 Next, basically data dissemination related topic. So this is Caitlyn, oh boy, here we go, Mcheski and Jesse Reynolds will be speaking about their clinical trials dashboard out of Yale. Don't panic if the first, I think it's about 15 seconds of this, are really quiet. Also don't turn up your headphones a lot. After just a few seconds, the volume just back up to where I was expecting it to be. So welcome, and hey, our med folk. Can you push the button? I cast houses, the clinical trials.gov team at Yale University, which is the centralized office for clinical trials.gov for the university or for the institution. I created the clinical trials dashboard with shiny to help our office track registration and results. The food and drug administration amendments act or FEDA in 2007 is a law that requires certain clinical trials report results. It came into force for all trials that were due after January 2018 under the final rule. Since 2021, the FDA and the NIH have increased citations and notifications for institutions and not with non-compliance for required results reporting on clinical trials.gov. Many studies still do not submit results to clinical trials.gov. Some do not publish results after three years following study completion. Institutions are limited by a system which provides useful data, but additional steps are required to effectively track and monitor ongoing activity or plan for future actions. The data that administrators can download from the protocol registration and results system or PRS is not simple to utilize for tracking. Some institutions develop their own programs and procedures that may not be reproducible elsewhere. The FEDA trials tracker summarized compliance with mandated reporting to motivate academic institutions and other companies to improve compliance. Private companies like Trial Assure have developed software to monitor compliance, but this comes with a cost. To date, there are a lack of low-cost solutions to help institutions remain compliant. The clinical trials dashboard aims to increase compliance by making tracking registration and results simple, transparent, and reproducible. And a demo version of the app can be found by following the QR code. So the dashboard was created because the PRS provides information, but it can be overwhelming as we stated earlier. And answering simple questions like how do I determine the activity in my institution's PRS, or how do I plan for and communicate with study teams about future required actions, or where can I get all the information needed to do administrative tasks like mail merges, or how can I determine how many NIH studies are in the system? For example, when will results be due? So the dashboard can answer those questions. And some of the things that it does is it provides a prospective three-month dataset download. And what you can do with this is you can find studies that have required annual updates that are due. You can find studies that are due for results, whether it be for their primary results reporting or all study results reporting. And in this prospective download, you can also find which ones are applicable clinical trials or ACTs and which ones are NIH-defined clinical trials. The data elements in this prospective dataset can be used for mail merges, and it has all the required fields that are needed in the download. The dataset of review actions allows us to capture all CTGov team record approvals at our institution. It allows us to determine how many studies were registered in a time period by looking at the initial release date, and it also allows us to determine how many study results were submitted through the initial results release date. We can track the successful submission of records. So for example, with registrations, we can see how many were accepted and made public with two or fewer tries, which is called the first try. Graphic displays that are included in the report will have line graphs that show trends of various metrics. For example, with registration, you can see what's the average number of days to register a study, what's the average number of submissions before a study is approved, what percent of records were submitted and accepted on the first try within two tries, and what are the average days to publish this publicly from on the CTGov side. The dashboard can also be used to track successful submission of records with respect to results, and this would be the same accepted and made public with two or fewer tries or as we call it, first try. The graphic displays that can be included in reports with metrics of line graphs for results that will tell you what is the average number of days to publish results publicly, what's the average number of submissions before the results record is approved by clinicaltrials.gov, what's the percent success on first try, so out of all the ones that you submit, what percentage are successful on the first try, and what's the average amount of days to publish your results on clinicaltrials.gov. So in addition to doing those things, although these graphic displays can be customized. So for example, the graphic displays can be customized into subgroups and you can select different options. For example, study type or study phase, the intervention type, whether or not it's an applicable clinical where you're looking at applicable clinical trials or whether or not you're looking at NIH defined clinical trials. All of the toggles that are available can be used in different combinations. So for example, you can look at only NIH interventional studies with behavioral interventions. And in addition to being able to create subgroups in different combinations, you can also display your data in a custom date range. You could look at over a one-year period or a five-year period, and within that you can break these down into monthly or quarterly or semi-annually, so one or three or six-month timeframes. Okay, wait, let me go back to that. And then I'll just say, and now for a demo. And now I will go through a demo of the interactive dashboard. I will now go through a brief demonstration of the clinical trials reporting dashboard. On the landing page, the user uploads the record information CSV file and the review history CSV file, which can be downloaded from the clinicaltrials.gov PRS system. The tour goes through the different widgets available. This includes the date range of data to display, the date aggregation, and different filters for the data. The downloadable reports include a PDF report, including the tabular view of the registration and results plots, and information about prospective results or updates in the next three months. This can also download a CSV version of the prospective dataset, which includes information about the central contact and record owner, which can be used to create a mail merge. The plots included for registration include average number of days to publish registration, average numbers of tries to publish the registration, percent success within two tries, and averageclinicaltrials.gov response time. These are also available in tabular view. There are similar plots available for results, including average numbers of days to publish results, average numbers of tries to publish results, percent success within two tries, averageclinicaltrials.gov response time, and number of results published within 12 months from the end of study and days published past the primary completion date. The plots can be interacted with, including hovering over the data points for more information, and the plots automatically update if a user changes the date range of the data to display, or the date aggregation, or other filters, which are available. This is an example of the downloadable report, which shows the tabular view of the registration report and results report, and a prospective report, including expected updates and results in the next quarter. This also has a flag for NIH-defined clinical trials. This is what the CSV version looks like, which can be used to create mail merges to email those people who need to be alerted that updates are due. Thank you very much for attending our lightning talk about theclinicaltrials.gov reporting dashboard, and please reach out if you have any questions. Outstanding. I think we have time for a couple of questions. If people would like to throw them into the chat, I know there's been things going back and forth. Is there anything left? Or with both of the speakers here, is there anything else you'd like to add in in two minutes or less? I'm just curious about their experience with how difficult it is. Even well-meaning investigators often have trouble meeting their requirements. Do they see multiple tries and failures? So hi, Jesse Reynolds. So in my capacity, what I've found is that, yeah, people do struggle with trying to maintain compliance, but Yale has had a centralized office for this for more than 10 years. And so we have all sorts of levels of support for researchers, whether it be determining whether or not the study has to be registered at the IRB level to the supportive process of maintaining the record throughout the study, as well as, like myself, I'm a biostatistician. I'm tasked with helping people analyze the results, enter the results. The analysis for results actually is more for terminated studies, studies that don't meet their endpoints. But yeah, so we provide support for all of that, but yes, we find that people struggle. It's also a system that's difficult to use because people only go into it maybe once or twice a year. So one of the reasons why we created the dashboard was to be able to understand the institution activity as a whole, to be able to report back to our superiors, and to also be able to reach out to people individually and say, hey, you have this do or hey, you have this error or anything like that. Absolutely. It's impressive how challenging it is for relatively smart people who really want to comply, to comply. Yeah, no, we hear that all the time. And with the NIH now increasing requirements now, and now with data sharing plans, data management plans, and then also sort of all the other things that are sort of attached, the VA requires registration, PCORI requires registration, all of these federal entities are requiring all these things outside of what the FDA was already requiring. And then if you want to publish, you have to register your study. So it's, yeah, there's a lot there and we're working on it all the time. It's an amazing tool. I've already emailed the link to several people at Michigan. Thank you.