ClinicalTrials.gov Modernization Update
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On Thursday, February 18, 2021, Dr. Rebecca Williams, Acting Director of ClinicalTrials.gov provided an update on the progress of the ClinicalTrials.gov modernization effort and opportunity on how to volunteer to provide user feedback.
View presentation slides (.pdf).
TranscriptGood afternoon. I’m Anna Fine, the Assistant Director of ClinicalTrials.gov, I will serve as one of your moderators for today. This webinar will be recorded, and all attendees will be muted throughout the presentation. The recording and slides will be available within a few weeks.
You will note that the chat feature is disabled. Please use the questions feature to submit your questions throughout the presentation. We will take your questions and address them as time permits at the end of Dr. Williams’ presentation.
I will turn it over to our main speaker, Acting Director of ClinicalTrials.gov, Dr. Rebecca Williams.
Hello everyone. It's great to be with you here today. And thank you, Anna, so much for the introduction.
It has been a while since we had a chance to provide a broad update on the ClinicalTrials.gov modernization effort. So today is really the perfect opportunity to catch you up on what we have been doing. As always, I just want to provide a few brief updates about the program at the beginning. The majority of the time will be dedicated to talking about modernization.
I want to take some time to reflect on the progress we made to date, which has really been with the effort of many of the people who are tuning in to today's webinar. And to provide insights into some of the aspects of modernization that you haven't really been able to see since the last time that we came together.
Ideally, you will get a better understanding of expectations for what's ahead with the modernization effort. We do plan to use some polling today to better get to know the audience that we have with us, so we would like to start out with what we would call a warm-up poll. We’re curious, what time zone are you joining from today? We identified eastern time, central time, mountain time, pacific time, as well as Greenwich meantime and central Europe time. We hope we have folks from Hawaii and Alaska joining us, you can also indicate “other”. We are interested in where folks are from, from around the world.
Most folks have answered so I will be closing the poll in just a few seconds.
Thanks, Kate. The majority of folks are joining from the eastern time zone. That's where I'm located so it's nice to be with you today. It looks like we have folks from all over, so thank you for joining us.
We will be coming back to polling, so hopefully that was easy to use and we will get on with the discussion.
In terms of program updates, we continue to have COVID-19 really serving front and center here at NIH, and of course, across the world. I want to continue to touch base on the ways that we are serving the efforts related to responding to the pandemic.
We have made nearly 5,000 study records available on ClinicalTrials.gov that are related to COVID-19. We also helped to make available other information, other studies listed on the WHO's portal to give broader access to that information.
We are also dedicated to ensuring we are getting information out as quickly as possible, really fulfilling our commitment to those who have taken the time to provide that information in a timely manner.
We have been processing new registration study records within two business days and we have been expediting the review of results information that's been submitted, that's been happening within one week. And I’m happy to confirm that we are continuing to meet those targets and goals.
We also made available some different ways to look at the COVID-related research. We have on ClinicalTrials.gov, through what we’re calling the beta views, you can look at information based on location, funder, and the types of information being evaluated. Because research institutions were facing many challenges at the beginning of the pandemic, we responded to as many of those questions as we could through this Top Questions document that continues to be available.
One thing that continues to be sort of the strength of the COVID response here at NIH, is it has really continued to reinforce the benefits of having a comprehensive registration and results system available. That reporting research in a timely and transparent way meets the public's needs, and ideally, in this context, can continue to increase trust in the clinical research enterprise. It's been a really great opportunity to reinforce all of the reasons that ClinicalTrials.gov exists and is serving its purpose.
These efforts have also been reinforced by our director, Dr. Collins, who recently issued a statement to make clear the importance of having rapid access to results information related to COVID-19 related research, and issued this statement strongly encouraging our research community to submitresults information to ClinicalTrials.gov as quickly as possible. He means ahead of regulatory and policy deadlines.
For those who may or may not be aware, the standard submission deadline is typically one year from after the trial completes. And clearly in the context of a pandemic, that one-year time line isn't quite as relevant in order to meet the needs of our community.
I will open up our next polling question. I'm curious as to whether folks in our audience today have used ClinicalTrials.gov to look for COVID-19-related information.
>> And that poll is open. A couple more seconds.
>> Great, thank you. I hope this is an easy one to respond to.
Looks like we have about half and half. About half of our audience has used the site to find COVID-related information and the other half hasn't. And other folks, simply can't remember.
Then finally, I just wanted to remind the audience that when we do have new information and resources available for the community, we do post these. We do make these known through the “what's new” page on the ClinicalTrials.gov website.
And here I’m just highlighting some of the resources that are really more targeted at our data provider community. We have been adding study design examples we are hoping will better meet the needs of the research science community, as they are more commonly reporting information to ClinicalTrials.gov.
This was a partnership with the NIH Office of Behavioral and Social Sciences Research, and we continue to provide updates related to the regulations and clarifying aspects to help people continue to meet their regulatory requirements.
And then, finally, we just shared some findings related to an analysis that we conducted that highlighted some of the challenges that other communities are facing, mostly basic science research, which you see referred to here as BESH, being able to register and report those studies using ClinicalTrials.gov.
If you are interested in those resources, you can use our "what's new" page to find out more information.
Now I would really like to focus on the main topic for today, which is the modernization effort. This effort is intended to help ensure that we can continue to support the future of ClinicalTrials.gov well beyond the present day. We know that it’s a trusted and valued resource, and we are committed to ensuring that we continue to maximize the value of this resource to the public. And so that’s been the centering call for all of our efforts going forward.
When we first introduced the effort, we indicated that we would be approaching it from the center of the clinical research enterprise, really thinking about how ClinicalTrials.gov fits into the entire clinical research life cycle.
To better contextualize how we would approach it, we decided the first year was going to focus on engagement, and making sure we were understanding the needs of our stakeholders and all the different aspects they face either using clinical trial information or needing to provide clinical trial information, and then all the years moving forward would shift toward modernization.
I'm happy to report we had the opportunity throughout this year to really fulfill the roles to meet during this first year of the effort. We focused heavily on enhancing our infrastructure.
We focused most heavily, however, on engaging our stakeholder community.
Then finally, we used all that information to support planning the roadmap. All of the items that you see here are essentially important, and I’ll go into more detail into each of these as we move through this presentation. When we shift to thinking about the road map, the most important thing to really understand is this is a multi-year effort.
We are planning for this to occur over the course of a total of five years. You sort of see the plus side there. The road map that we are creating is really set, to set us up for the future.
There will be many things we accomplish within the context of the immediate five-year timeline, and they should be setting us up to achieve things well into the future.
Another important thing to point out is that as we are moving forward in the modernization effort, we are also continuing to focus on maintaining and updating our existing site and resources. While we focus on modernization, we also must ensure that our current systems are meeting the needs of our users as we move along.
The most exciting thing about this road map is we are really presenting three core components to how we are approaching the effort. What you see at the bottom is the technical infrastructure component. And it's at the bottom to help illustrate this is the foundation for all of the efforts moving forward. We are working to further enhance our platform to really be able to improve the reliability and the sustainability, and to again, support our growth well into the future.
As you see again though, at the top, and it’s important that this comes first, is the second component related to stakeholder engagement. We recognize everything we are doing at ClinicalTrials.gov to improve the site and to improve the aspects of how it's working is all in service to our users. We can't do this without you.
We started our stakeholder engagement efforts casting a really broad net. We wanted to ensure that we heard from as many people as possible. And it was just over a year ago that we launched the request for information to retain broad input from the community. At the same time, we also worked to establish an approach for governance of the modernization effort, and we’ve been well supported by the Board of Regents Public Service Working Group, that is a group off of the oversight committee at the National Library of Medicine. This group has been further supporting our activities, and I intend to provide insights into each of these, and how they’re continuing to drive the modernization effort, going forward.
I will return to the third component of the modernization effort, which focuses on the product development, which is the ClinicalTrials.gov website and the submissions system.
As I mentioned, we had cast a really broad net in terms of trying to get input to help us drive our strategic planning for the modernization effort. We did this through the RFI. And we had posed three main topic areas that we are looking for input on.
The first is the website itself, ClinicalTrials.gov, which most of you may be familiar with, interacting with and how that website functionality and programming interface or the API is serving you.
The second aspect focused on the information submission data provider community and those that provide the data that we all rely on. I can't emphasize enough how important this second aspect is because all of the information made available through the website is coming directly from the sponsors and investigators who are conducting the research itself.
The website purpose and how it works and functions is really dependent on much of the data that we receive and how useful that can also be to the community.
Then finally, data standards. This is really a cross-cutting area, and we were interested in hearing about how data standards may be able to better support submission management or the use of informational content.
One thing we also tried to make clear through the initial announcement of the RFI is that this really wasn’t focused on modifying any of the existing legal and policy requirements. Those requirements have really given us a fabulous foundation which we can innovate from. We are really focused on how the information we currently have is best serving the community.
I would like to pause here and introduce another poll to understand our audience a little bit further and reflect back on those RFI topics to understand what your primary uses of ClinicalTrials.gov are.
What we’ve identified here is whether you primarily search the information using the ClinicalTrials.gov website, that would include any usage through the API. Whether you are primarily a user of the PRS, meaning either you submit clinical trial information, or you support others in managing that clinical trial information. Then we expect some of you do both, so there's an option for that. If none apply, go ahead and indicate that as well.
Part of the reason we are asking questions and collecting information is to help us better understand our own outreach and engagement efforts and where we may need to, in the future, better target these efforts. So please respond, it will help us in our outreach going forward.
It looks like we have a pretty even distribution between those that primarily use the website, those that primarily submit information through the PRS, and those that do both. We’ll call those our “super users”. And it's really great to have such a balanced group here.
One of the nice things we have really enjoyed through the modernization effort has been the opportunity to bring together groups that aren't often in the same room together when working on some of these issues. It's easy to focus on one audience over the other.
From the RFI we gained some extremely valuable insight. I know some of you may have seen his information when we shared it last April, andthere’s a reason I’m coming back to it. The reason is the RFI responses are continuing to serve as our foundation and driving the things that we're going to be focusing on as we continue to work on the modernization aspect of ClinicalTrials.gov, in the context of continuing to balance the regulatory and policy framework that we are operating within.
What you see here is that the key themes really focused on being able to manage search results and study content. One of the significant things many people wanted was for the search features to be more user-friendly. But at the same time there's a desire to have more options to search.
Though these may seem like they are in competition, I think they really nicely overlap with each other. It's showing that the needs are pretty significant in terms of being able to better manage the tool, the information that people are using.
Secondarily, there's focus on the study record itself and how the content was formatted and how that was presented. There are limitations in terms of how much we can actually address related to content, but again, it became pretty clear where there are opportunities to look at where standardization or normalization of the content might make that first task of searching and using the information a lot easier.
And then finally, a theme that we heard across sort of all audiences whether it was a patient-type audience or a data provider type audience, is the need for plain language information. This is both general information about learning about clinical trials, as well as resources related to using the site features themselves.
On the data submission side, again, there were some very significant comments related to the information related to submission. In terms of the submission side of things, the data structure and format, was again, a recurring theme on the submission side. There’s really a lot of interest in how certain data elements were standardized but then there’s also a strong desire for more flexibility around some of these data elements and the record structure. And then again, the range of study designs, helping to support our data providers and understanding how those study designs can be optimally submitted using the system.
When thinking about the submission process itself, there's a great desire to really look at opportunities for making that submission process more efficient and simpler, as well as streamlining the quality control review process. That's a process by which we have reviewers here at ClinicalTrials.gov taking a look at the content before it is posted on the site.
And then finally, work flow management. Overall, many organizations are balancing the management of many study records and have a need for more advanced features to be able to better support their work.
Then on the third theme of data standards we saw a very significant set of comments that focused on balancing both the need to have standards but continuing to retain flexibility. People highlighted specific standards, that they were most interested in understanding how they might be able to further support either data submission or the re-use of that information as well as continuing to reinforce the importance of the fair principles which focuses on ensuring data is findable, accessible, interoperable, and usable.
Finally, there's a lot of encouragement around enabling technologies, exploring approaches such as natural language processing and machine learning that might better improve data quality and reduce the reporting burden.
As I indicated, we did share these findings back at the meeting we had in April. I'm reviewing the information from the RFI because it's continuing to serve as the foundation for how we are moving forward and what we’re prioritizing in the efforts related to modernization.
The other key thing that I wanted to reflect on from that meeting is that it's also supported by the Board of Regents Working Group who has been contributing to this effort along the way and havebeen really helpful in continuing to validate the themes that we shared from the RFI as the foundation for the effort going forward.
The working group itself has been quite useful because it includes current members of NLM's Board of Regents as well as key policy people here within the NIH community. But then we have been able to include external members who are really familiar with our key user groups and what their challenges are in using ClinicalTrials.gov either as a user of the public site or as a user on the submission side.
When we involve the working group, we wanted this group to be focused on some of the most relevant topics related to ClinicalTrials.gov and really thinking about the future. And what are the themes that are most important to the success of the program as we continue to plan ahead. And so, we charge the working group with really focusing on these three core issues. Focusing really on the integrity of the site itself, maximizing the utility of the information we have, and providing extensive input into the ways we are engaging with the communities to make sure that we are understanding evolving needs as much as we can.
The group kicked off in September, well, they were first established September 2019 with their first kickoff at the end of December. They have been very active having seven meetings to date. We do report out on this group in the open session to the NLM Board of Regents and we also have been posting the meeting minutes associated with those report outs to our modernization web page. You can easily follow the work that they have been doing.
To support the charge we’ve put in front of the working group, we’ve been working with them on what we’ve called participatory design sessions that have really focused on this framework presented here that is focused on how we go about actually implementing change around the modernization effort. It's focused on the vision as well as the outcomes we intend to achieve.
Of course, there's always challenges you may find along the way, and we have been tackling each aspect of the framework one-by-one.
In September we focused on the vision and outcomes aspect.
At the last meeting in December, we have been focusing on the challenges aspect and how we might think about mitigating those as we’re moving forward.
We’ve had some fabulous discussions and two of the areas that I’m highlighting here really represent some of the things that are in front of us and that we do seek to further bring clarification to the community on as we move forward with the modernization effort.
One was that the group has recognized the importance of NLM’s role in what I’m calling a data aggregator. What's truly amazing about the site is thatthere are clinical trials being conducted at thousands of research institution throughout the country and around the world.
You can imagine all the different ways in which that data is collected and organized and managed within those institutions. But we have this real value in being able to bring together all of that information into once central place that follows a standard format that really does help to improve the way people can access that information. And so, it's not to be understated, the role of being able to serve the US and the world in this respect, by having this central source of information.
Other areas that we have been focusing on that we intend to further clarify and bring greater light to, is there are absolutely areas through the modernization effort that we will be able to directly meet through the ClinicalTrials.gov website and modernization effort.
There are other items and goals and outcomes that may be best served by other organizations. We are thinking about this as sort of indirectly serving. We want to ensure that our role as a central aggregator of information can help to further the goals of those that continue to use and rely on that information. So that's an area where you can expect to see more information, as we move forward, with those working group activities.
But through this entire effort, again, it's been widely recognized, the role of ClinicalTrials.gov and the importance of it, serving as this really central aspect of the entire clinical research ecosystem, no matter what perspective you’re bringing to it.
When we think about our strategic goals, one, we really want to ensure that the information that's being made available is current, complete, and reliable. And we aim to support data providers in the best way possible to meet these objectives.
Secondarily, anyone can easily find and use information about clinical trials. If we are making available this information, ideally it should be easy to find and use it.
And then finally, the third pillar is really making sure that the tools we are providing are supporting others in delivering the value and the intended benefits to the system and to the users we serve.
And that's been the other really important finding, both from the RFI as well as from the working group efforts.
In terms of who the modernization is intended to impact, over on the right, you see internal stakeholders. This is really speaking to the need to support our own business processes here at NLM. To make sure we can operate efficiently, and to be able to best support those responsible for different aspects of policy and oversight of the system itself.
But mostly what we are talking about and what we will focus your attention on are the external stakeholders. We identified and grouped these into three primary groups. We recognize this is sort of an oversimplification of the users of ClinicalTrials.gov, but it's a convenient way to be able to communicate and I think the most important thing to take from this is that they’re all weighted equally.
It's critical as we are moving forward through the modernization effort that we are equally serving these core communities of patients and advocates and data providers. As I mentioned again, the work that everyone else does with the information on the public site is so dependent on ensuring that data providers have processes to provide efficient and high-quality information. And then finally data researchers. This is a group that is particularly heterogenius. We group within this group journal editors, systematic reviewers, IRBs, and others that are using the data in other complex ways to understand things about clinical research ecosystem.
I would like to pause here a little bit. Again, to understand who has joined us today, and which user group you most closely identify with.
We’ve identified here patients and advocates, and we do group in healthcare providers with that group given some of the common interests. Data providers would include PRS, investigators, sponsors, and third party support services that help with submission, really, anyone who is connected to the conduct of that research and providing it to us. And then finally, data researchers and journal editors including these other groups like systematic reviewers and IRBs. If none of those describes you well, please let us know that as well.
A few more seconds before we close the poll.
Wow, so today we are absolutely overpowered by our data provider community. About 61% of the respondents are those responsible for submitting information to ClinicalTrials.gov, followed by about 20% in that data researcher or general editor category. And then finally patients and advocates behind that.
So that really says to me that the data provider community has a lot at stake with the modernization effort.
The other thing that's important to us is again, understanding how we can better target our outreach to make sure we are equally reaching these groups that are so essential to the modernization effort.
And so finally, that brings us into filling in the third component of our modernization road map, to be able to serve this middle component of improving the ClinicalTrials.gov website and submission system, it's really both serviced by the infrastructure component, and most importantly by the users who rely on that information.
Part of what we have been doing over the time that you have had some less visibility into, has been establishing the teams that are going to be supporting this development work moving forward. We first stood up the team that's focused on the ClinicalTrials.gov website. We started with that because we knew it would be valuable in informing the efforts related to the PRS to really understand what aspects of using information were most challenging for our users and where there were opportunities to think about that also on the submission side.
The public site also gives us the biggest opportunity to deliver something new and meaningful and useful to the community as soon as possible.
The PRS and the submission system is much more complicated. It’s the living system by which people are managing information. We have been really dedicated to ensuring the planning that goes along with that side of our development process – really accounting for the needs of that community while addressing the complexities of updating a system that’s in full operation to be able to serve that public website.
There are two other things I want to focus on with respect to this development component of this road map.
Probably the most exciting for people listening in is that we are aiming to launch a new test version of the website in the fall of this year. We intend to run that test version of the website in parallel to the current site because that gives us an opportunity to really test how well it's working and to continue to improve it until it seems it's good enough to fully take over as the new ClinicalTrials.gov website.
The other really important thing I wanted to focus on here was seeing those circular arrows. As I mentioned, we started with a really broad approach to stakeholder engagement and understanding the things that we needed to focus on to make sure this effort was going to meet your needs.
And now, as we shift more into the development and implementation phase, we are taking an approach that's more targeted and using user feedback in sort of a smaller scale but to better inform the prototypes that we are developing and making available. The team working on the public site has really made tremendous progress this year, so I want to give insights into how that user feedback process is working and to highlight some opportunities for the community to continue to be involved in that.
How are we using user feedback? We know that people with different backgrounds and experience levels use the site for a variety of reasons and we really want to ensure that as we are designing and developing, we are taking into account the needs of real users, such as yourself, to make sure we are fully understanding those needs.
Part of the work that we are doing, and the way we have been managing our teams, is they work in increments or what you might call sprints. In the context of these sprints is when we are seeking feedback on the development.
What that looks like here, the circle on the left represents a typical design cycle we consider. You see the different components in terms of first learning and discovering the needs, so that the design team can come up with a solution that is really responsive to those needs. The team develops prototypes, and then we ask users for their input on those prototypes which the team would refine, revise, and put into an actual operational version that could be further tested to see it's fulfilling the needs as expected.
The rectangle on the right-hand side represents how that work gets organized into those sprints which are typically happening in two-week intervals. As an example, for the last sprint the public site team was working on, they were relying on the work of 30 different user interviews in which they sketched different solutions for what a search results page might look like, created a new design in that prototype, and then we were able to immediately transform that into something that was more operational.
We are doing a lot of the work, using this approach and in this effort and we are really excited about the results that we have seen so far. When we conduct user feedback sessions, we have three key ways in which we are approaching that.
One is through this more general user interview approach.
There's also moderated usability testing, that's really where we get to assess the efficacy of the first prototypes and to really understand from the user how well, or how not well, that prototype is meeting their expectations and needs.
Then there's a third type where it's unmoderated, but we are able to track and understand what's happening during that session through the way that the person is navigating the site.
Potentially the most exciting thing I have to announce, in addition to being able to share the road map, is that we are seeking participation for these user feedback sessions. We have a link here that I have on the slide and I expect the team will probably reinforce that in the chat itself.
We are certainly interested in having people identify their interest in participating in these feedback sessions. It is incredibly valuable to ensure that we are hitting our targets related to the approach we are taking to the design of the website. We do expect to reach out to people over the course of this year, and it may take some time for us to reach out to you. We know we get a lot of interest when we announce these types of things and we also can't guarantee that everyone who signs up will be contacted. We certainly encourage people to, if you are able and interested.
I think the other important thing to reinforce here, if you don't sign up, is that you will still have many opportunities to provide input. As I reflected on, we do intend to launch a test version of the site, to obtain broader public input later this year. And as that site is stood up, and we gain more experience with it, that will be another opportunity to continue to try things out, have wider testing, and provide input into that process. You certainly will not be left behind if you don't sign up here today for that feedback.
We are very much looking forward to continuing to have you follow us on this journey. I recognize that this road map is relatively high level and one of the things as we continue to move forward through the modernization effort is as things become more focused and more specific, we will continue to provide updates as best we can.
So just to reflect back on a few of the key things, overall, the targets are that we are really aiming to deliver an improved user experience, and all of these are in support of advancing the goals of having a comprehensive registration and results reporting system. And that's really intended to benefit the three key audiences that we serve. Again, patients and advocates are data providers and those who are using the data to support different research purposes.
The RFI feedback as well as user feedback loops are going to continue to drive how we approach the effort and so hopefully the themes you’ve seen presented, as we move forward, will be more fully addressed with the solutions that we provide.
One challenging part of this is also aligned with infrastructure upgrades, so continuing to ensure that these things are working in tandem is no small effort. But the focus of infrastructure upgrades is to really be able to continue to drive the utilities and the tools that we can make available to people.
Finally, the approach we are taking will always allow adequate time for users to try test versions and new things before they would ever be fully implemented. That starts with the prototypes I talked about but again when we make things available.
As I mentioned with the public website, there will be plenty of opportunities to try and use that content before we decide it’s ready for prime time.
The PRS side of the process is much earlier in stages of implementation. As I mentioned, planning and development for that work is really a significant effort and we are doing a good amount of that to make sure we are approaching this in the most logical way possible. And again, we’ll continue to keep you informed as more information and details become available.
One of the things we’re interested in understanding is what frequency in terms of updates to modernization is most useful to you. For some it might be on a yearly basis or twice a year. Or you may desire more frequent updates.We are also trying to figure out if it's only when there is something new that impacts users that might be relevant to you.
So please go ahead and answer the poll and again, help us to understand what aspects and frequency of communication will best serve your needs.
Thanks for the responses. It seems like most of the responses are centered around when there is something new that impacts users, that’s certainly understandable. Followed by more frequently than just annually or bi-annually. This is really helpful. Thank you for participating in the polls for the session today.
Some of the ways we have been communicating has been through the NLM Director's blog, providing information when relevant, hoping to disseminate information through that source. We most recently had a blog post last week that I encourage you to check out. One of the core points there, again, was that we are interested in continuing to ensure that we are meeting your needs while also minimizing disruption to users, along the way.
We also have an e-bulletin which we call Hot off the PRS because it's mostly updates for our PRS users, and we certainly encourage you to sign up for that as we will be providing relevant information there relatively frequently, basically when there's anything new for data providers.
And with that, we are going to take a quick pause and look through some of the questions that have come in, and I will turn it over to Anna Fine to help with that.
>> Thank you, Dr. Williams. We have a few minutes to take some of the questions that have come through the questions mailbox. Again, if you have questions, please do type them in the questions box, as we will not get through all the questions, we are reviewing them and assessing additional communication needs, so they are helpful to hear. I will now read some of the questions for Dr. Williams to respond.
Dr. Williams, there were a number of questions regarding plain language from two types of audiences. From the perspective of, will it be mandatory, and what kind of information would be expected to be provided in plain language for a data provider, and also from the patient audience who wishes to see plain language, could you speak to that?
>> Yes, that's a great question. As many saw, we reflected on this desire and th need for plain language. And I think it kind of falls into three categories which you started to layout pretty well there.
One is the content that we, as the host of ClinicalTrials.gov, provide and make available to our users. As we are moving forward, we are trying to think about, and as we are making new content available, say on the new public site, how we can do that in a way that is definitely more plain language oriented to better support people using the site.
We also saw that again as a theme in needing our data providers, needing to understand some of the regulatory requirements in more plain language information, so we will be looking at opportunities in that space as well.
The second area you mentioned is data providers and the focus of the content they provide. Currently within the framework we have for providing information, there are two data fields that are required to be in plain language. That's the brief title, sort of the first thing you see that describes the study. And hopefully helps people to determine whether they might want to read more about it, as well as the brief summary which is a really brief narrative about the study itself.
I think that's another area because those are required to be in plain language, where there's opportunities for us to provide better guidance on how data providers can better meet that need.
The other thing that wasn't mentioned that has come out through the working group work as well as the RFI was also needing to help put information in context for people. If people are searching for information on a particular health condition, there might also be a need to have plain language content related to that particular health condition. We already do provide links to other trusted resources, such as MedlinePlus. So thinking about ways to better elevate content like that, in case people are needing more than the clinical trial information, but needing more background information about what they are looking for to begin with.
>> Thank you. Another question came in from the data provider perspective related to timing and changes, and what will be the impact of changes that will be implemented? Is there anything the data provider needs to do to prepare and anything to test?
>> Yes, so I think it’s clear that even from the audience attendance today, it's clear the data provider community might be the most nervous. Hopefully, I can reassure you, you only have reasons to be excited about what may be coming. And really, we understand the pressures that our data providers are under, especially in organizing and managing your own work within your own institution. And so, there will be plenty of advanced communication about how data providers will be impacted as we move forward. And as we said, there will be plenty of opportunities for input and testing before anything would move into a more of a full implementation mode.
For the data provider community, I also just request, stay engaged and sign up to help provide input throughout the process. And that will continue to really help and support us in our efforts moving forward.
>> Thank you. We have a few more minutes to take a couple more questions if you don’t mind.
>> I would be happy to.
>> Great, we appreciate your time. What would be ClinicalTrials.gov’s biggest priority for modernization and what is the highest priority for improvements?
>> Ooh, that's a good one. I wish I could easily say there's only one high priority. That would definitely make things a lot easier.
I think absolutely, you know, we are looking to ensure that we have an infrastructure in place that can support us well into the future, but that infrastructure is only going to be valuable if it's actually supporting the needs of our data providers and providing high quality information with an efficient process. And then similarly, that infrastructure is only going to be valuable if it's actually helping users of the public site to take advantage of,sort of newer technologies and what that may offer, and really being able to extract value from that information.
Those three things continue to be our highest priorities, having the infrastructure and supporting our users.
>> Great, another question relates, there’s a number that relates to data standards. Could you discuss what data standards you might use and facilitate for the future, and have you made any decisions or selected any standards yet?
>> With respect to data standards, I can't say anythingspecifically with respect to decisions that have been made. The funny thing about standards is probably the fact it's a plural and that there's always more than one standard for one particular area. I think one of the main things we have been trying to do as we're thinking about moving forward in this space is understanding the environments that people are working in.
What standards are they already using? And how might those be better mapped to the requirements within the system? And then also thinking on the back end side where are there opportunities to sort of formally normalize data that is submitted.
We continue to see this as an area that can only enhance and hopefully make more efficient some of the data submission processes, but it's also quite a challenging area and will definitely be a space to follow.
>> There were several questions that were very specific so I will give a highlight of this. If you could speak to leveraging your collaborations or working with partners. The few that were suggested were efforts to work with EMA, ICMJE, Bio pharma, Transcelerate, or even WHO.
>> Yes, I hope there's a lot of those in the question-and-answer box. I think that's the other thing that's become really clear through these efforts is the interdependencies throughout the entire system.
For those not familiar, EMA, the European Medicines Agency, has their own clinical trial portal for reporting results information. And there are organizations that must submit both to ClinicalTrials.gov and to that portal.
We certainly understand the pressures associated with having the same data needing to be submitted to more than one place. We do continue to foster those relationships and aim to seek compatibility where possible, but we really do continue to appreciate your input on those things and helping to highlight opportunities that we may be missing.
>>Could you clarify your patient engagement efforts, and priorities for this audience, and how are you keeping them at the center of your efforts?
>> Yes, I think that has been an important aspect of our work.
When we initiated the public site team and effort, we actually had that group first working on the patient and advocate experience to ensure that we were understanding the space as best as we could. I think as you saw today, even from the audience members, we are looking for opportunities to further enrich and advance engagement with patient communities. Please continue to provide those suggestions as well to us.
We have made sure through our working group efforts to have those communities well represented. They have been extremely helpful as we continue to work through those aspects.>> Thank you, Dr. Williams.
Thank you for addressing these questions, and thanks to our attendees for submitting your questions. We’ll continue to read through them and assess additional communications.
This webinar was recorded and it will be made available within a few weeks including the slides.
We appreciate your time and participation with us this afternoon.
This concludes today's webinar and have a wonderful evening, thank you
>> Thank you, everyone.
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Last Reviewed: March 5, 2021