Darshan: As you may know, we've done a previous conversation on what is clinical trial transparency, what big things happened in 2019 that changed the clinical transparency landscape? But what's important now is what does 2020 look like, and what are the implications of that?

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: Just sort of doing a quick recap, what is clinical trial transparency? Again, it really goes to a company level process of providing clinical trial data to providing clarity and an ensuring that patients and providers understand the types of studies that were being done. There are multiple levels, depending on which organization is looking at it. Ben Goldacre, through AllTrials, talks about knowledge that a trial has been conducted, brief summary of the trial's results, full details about the trial's methods and results, and individual patient data from the trial.

Darshan: The EMA actually goes forward and actually talks about ... Well, before we go to the EMA, we can talk about Bioethics International and Jen Miller, who talks about participant level clinical data being provided, the drug and data level measures, results reporting and publication being available, company level overall transparency requirements that were available, and feasibility of the measures and ranking tool to provide ... And that's basically to improve company data sharing policies. So that's the lesson multi-component measure that she uses, that Bioethics International uses.

Darshan: EMA takes a couple of steps forward. It actually goes out and says, "Not only do we want to see your data, not only do we want to know that your studies were actually being put out there, but we want to actually understand more. We want to actually make that data available and accessible to patients." So they actually talk about having a plain language summary requirement, they talk about CSR disclosures. And then neither one of these actually talk about it in the same way. Well, not going to say neither. None of these talk about this in the same way. However, there needs to be another disclosure around efforts to actually make data available. And I don't mean actual individual patient data, I mean information collected, the results available in scientific publications, and that has to be an effort to not bury data just because you don't like it.

Darshan: And that has had implications in Health Canada and Ukraine, and in terms of issues around how the US FDA is dealing with it. What common mistake I see is people looking at clinical trial transparency and seeing it in isolation. However, I think that you cannot see clinical trial transparency and not understand the GDPR or the privacy implications. Again, you've got Health Canada, which has its own version of privacy that they need you to look at. You've got GDPR in Europe. You've got, obviously, HIPAA in the US, and how do you manage all these expectations? And now, again, if you are paying close enough attention, you've got CCPA coming in in California and there are several other States that are looking at it.

Darshan: So let's talk about what the future looks like. So study and registration, both AllTrials, Bioethics International, they will continue to enforce at ... Well not say enforce. They will continue to oversee and promote the idea of transparency in this form. AllTrials tends to be a little bit more aggressive, shall we say. Bioethics International tends to work a little bit more to make sure the information comes out. The FDA will begin enforcement. I potentially see that happening in the near term, and then more British studies will be registered because there were, in 2019, there were these examples where very, very few, I think fewer than 18% of studies were actually being registered from academic medical centers.

Darshan: So that has already started changing, and I expect that to keep changing, and if not, improving. Well, I expect it to improve, if not becoming excellent. And there have been examples. I believe it was King Scholars that actually went from having less than 18% all the way up into the 90s, which is exceptional. That's excellent. Over like a six month period. Then those results, disclosure again, we expect to see Bioethics international and AllTrials hold pharma, hold medical device companies, expect them to be as informative as possible and be as transparent as possible. And again, we're going to see these British studies come out more.

Darshan: I'm surprised that it's only limited to Britain so far. There was an actual article that came out in Britain that makes British studies a little bit more interesting. However, I expect more companies in Europe to go, "You know what, I'm doing ... More academic institutions in Europe to go, "You know what, they're doing this in Britain." As the EMA sort of feels more comfortable in Amsterdam as they, as they finish their move, I expect that the EMA is going to start looking at academic institutions and saying, "Why can't you be more like what the UK is doing?"

Darshan: In terms of [inaudible 00:05:18] publication, the [Amwar 00:05:20] standards will continue to be enforced, but they have limited policing power, so the impact on that will be limited. So companies that are forward looking, forward thinking, they will take the efforts and they will actually adhere to making sure that [inaudible 00:05:33] publication happens appropriately. However, smaller companies will not make an effort in this space and that's going to be problematic as we continue because these companies are often fighting for survival, but they're not taking into consideration the efforts of the people who are helping with their survival, i.e. the patients.

Darshan: In the context of plain language, I feel like the US is actually not going to do anything to encourage the use of plain language summaries. However, I think they're actually going to land up taking ... There might be this lack of effort on the part of the US is actually going to land up hampering the use of plain language summaries because plain language summaries by definition are patient facing, and if they are patient facing, is that considered to be promotional? If it's considered to be promotional, what are the implication of sharing plain language summaries within the US? OPDP might be concerned about something like this, and without the clarity from OPDP, companies, I've worked with these companies, are saying, "We need to understand what the policies, what are the ramifications of sharing data, of sharing plain language summaries that are patient facing?" That will actually hamper progress as we continue.

Darshan: Patient groups will continue to make independent progress, and they have actually had a very positive impact on larger and mid-sized pharma companies. But again, I don't expect the US, actually, to be taking many steps in this direction, so you'll end up seeing a dichotomy of results where many countries are saying, "We want you to put out information," and the US saying, "We want patient centric information," but don't give it to the patients, which is silly.

Darshan: Then you're going to have data disclosure. Again, people keep thinking about data disclosure being a good thing, which is absolutely is. However, how does that play out when you are talking about Europe? When you're talking about Europe, the big thing you need to think about is GDPR and how do you balance the requirements of transparency with the needs of privacy? And this becomes especially important in the context of rare disease state patients and orphan disease state patients, and you should be aware of that, but it also becomes relevant in the context of individuals who don't fall into those categories.

Darshan: And again, for those people that are saying, "Well I'm not in Europe, that's a good thing," well you've got the US, and the US you've got CCPA, which is the California privacy law. And again, there are exceptions in that for healthcare data, but again, whether a pharma company falls into that is up for debate, depending on the use of that data. So be aware, be careful. And I expect companies to be looking back and updating their rules in 2020 to include these privacy concerns.

Darshan: And then CSR disclosure. As you may know, in 2018, there was a pilot for CSR disclosures. The US actually put out a update to that pilot in 2019, and they said that, "We will put out a rule for further consideration. We just want your opinion, but right now, that pilot is closed," which again does not seem very patient centric to me. Ukraine will actually land up providing more details and they will actually provide more information on what they're expecting. So again, I think 2020 is going to be a very busy year in terms of understanding what the expectations are, and stay tuned for those as well.

Darshan: So looking back again, the main six areas being studied registration, studied results disclosure, scientific publication, plain language summaries, data disclosure and CSR disclosure. So each of those will land up having some movement forward. To know what that means for you, feel free to chat to me. I'd be happy to talk to you further about it. Or you can reach out to me on twitter @darshantalks or at our website at darshantalks.com. I look forward to hearing from you. Take care.

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.

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