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Ruling: Clinical Trial Transparency

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Transparency, or the practice of disclosing clinical trial data, is highly important in clinical research. What happens when companies decide to not publish all of their clinical trial results, and fall out of compliance with the FDAA? FDA regulatory attorney Darshan Kulkarni discusses the dangers of not being transparent, and the consequences facing companies who withheld their results.

Darshan: This is breaking news and we should probably talk about this a little bit further. We've spoken before about the idea of transparency, especially in the context of clinical trials.

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

Darshan: What's really important to recognize is that transparency matters. And why does it matter? It matters because it's coming from the perspective of patient centricity. The first question to ask is, well, how has patient centricity connected to transparency? Transparency is one of the hallmarks of building trust. And if you're going to engage with patients, if patients believe that you're engaging with them in an honest, trustworthy way, they're going to expect transparency from you. Transparency actually holds companies responsible. It holds patients as true stakeholders in the process, so transparency matters.

Darshan: So, what is the current state of transparency globally? There are primarily three or four major buckets in terms of global transparency. The countries that really come into play for the most part are the, and I'm going to also call the countries or country blocks, so the EMA being a huge portion of it. There's Japan that has some portions of it. You've got the UK, which is connected to the EMA now, but with Brexit coming on it has slightly different requirements. You've got Canada, which is trying to follow the EMA in many ways but not quite. You've got India, which talks about transparency and anonymization and balancing those two requirements.

Darshan: Then all of this comes together in the context of six major buckets of information. The first being studied registration, the second being result reporting, the third being those reports that came out of your study. They need to be published and available in a way that's understandable to the scientific populous so that they can read them, evaluate if your results are accurate, CSR disclosures, clinical study report disclosure, which is actually going in one step further and saying, "Show me the CSR, take out the pieces that are confidential and let me see the rest of it." The actual data itself being disclosed so that people can actually play with the data, see what actually makes sense. And the last one, which is, we spoke about the scientific publication, but having lay versions of that, lay summaries if you will.

Darshan: We've spoken about what these six buckets are. What are the expectations in the US? There've been three major expectations in the US, the first being the fact that under, under specifically FDAAA, you're required to register your study and you're required to report the results and the CSR disclosure. There was a recent CSR disclosure pilot that started maybe 2018. I believe it was January, 2018, and the pilot itself was discontinued in 2019. Around June of 2019 the FDA came out and said, "Thank you, that was a great pilot. Feel free to comment on it. We're looking at some other options as well." And then the basically put our $10,000 per day penalty that could apply if the results weren't appropriately reported.

Darshan: But for the most part, the industry has seen to be a bit of a toothless tiger. Unfortunately that has not played well. It goes to the whole principle of, well if you're trying to be transparent, if you're trying to be forthcoming is the fact that you aren't disclosing everything that was required to be disclosed appropriate? The Yale Media Freedom Information Access, MFIA, and the New York University Technology Law and Policy Clinics on behalf of Charles [Sifey 00:04:07] and Dr. Peter Lurie, in coordination with the Yale Collaboration for Research Integrity and Transparency filed suit against the FDA, NIH and HHS. [Sifey 00:04:19] is an investigation journalist at NYU whose work focuses on science and technology. Lurie is a family physician and the President of the Center for Science in the Public Interest and a former Associate Commissioner of the FDA. In December, 2018, MFI filed suit and they sought to close a loophole and requested a declaration that NIH and HHS' interpretation of FDAAA was inconsistent with the statute. Essentially, the NIH and the HHS had taken the position that not all the studies needed to be disclosed. The case was heard in February 2020, and we got a result back in the last few days.

Darshan: Essentially, the law says that sponsors of clinical trials that investigate the safety and efficacy of medical products must publish the results, but they don't always publish their results where doctors and patients can find them. Instead, sponsors have effectively [chargeback 00:05:20] data by publishing favorable clinical trial results and kept secret the unfavorable results. Recognizing this problem, Congress enacted FDAAA to ensure a flow of clinical trial evidence to patients, clinicians, and researchers are using basically And for now basically required responsible parties, which are the sponsors, to submit to defendants to include on results for loophole trials. And therefore HHS, which said that not all the studies needed to be reported was taking a position that was different from what Congress had intended. Judge Naomi Buchwald in the Southern district of New York held that the FDA, NIH and HHS' positions misinterpreted the 2007 law and it required the government to collect and post about a decade's worth of trial results that should be published under the 2007 law. Essentially, we're talking about hundreds of clinical trial results being made available, so companies are going to have to go back through their own records and find the information that's required, going back at this point about 13 years, I guess 10 technically. But the impact of this is it'll help government agencies being held accountable along with private players like the industry.

Darshan: The court also held that it could not grant ... It wasn't a full win for Yale's team, if you will, and NYU's team in that bid actually also asked that NIH post public notices of noncompliance whenever a sponsors failed to submit results. NYU and Yale are considering appealing that, but for now that's not happening.

Darshan: Then there was essentially how are you going to go back and become compliance? So, what does this mean for you as a pharmaceutical company? What this means is you need to go back, you need to find your studies, you need to report them because not only are there patient advocacy teams that are coming after you, but now courts themselves have gotten involved and HHS and NIH will comply as well. So stay tuned, listen, and see where this takes us. But it's going to be interesting.

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

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