Trial Transparency Strategy: 6 Things to Consider

Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. Today, we're going to talk about six considerations in creating a clinical trial transparency strategy. Narrator: This is the DarshanTalks 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, kick it off with number one. Darshan: Yeah. So, well, I think the biggest problem most people have when they're creating a transparency strategy is they start putting the cart before the horse and they start going, "Do you have a template I can use?" And that's actually problematic because whoever's giving you a template needs to understand why you're doing what you're doing. Major: These templates are online. It's also like what they've done previously in other scenarios and what they've also advised on, right? It's not just- Darshan: Yeah, so sometimes it's competitors, what have competitors done. And they'll sort of point to that and just wholesale take that template. Except your competitors are working their own problem. What's that? Major: Why shouldn't they just look at a competitor and say, "You know what, I like what they're doing. Why can't I just do that? And let's move on. Let's go to the next step." Darshan: We'll actually talk about... Well, let's talk about that. So when you're talking about competitors, competitors are often, first of all, they have their own considerations. So they might be a different size. They may be dealing with different patient populations. They may be working with a different market cap. They might be privately held versus publicly held. Each of those will have a dramatic impact on their publication strategy and on their actual clinical trial transparency strategy. So you trying to suddenly go, "I'm going to match them," is problematic. The additional consideration that comes out of this is who are your competitors? Are your competitors people who are the large pharma players, like a Novartis or a Pfizer? Or are they more companies of your size, which may often be niche players. I've worked with clients of multiple sizes. I've worked with clients with rare disease states versus less rare disease, shall we say. And the implications are different. The types of goals you have are different. And that causes just wholesale copying of a competitor, not the best place. So that'd be number one, knowing what your competitors are doing, but understanding who your competitors actually are. Major: Okay. Darshan: Your second one is something I hinted at in this, which is understand what your end goal is. So what happens here is that you'll see a lot of companies going, "You know what? I want to have a clinical trial transparency strategy." That's great. That's smart. Here's the problem with that. If you don't know why you're doing it, you're going to have essentially a tail wagging the dog and you'll have to keep coming back and rechanging what you're doing. So we've had situations where clients will come in and say, "You know what? I want to have a global clinical trial strategy because we've made some commitments and we want to stick to those commitments." And that's important. We'll have some that say, "We are an extremely patient-centric organization, and we want to be forthcoming." We've had people talk about how patient advocate groups have called them out on it. We've had situations where they are members of a global consortium like pharma or bio. And the implications of that are you need to follow the rules set forth by those organizations and therefore they need to follow that. So each of those and many of those and additional pieces may all play a role in what your end goal is.