Publicly Searchable Database of Recruiting Studies
1. Rationale
There are multiple sources for clinical trial listings at UCSF that are available to the general public via the web. These sources draw their information from the national ClinicalTrials.gov registration system that is required prior to recruitment into an interventional drug, biologic or device clinical trial. While this is a trusted source of clinical trials information there is significant opportunity for improvement with regard to how potential research participants locate, search, and receive accurate and information that will lead to informed interest and participation in research studies at UCSF. By limiting searches for UCSF clinical studies to clinical trials registered with ClinicalTrials.gov the major deficiencies include:
- Registration is only required for interventional drug, biologic or device clinical trials – representing a limited proportion of all UCSF clinical research studies
- Post-registration updates to recruitment status and contact information not required or enforced and are therefore often outdated
- Summaries presented to general public are not presented in lay terms as derived directly from registration form
We feel that by creating a UCSF-centric listing with the public’s interest in mind that we can not only provide a valuable service to our patients and potential research participants, but can facilitate increased interest and enrollment into UCSF clinical research studies.
2. Plan
We propose to incorporate a searchable database of recruiting studies at UCSF in a simple web-based format that is uniform and appropriately written for the general public while leveraging existing and planned participant recruitment resources. We will focus on the following approach in an effort to improve accessibility to information on recruiting clinical studies at UCSF:
- Create a basic website with educational information on clinical research participation and a current listing of all UCSF studies that are recruiting, with GoogleSiteSearch functionality
- Develop a structured template for describing clinical studies at UCSF in lay language and provide examples and best practices to researchers on how to describe their study
- Obtain monthly reports from iMedRis of studies approved for participant recruitment; provide investigators with the template and notification of listing opportunity
- Upon receipt of completed study description, provide editorial by medical writer for approval by investigator
- Post study to website for search by the general public, including contact information for study staff
- Provide monthly updates to website listings and contact information for study staff
3. Criteria and Metrics for Success
Metrics include number of studies engaged and posted to website (interventional clinical trial vs. non), number of searches per month, number of studies accurately reflective of currently enrolling studies at UCSF per iMedRis as compared to ClinicalTrials.gov listings at quarterly time points.
4. Approximate Cost and Justification
$44,000 for costs of web programming, search capabilities, 30%FTE medical writer and 10%FTE technical coordinator.
5. Collaborators
iMedRis administrators, ISU
Commenting is closed.
Comments
This is a great idea! The key
This is a great idea! The key to this is making the data easily discoverable and reusable.
Questions:
(In terms of data reusability, there are a variety of groups around campus using iMedRIS data, or who could benefit from it. I presume you've already talked to Fabrice. You may also check in with Oksana and the GHS team, who are enriching/correcting iMedRIS data to meet the needs of global health researchers, and I believe CFAR and the Cancer Center may be doing the same with either iMedRIS or ClinicalTrials.gov data. Paul Volberding was brainstorming about the idea of having a common system for multiple groups to enrich iMedRIS data, instead of everyone doing it by themselves in little non-interoperable silos. For example, a number of groups could conceptually work together to crowdsource MeSH-tagging all UCSF studies.)
Thanks for your thoughful
Thanks for your thoughful feedback Anirvan. This would initially apply to current studies but would be updated monthly to ansure accuracy. This funding would allow the project to run for one year. Standard ontologies should definately be used to the extent that they exist in the vernacular of the layperson seeking information on research studies.
Out intent is to marry this information on the web along with the UCSF Research Participant Registry. Leveraging current methods used to increase traffic to the Registry, the CTSI websites and the Medical Center would be optimal. I know that many other conversations within and extrernal to CTSI are happening around the capture and use of iMedRis data and would definately hope to work together on common needs so that we can move away from silos, which is a goal of this project as well.
Linking with iMedris data
Linking with iMedris data seems to be the key to collecting the most accurate data on actively recruiting studies at UCSF. I think this project would prove to be a great resource for the 'Creating Personalized Connection to Research Interests vis the Research Participant Registry' proposal- especially if the plan is to house this database of recruiting studies on the Regsitry website. Linking the study status data to investigator's UCSF Profiles pages will only help the visability and searchability, since Profiles is so well established on the web. Making the study summaries in laymen terms gives it a leg up on the clintrials.gov data pull
Nariman,This comment is on
Nariman,
This comment is on the first phase of your plan - creating a dedicated web resource to list all current clinical studies at UCSF, based on the iMedRIS information. Could Accelerate.ucsf.edu serve as the "home" for this ? It is an established website with a long history on the web. Being well known to search engines, it would have a certain advantage in Google search ranking (much better discoverability from the beginning), compared to a brand new website. Besides, this service seems to perfectly fit the purpose of the accelerate.ucsf.edu as point of access to CTSI services for researchers and community. Adding a section on the existing website would be more cost effective compared to creating a new (even basic) separate website.
Our plan was to house this
Our plan was to house this along with the UCSF Research Participant Registry, which will inlcude expanded educational information on research participation, and is a web resource dedicated entirely to the general public interested in joining research studies. However, you do raise an excellent point about the advantages of the accelerate website and I think it's worth exploring how we can better connect the two to increase accessibility. I will add the virtual home team to the list of collaborators.
"Post-registration updates to
"Post-registration updates to recruitment status and contact information not required or enforced and are therefore often outdated"
enforcement has started and can result in fines in up to $10,000 per day.
it seems like rather than devising a system competing with ClinicalTrials.gov, having one which can leverage and work with ClinicalTrials.gov would be synergistic rather than creating extra work for PIs of trials required to report to ClincialTrials.gov.
Thanks for the information
Thanks for the information Stuart I was not aware that clinicaltrials.gov is now fining investigators for not updating their recruitment status. Can you provide any information or links to the policy regarding ho wlong after last participant is enrolled until investigators must make the update? thank you.