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.
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. And without having that context... Or you may simply go, "I just want to meet regulatory requirements." And that is another end goal and that becomes another consideration as you set up your clinical trial transparency strategy. So that's number two, your first one was know what your competitors are. Second one is know what your end goal is.
Which really takes us then to the third one, which is where are you trying to be compliant? So often as part of setting up a global clinical trial transparency strategy, you need to understand what parts of the globe you're trying to adhere to. So the transparency requirements around say, Thailand may be very different from the transparency requirements in the US which are very different from the transparency requirements in Ukraine to then different in Greece. Which ones are you trying to follow? Which ones matter to you? And that's something you need to have a clear understanding of because without that... There's no such thing as a global standard. Each of these countries will have different ideas and considerations. So that's number three.
Major: So, just to recap, number one, know what your competitors are doing. Number two, know your end goal, make sure that you have that defined. And number three, know what your must-haves are. Like you said, transparency requirements are different in different parts of the world, right? So what happens in Thailand is different from what's in the US and maybe definitely what's different, the difference in... I can't even talk right now, man. It's different than what's in the EU.
Darshan: Correct. Exactly right.
Major: What's number four?
Darshan: Well, number four, I would start thinking about is what is your timeline? So you've got companies that are coming online now, and they're basically saying we want to be the vanguard of clinical trial transparency. And we go, "Okay, what does that mean to you?" "Well, we want to be extensive and we want to disclose everything." "Okay. That's really good. Why?" "Well, because that's important to us." Great. Those are all good things. Here's the question. Can you tackle all those issues at the same time? And often the answer is no. You've got to have a timeline. You've got to have considerations. You've got to know which countries to start from. So you need to have a timeline. You need to have a short-term timeline, a medium-term timeline and a long-term timeline. And-
Major: Why do you have short, medium, and long-term though? I mean, so they say we have these goals that are important to us that may not actually help us achieve the end goal ultimately, but why would you have different timelines for each of those?
Darshan: So a really good reason for that is because you may actually be legally incompliant, or noncompliant. Think of it this way. You might be in a situation where you will be expected to have all your ducks in a row because the FDA requires that you post your clinical trial results appropriately, and there's a $10,000 per day fine if you don't. That's one consideration. However, you might take it to the next level and say, "I need to be in Europe." Or you may say that, "You know what, I need to be able to publish my journals and those need to come out." Obviously the $10,000 per day penalty will have much greater implications than I need to publish my journal. However, it's something to consider as part of your plan. And that's where you start from. That's where you consider where to go from there. So once you develop your short-term strategy, you might say, "Okay, I want to look at patient advocacy organizations and what their considerations are." That might be a medium-term plan. And then your long-term plan might be, what does a long-term transparency structure look like? Are we going to incorporate that into a patient-centric organization? And what does that mean for us? So that evolving nature might be part of your long-term. That's just an example. There are many, many ways to set that out.
Major: Okay. So you essentially have different milestones for the timeline, and then you can group those timelines into maybe short, medium, and long-term based on the needs and the requirements?
Darshan: Exactly right. Thank you. And that's why we have Major here, guys. Because he explains what I'm trying to say in a much more succinct way than I ever could. The fourth reason is when you're preparing a clinical trial transparency strategy, it's important to recognize what other systems are being impacted. So people are often going, "Oh, I just want a transparency program. I'm going to set that up immediately. Here's a policy. Let's start growing." Here's the problem. You're often working on a privacy program and you're expected to keep your clinical trial patients or subjects confidential. So there might be an impact on your privacy program. There might be an impact on your compliance program. When you're developing your clinical trial informed consent form, have you gotten consent from patients to disclose their information? You might see implications on your corporate social responsibility platform in your program.
If you're going to engage with investors, what is the impact of a transparency strategy on what you're going to disclose to investors? Because let's remember, anything you do, if it's material enough, investors are going to look into it and they're going to delve into it and cross-check it against information that's out there. So that's going to change how you create a plan. So different considerations if you have a publication strategy, for example. You might be in a scenario where you're saying that publications won't publish what I have unless and until I get the data disclosed as required by what's called ICMJE requirements. So each of those will play an impact in how you develop a transparency strategy and a transparency plan. And that's number five, I believe. Isn't it?
Major: That was number five. So recapping six considerations in creating a clinical trial transparency strategy. What a mouthful of a title. Number one, know what your competitors are doing. Number two, define and know your end goal. Number three, know what your must-haves are. And number four, know your timeline. This is where you define where you have different milestones that can be grouped and then you adjust where they exist on the timeline, depending on internal and external requirements. Number five, know what other systems are impacted, publications, privacy, compliance, clinical informed consent, investor engagements, any sort of corporate social responsibilities. Those need to be understood and defined before you jump into this. And what's number six?
Darshan: So number six is actually more of a organizational structure problem you'll often see. So if you have a larger organization, it's often well-structured and you've got a situation where you've got to now create new links to enable transparency to happen. And that, itself, is difficult because people are now taking on new tasks that they didn't have before. Alternatively, if you are a smaller organization that's growing, which often is the case, then you've got to essentially create whole new paths because they may not even exist. So either way, whether you're talking about a top-down structure, whether you're looking at matrix type organizational structures, you may need multiple signatures, or you want to have one person in charge with direct sign-off responsibility, all of those need to be considered. So number six is having a clear organizational structure.
Major: Okay. That's actually pretty straight-forward, much more than the mouthful of a title that we've got going on. So do you have anything else to add?
Darshan: No, I would say that the one thing I'd want to add is if you have questions about what this means for your organization, feel free to reach out to us and Major will have some contact information downstairs. Or, well not downstairs.
Major: Downstairs in the description. Absolutely. So go to the post for this website or rather, go to the post for this episode on darshawntalks.com. Join our newsletter to obtain an infographic that will better represent this in a much more succinct form. But have a good day, guys.
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.