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On October 7, 2021, Dr. Rebecca Williams, Acting Director of ClinicalTrials.gov provided an update on the progress of the ClinicalTrials.gov modernization effort and information on the anticipated launch of beta ClinicalTrials.gov.

View presentation slides (.pdf).

Transcript

I'm really happy to be here with you today to provide an update where we are at with the modernization effort. The last time we had a chance to check in was back in February. It seemed like a great time to provide updates on what you can expect. I have a few goals for today's session and mostly wanted to highlight for you some upcoming changes that we are expecting later this year.

I know many of you have been tracking this effort from the start. I want to reiterate that this effort is focused on ensuring that ClinicalTrials.gov can continue to deliver maximum value to you, our users, well into the future. We have been focusing the modernization effort on a few key principles that will allow us to take advantage of the existing legal, regulatory, and policy framework that already exists while doing so improving the user experience while also upgrading the technical infrastructure and the processes that underlie it to enhance the future sustainability of the program. With these three principles in mind it is important to reinforce that all of this is leveraging our existing framework and we are really aiming to ensure that we are delivering the value intended by that framework.

Over time we have been communicating about both our vision and our strategic goals for this project. The vision is focused on ensuring that we are allowing ClinicalTrials.gov to continue to serve as an essential, transparent, and trusted part of the research ecosystem. For the purpose of further advancing medical knowledge and improving human health. The strategic goals that we have identified are in service to this mission. Today I will be focusing on the first two strategic goals focused on 1, ensuring the information available is current, complete, and reliable and 2, that anyone can easily use and find information about clinical trials using ClinicalTrials.gov.

We have also been communicating about how important it is that we are serving the needs of our stake holders, we have been reinforcing the need to focus on all of our primary stakeholders which are highlighted here: patients, data submitters and data researchers. In supporting these stakeholders, you will see through each of the strategic goals how each of these will be supported. Along the way, we have also been extremely well supported by the national library of medicine board of regents working group. The vision and strategic goals as well as the impact on our stakeholders has been an important product of that working group. The working group has helped to keep us focused on some of the key goals that we want to accomplish with modernization and focusing on some key findings while we work on those goals.

What you see here is the cover of a report we made available on the board of regents working group web page. This report is intended to summarize progress made on the modernization effort to date, much of that progress has been focused on the user input and stakeholder feedback aspect as well as our strategic goals and some of the key findings of the working group. You see those highlighted here. The working group is essential in reinforcing the national library of medicine's role as central data aggregator. This is essential because it allows for one primary place where all of our stakeholders have access to common information. The working group has also been essential in reinforcing the need to serve all of our primary stakeholders while also helping us clarify what needs NLM is able to serve directly versus which ones are more indirectly served by modernization process. We are looking to better reinforce and manage the site's purpose, limitations, while helping to establish user expectations. I recommend taking a look at this report and there will be some highlights that will be presented today and further in additional webinars as more modernization information is released. The report on our work today is also focused on ensuring that we are collecting adequate feedback from our users to ensure everything that we are building is going to better support the people that rely on our systems.

If you have been following this project you are familiar with the RFI that we had initially released to gather input. Since that point in time we were able to take all the input from the RFI, and identify additional information needs we researched through conducting individual interviews with people from our primary stakeholder groups and transforming that input into a design that was initially tested with users throughout this process what is exciting is we have been funneling all this information, we are here today to preview the fact that there will soon be available for public testing, the products of all of this user research and design. What I will be sharing today is what you can expect in the upcoming months what we are calling beta releases for both public website and PRS to allow many more people to try out and give input into what is currently being developed.

The next section of this webinar is focused on how you as user will be able to review and explore upcoming changes to our system. I describe this generally for both systems the PRS and the ClinicalTrials.gov website. The general concept is that we will be releasing beta sites in parallel to the existing or current site. . This will allow us to be able to add additional features to the beta site for each of the systems to better meet user needs. Once each of the beta sites are complete, we will be shifting the beta site to be the primary site allowing the current site to be available for quite a period of time so people have adequate time to transition to the new sites we will talk in more detail about what this means for both the PRS and ClinicalTrials.gov websites and there are different implications in terms of the beta releases it is important that we have an opportunity to test the real world performance of the new technologies that we have been employing. Referring back to that initial slide that I showed, a major part of this effort is not only addressing user experience but also upgrading the underlying infrastructure that we rely on. This is an opportunity to introduce that in order to get experience with the real world performance.

You probably want to gain more of an understanding of how the new beta releases will contribute to your own user experience. For the PRS, we will be introducing new workflow features around functionality to manage study records which we will talk about in more detail. For the ClinicalTrials.gov website we are introducing some of the basic foundational features for the website that will create a more inclusive experience for all users and we will be continuing to gather user input. Each beta release is really a way to introduce the new sites and continue to build and improve on them over time. Shifting to protocol registration and results system or PRS, this system aligns really well with the first strategic goal which focuses on ensuring that clinical trial information is current complete, and reliable. The best way we can do that is to ensure that our data submitter community are as well supported as possible with the PRS submission experience in the PRS in order to achieve this goal. In the context of PRS we support over 200,000 different users in the system. We have a range of different types of users who maybe frequent or infrequent users with some having extensive organizational support, where some use a centralized processes to help manage the submission process while there are other types of organizations and users who have minimal support for example individual investigators who are interacting directly with the system.

When we are considering our user needs we need to take into account the full range of users and their needs when using the PRS. The best way we have been able to do that is from the stakeholder input we have received from our users. On the PRS side, there were three key themes we have been communicating about that have been important in the context of what users would like to see from an improved PRS. It focused on data structure and format, submission and quality control review process and work flow management. In terms of what the first beta release will cover we have decided to focus this first piece around work flow management. What we learned from users during our user research to guide the changes related to work flow management feels sometimes almost silly to document because they seem quite obvious once listed out. It is really important in terms of guiding the changes that you will be seeing when it comes to the beta releases.

In terms of PRS user needs there is a real desire to ensure the study record information is being kept up to date and in accordance with regulatory and policy expectations in order to do that our users need to easily identify and access study records that may need attention with regard to updating and ensuring that various time lines have been met. We also heard it is really important to minimize the number of steps that it takes to accomplish all of these tasks ideally that means interacting with a more streamlined and intuitive user interface ultimately all of these things align with PRS users wanting to save time in accomplishing their tasks. In terms of our first beta release, we focused on the very first page that influences the ability for users to be able to to accomplish those specific tasks.

What you see here is the PRS home page and what I hope you can also see though it's probably a bit blurry is intended to demonstrate a more modern intuitive design, it includes the ability to do more actions directly from the record list which is in line with the goal of wanting to save time by having more information available at the record list allowing people to take more actions directly from the record list introducing more customization to allow organizations to better identify the study records that they need to focus on in the work flow, and ensuring that information is available for download is able to be worked with outside the system as well. People have been interested in how they will actually access these changes within the PRS. The idea is that you will continue to log in to the PRS just as you normally have and you will be introduced to our current PRS user interface. You won't notice anything different except for a little button that will allow you to link to the new beta PRS user interface. You have the choice initially of using the current PRS user interface, or beta user interface. Both the current and the beta rely on the same data as in the current PRS. No matter which system you are using, you will always be accessing the most current data. We will be introducing new components to the beta user interface over time. And you will be able to try out these new options as they appear. Data available in the beta site will also be saved to the current site. No matter which system you choose, you will have access to the most current data available.

While our first introduction is focused on the home page and record list, you can expect that there are many other important components of the PRS that will be added over time. We will share specifics about each of these options well in advance of them being available for use. We have also heard from PRS users the important considerations to take into account with the launch of these new features. Part of this slide is to reassure users that we have heard them, that we completely understand how important having new features is, as well as the importance of not disrupting your current work-flows. We are aiming to improve your work-flows and give you better options without disruptions.

Another important question is how new features will be introduced. Our current processes are that we apply updates to our PRS test site first and then they are rolled out onto the production site. We will continue to follow that same process with the beta releases. The new beta options will be available in PRS test first and then rolled out to the production site-keeping in mind you will still have the choice from the production site of which version you want to use - either the current or beta site, and we certainly encourage you to try out beta. We definitely understand that organizations have a lot of processes and educational materials centered around different PRS systems. When planning any potential transitions from the current site to the beta site, we will communicate early and clearly about those expected time-lines to ensure you have adequate time to adapt to the new features.

I will shift to the ClinicalTrials.gov website, which is in support of our second strategic goal, where anyone can easily find and use information about clinical trials. We have a wide range of users who depend on the ClinicalTrials.gov website. Our most recent data indicates an almost even split between researchers and patients who are using the site. We have a lot of first-time users who have different needs from those who are on the site daily and interacting with the site relatively frequently. We are taking all of this into account with our efforts as well. From the RFI, we have shared this information before as a lot of the themes focused on the public website- how people interact with search, how they access information from the study record itself, and how all audiences really benefit from plain language information.

There has been a need across all of our user groups to better understand how to use and interact with the website. As you can imagine, putting together a complete website, there's a lot of things to take into account. When we try to organize the overall design goals based on our user research we focus on the six key areas, as you can see here, ensuring that first-time users coming to the site, have a good on boarding experience, we are focusing on how to manage the search experience as well as how users access and navigate study record content. We want to make sure that people can intuitively navigate across the site and the way we are organizing information, focusing on where we can provide easy-to-understand content when that is in our control, particularly background information that is available on the site. And eventually connecting people to useful and trustworthy content related to the research information itself. These are goals for the entire website design process.

What you see here is the initial draft of what you might expect to see with the beta release of our -- of the website. As with the PRS, we are focusing on having a modern look and feel to help people feel welcome as they enter the site, improving the way the site works on mobile devices, providing easy-to-understand information where available and again we have been focusing on the underlying infrastructure. There is a new cloud based platform supporting the website. What you will see in the first beta release are foundational features that will continue to be added to over time. You'll see a redesigned home page, a modified search experience, and a redesigned search results page with a different format for viewing search results as well as revisions to the filters that are available to refine those search results. The study records have been reorganized. All the content is the same but we are trying to improve the way that the information is organized for people that are evaluating the information for any single clinical trial. We are introducing some additional plain language information to provide background information about the site itself.

This is a foundational release where it will have many of the basic features that you will need to use the site but there will be many more things added over time to ensure the site itself becomes complete. The current public site will continue to be available throughout the entire process while we are developing and building out the data public site. With the beta public site, we will introduce foundational features later this year and we will be continuing to add new features over time until the site is complete. Eventually the beta site will transition into becoming the main site and the other site will be retired. This is happening over the time-line of the modernization effort, so we still have a couple of years until we are to the point of retirement.

In terms of next steps and what you can expect to see today, we wanted to give you a basic preview of what is to come and share where we are right now. We will have additional webinars when the beta releases are available to you to try out. This will be by the end of the year. We don't have a specific date yet as we go to our final testing. There is a few things that are in flux but we will communicate as soon as we have those dates available. Once the sites are launched, we will continue to conduct follow-up and feedback with all of our communities that are using the site. We will continue to revise and more importantly, continue to add new features.

To stay up to date on the process, we will make the recording and slides from today's presentation available. All information related to the modernization is available on our modernization web page. We also send out updates through hot off the PRS e-bulletin- there is a link that allows you to sign up for that. I realize this covers a lot of information that you don't yet have access to, we are really excited to be sharing that you will soon have access and more of an opportunity to interact with and get many of your questions answered. Anna, I expect we might also have questions coming in during the webinar which I think we have about a few minutes to address if you will.

Thank you, Dr. Williams. Before I read some of the questions from our participants I want to remind those joining that you can ask your questions using the zoom Q&A feature by typing questions there. If we don't get to all the questions, we will review them for additional communication needs and they are helpful to have. I will now read some of the questions that have come in for you to respond.

One of the first questions is: what impact will the modernization changes have on ClinicalTrials.gov reporting requirements?

Great question, and I know that's one that's been especially important to our data submitters. I would reinforce that the modernization effort is aimed at better leveraging and supporting users with existing reporting requirements. It does not change any of the existing underlying regulatory policy frame- works that exist.

Thank you. A related question: if we make updates to study records in the PRS beta site, will old records need to be updated or is it required?

The first beta release is really focused on the home page and record list. It does not yet involve study records. In terms of future updates to the beta site' it is really focused on improving the user experience and it doesn't change the existing requirements.

Thank you. This question came in related to the API: will it continue to be an important part of the platform and how will updates to the API be seen?

The API is a really essential part of the platform and is important because it supports users in different ways. It allows many of our patient focused organizations to be able to provide more customized resources for their communities which we absolutely want to continue to be able to support. It also supports other third-party users including researchers to more easily reuse content for their purposes. The current API will continue to be available, and we are not making any changes at this point in time to the API. We will be keep you informed of new API resources and tools that we do intend to make available as part of the modernization effort.

Thank you. One more question: if more plain language is used on the site, will it change the requirement for how registration records need to be written?

Another great question. Initially our plain language efforts have been focused on content that we as national library of medicine provides. However, I will say that there is a need for data submitters to evaluate and improve certain data fields to better meet plain language expectations. There are two data items in our regulation: the brief title and the brief summary, that are explicitly required to be in plain language. This is certainly an area that we will be exploring in terms of how to provide additional guidance to data submitters in improving this content.

Thank you, Dr. Williams. We are at time so thank you for your questions, we will continue to assess any we didn't get to. The webinar was recorded and a recording and slides will be available in a few weeks.

There is a question that also asked how will you be notified of upcoming webinars: we will continue to promote them on our website, communicate through our channels, and -- ensure that notifications are escalated through various organizations as well. We appreciate your time and participation this afternoon