Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. Today's talk is going to be really interesting. We're going to be talking about clinical trial transparency, so we talked about patient-centricity before. You'll probably soon her it. Clinical trial transparency is one part of that. So, again, companies that are trying to do clinical trial transparency really need to understand and recognize that don't let this tail wag the dog. It's one component of a much larger piece.

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.

Darshan: Let's go back. Let's start thinking a little bit about what happened in clinical trial transparency over 2019 and what does this actually mean? So, a good way to start looking at this is thinking about what the other patient advocacy organizations are looking at. Most recently, Jennifer Miller with Bioethics International put out her ranking list. Novo Nordisk was ranked as number one as well as Roche. They both put out 100% in our rank, the highest on their transparency scores. Novartis was pretty close at 99%. Mark, Bristol Myers, Pfizer all came out above 92%, and then it went from there.

Darshan: Gilead, Johnson and Johnson, AZ were above 80% all the way to Allergan, which was at 47%. There are groups like AllTrials with Ben Goldacre, which is problematic as well. Ben Goldacre has, shall we say, a more aggressive relationship against the industry. I don't know if that's fair. At least the way I've read his stuff, it seems to come across that way.

Darshan: But, again, their goal is appropriate, which is companies should put out the information in a timely way, in a way that's understandable to patients. It's really just a question of tone, which maybe that's not the part to quibble over. The next piece to look at is what happened in 2019. There was early on in the year this report that came out that most UK universities were abysmally bad in putting out their clinical research information. In response, places like King's College improved their reporting rate from 18% to 93% within only half a year.

Darshan: On the other hand, for example, the University of Nottingham was singled out by the parliamentary committee in 2018, and now they've posted results of over 95%. So, again, you're seeing significant, and this was from TranspariMED by the way, so you're seeing significant impact and significant changes in clinical trial transparency. But let's talk about clinical trial transparency. What does that actually mean? What are the implications of it? How is this playing out?

Darshan: When you start thinking about... I think there's six major components of clinical trial transparency. There's the clinical study results disclosure, there is the clinical... Well, the presence of the clinical studies number one, the results disclosures, number two, the CSRs are number three, disclosure of the CSRs themselves are a redacted version, if you will. Number four would be putting out that information and having a commitment to put out that information in a scientific form. Then there is the putting out the information in plain language, and then there is the sixth version, which is giving out the data itself at a patient level. Obviously we just discussed how... Sorry. How universities are already taking significant steps to put out the reporting information and put out their clinical trial information more readily.

Darshan: So, that's good. That's great. That's a good first step for both the reporting of the studies' existence and of the results themselves. But then we take the next step as it relates to CSR disclosures, Health Canada has put out some requirements and companies are starting to take note, and are putting out information as well. You already had some initial companies that have already done this. The FDA considered its own pilot program and in 2018 they said that Cedar will release portions of CSRs from the sponsors NDA along with the action package following approval.

Darshan: In July, 2019 the FDA provided additional feedback seeing that the recruitment phase of the pilot has concluded, and they're publishing a federal register notice and they're looking for feedback on this pilot. However, what they also did was they're saying that they're looking at another effort that's going to provide greater clarity on the FDA's application and decision making process.

Darshan: And the question is should they really be looking at these separately, or is there better way to put up this information to have new integrated review documents instead of just releasing the CSRs? While this was all happening, and by the way... I keeps using the word CSR. CSR stands for clinical study reports. While this is all happening, you had Health Canada, like I mentioned, that's putting this information out there, but Ukraine's come out and said that, "We're not going to just wait for you to put out this information for clinical level information. We actually want this data at the preclinical information level."

Darshan: Now this has own implications and one of the big problems is a lot of the Ukraine data is actually in Ukrainian, so it's really hard to read. So, that has its own implications and problems. So, people are still trying to get their hands around it. When I looked up the requirements, essentially what they're saying is that they're going to put up more information about it. We don't have that information yet, but stay tuned.

Darshan: The EMA, as you said... Well, not as you said, as I'm saying. Yeah, the EMA has put out some requirements around plain language summaries, essentially saying that, "You're putting out this information, that's great, but it needs to be understandable to patients themselves who are actually participating in these studies." So, companies are now taking active measures. I've been involved in some of these to make sure that the information is available, accessible, understandable, which is a huge step.

Darshan: Add onto this the fact that companies need to start taking active measures to actually make sure that if they do a study, the study is available and published not just on ct.gov, or one of those other sites, but actually in journal articles. And I recognize, for example, that journals aren't always going to publish what you want to publish, so you need to take other steps, things like PLOS to publish in those locations.

Darshan: And while you're doing all of these steps, what you need to start thinking about is, and we talked about data disclosure obviously, you need to start thinking about not just these six elements, but tie this into GDPR and how these disclosures are going to be happening, because a lot of people make the mistake of working in silos. We're the transparency group, that's the privacy group. Sure, that's true. However, to do transparency right, you need to understand what your company's position is on privacy in terms of do you tend to be more stringent than what's actually required, which is very typical, or do you do it in a different way?

Darshan: Do you just say that we don't take this information? Do you say that, for example, in rare disease states, we're going to handle things in one way versus in another way? And when you start looking at company disclosures, that's what they tend to do. They tend to not do a one size fits all. They try to, to the extent they can, but obviously privacy has significant implications. So, stay tuned. 2019 was a big year, but we don't know what 2020's going to bring. The EMA should be more settled and we'll probably have more to share about that. Take care.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcasts, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks, or the show's website at darshantalks.com.

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