Transparency

Darshan Kulkarni: Hey everyone. Welcome to another talk about transparency. My name's Darshan Kulkarni, and I will be talking to you about some of the changes that we have in the context of transparency. If you want to hear more about what I do and what kind of topics that may come up and that I might be able to help you with, just go to darshantalks.com and you can hear more about what I get into. Darshan Kulkarni: What you want to look at is, when you look at global transparency in the context of clinical trials, you really want to start considering the type of information that is being requested. While there are numerous global authorities really talking about global transparency, you're really seeing the impetus coming from three major authorities of this moment, which is the US, so the USFDA, there's the EMA, and there's Health Canada. Just in January of 2019, there was a headline that, in the US, only 62% of clinical trials are being reported, and that the UK parliament was clamping down at universities because they were not disclosing the clinical trial results. So obviously this was hugely problematic. Darshan Kulkarni: The US obviously, as many of us know, really use something like clinicaltrials.gov to help look at clinical trial transparency. There are some exclusions. For example, phase one studies do not get included. It must relate to FDA regulated drugs and biologics. So for example, if you're doing a study for China that's never going to enter the US, you don't have to register that in clinicaltrials.gov, and then a controlled clinical investigations may, in certain cases, not be reported. Must be reported. Then there is medical devices and small feasibility studies are excluded. Prototype testing is excluded and FDA required pediatric post-market surveillance, however, is included. So to be included in clinicaltrials.gov, the trial must have one or more sites in the US, the trial's conducted under an FDA investigational new drug application or investigational device exemption, and the trial involves a drug, biological, or other other device product that is manufactured in the US or it's territories and is exported for research. Darshan Kulkarni: So in general, for a applicable clinical trial to be subject to the results, the requirements must be submitted by the responsible party no later than 12 months after the primary completion date. There are specific rules for studies that were terminated. Then Commissioner Scott Gottlieb, then FDA Commissioner Scott Gottlieb, in January, 2018, basically said that the FDA is taking on transparency measures to look to support the innovation and scientific inquiry related to drugs. Now that has gotten a little sidelined in recent times, not only because of COVID, but because of the FDA's own perspectives on what transparency should look like. In 2018, Commissioner Gottlieb came out and said, "Today, we're launching a new pilot program to evaluate whether disclosing certain information included within CSRs, which is clinical study reports, following approval of an NDA improves public access to drug approval information. In this pilot, we will select up to nine recently approved NDAs, who sponsors volunteered to participate and post portions of clinical trial related summaries from pivotal trials that were submitted to the FDA by the drug sponsor on drugs at FDA." Darshan Kulkarni: Since then no additional CSRs were posted and professionals, including Peter Doshi, Jennifer Miller, and Matthew Herder, came out on January 23rd, 2019, and said no additional CSRs were posted. So there was this disappointment in the community. Darshan Kulkarni: Then you also have to look at the Civil Monetary Penalties Act. In October, 2018, the FDA put out a guidance basically saying that i...