Clinical Trial Transparency: What’s Important In 2020

Darshan: Welcome to another episode of Darshan Talks. This one's really exciting, because I get to talk about something I'm really passionate about, this idea of patient centricity. And what I really think is interesting is, 2019, in many ways, has been the year of the patient. And the reason I don't like saying things like, "The year of the patient," is that implies that, well, it's done, we can move on now. And that's not really it. I guess a better way to phrase that would be, starting the year of the patient. People have been talking about it for decades at this point, but you could see some real solid measures starting to come into place, and I don't necessarily mean this at a conceptual level, but at a regulatory level. At a level of people actually taking steps. 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: For those of you who don't follow a patient centricity space as much, it's kind of interesting to think about patient centricity consisting of four major arms. There's the privacy arm, there is the transparency arm, there is the innovation arm, and then there's the access arm. And if you can get these four major arms together, you are really engaging in true blue patient centricity. Darshan: As we talk about patient centricity, it's important to recognize that, if you are a company that's taking steps in transparency, you need to look at these other three arms to understand how they all work together, otherwise what you really end up with is significant blind spots that may affect the other efforts you're making. Darshan: Let's talk about the innovation arm. What's happened in 2019 that may change things? More specifically, as drug prices have been soaring, patient advocates and lawmakers, et cetera, have pushed the federal government. And what they're saying is, they want the right to suspend a drug maker's patent and license someone else to produce the drug. Darshan: So an example of that is what's called the Bayh–Dole Act. And the question is, is this generally possible? Most IP experts disagree on exactly how applicable it is, and there are some shall we say, varying opinions on this. The Trump administration hopes to clarify this. But if I was a patient, I'm not sure killing innovation is necessarily the direction to want to go. Having said that, innovation at the price of access is not really what you want to do either. So those are two different pieces of the same pie. Darshan: We can then talk about privacy and what happened in 2019. Everyone knows that GDPR came into effect in 2018. Companies have been dealing with it, but the ramifications really came into effect... 2018 was more of an awareness process. People are like, "Oh, okay, I have to follow GDPR." Darshan: In 2019, companies are still dealing with, "What is GDPR and does it apply to me?" And it's primarily, and especially interesting, in the context of life sciences companies. I've heard rumors of CROs telling sponsor companies that they don't want to engage in clinical research in the European Union because it's simply unclear what people's requirements are. And even the US secretary of commerce says that GDPR creates serious and unclear legal obligations for both private and public sector entities, including the US government, and it's unclear what's required to comply. And this obviously has implications on medical research. And I'm paraphrasing what he said. Darshan: And obviously, what adds to this whole process is GDPR obviously is pretty onerous and the penalties are significant. However, because of exactly this, the different states and the different countries... The member states and different countries can take the own version, if you will, of GDPR,