CTSI Annual Pilot Awards to Improve the Conduct of Research

An Open Proposal Opportunity

Extending Direct-to-Participant Recruitment on the Internet with Effective Online Self-Screening Eligibility Surveys

Proposal Status: 

Rationale: Developing efficient and effective methods to recruit and screen participants for clinical research remains a major challenge for clinical discovery.

Traditional recruitment methods often involve building up large multi-site research networks and implementing cumbersome and resource-intensive screening processes that incur high fixed startup costs and delay timetables. These challenges hinder the scale and scope of otherwise worthy research questions and delay the production and application of clinical evidence to guide pressing clinical practice and policy questions.

Newer approaches have been developed to harness the broad reach, focused geographic targeting, and powerful economies of scale and efficiencies that are possible using direct-to-participant Internet recruitment. For example, we have recently implemented two studies, the WebTIA Project (completed) and a recruitment site for a stem cell trial for stroke (http://stemcellstudy.ucsf.edu, ongoing), and the CTSI’s Participant Recruitment Service has been working on delivering similar methods as a core service to accelerate the conduct of clinical research.

However, current Internet-based direct-to-participant methods have often been focused on the first step of identifying and targeting potential participants and matching them to potential studies, but less on how to effectively manage the volume of inquiries that these Internet-based efforts can generate.

For our most recent study recruitment website, we used an extensive online prescreening and eligibility process with participant-facing questionnaires to guide potential participants to self-report key eligibility-related questions. An automated algorithm then classified responses as concordant, discordant, or neutral for study eligibility in a way that accounted for differences in health literacy and for uncertainty in certain types of self-reported health information. This system allowed us to extend the capacity of research coordinators by prioritizing and focusing enrollment efforts on those individuals that may be most likely to meet final eligibility criteria and in ways that could be designed to prepopulate a study’s enrollment database after verification.

We believe that extending the Internet-based recruitment core currently under development through the CTSI Participant Recruitment Service with a robust and scalable pre-screening process would enhance the usefulness and potential for this recruitment method and would be the next key step toward the goal integrating pre-screening and enrollment activities with post-enrollment online clinical research tools.


We propose to extend the Participant Recruitment Service’s Internet-based recruitment core by adding a self-reported pre-screening platform for a pilot study that provides:

1)    The ability to classify pre-screening responses as concordant, discordant, or neutral for study eligibility in a way that accounts for differences in health literacy and for uncertainty in self-reported health information.

2)    Dynamic online reports and readouts for study coordinators to help prioritize potential for eligibility validation and enrollment.

3)    Integration with post-enrollment research system to allowed for moving validated data elements to a study database.

Criteria and Metrics for Success:

Pilot Website Launch

# website hits

# primary prescreening forms initiated/completed

# who pass primary prescreening

# secondary prescreening forms initiated/completes

# enrolled from this source

% of overall recruitment goal

% prescreened/secondary screened/enrolled meeting diversity criteria

cost per enrollee

Total Budget: $33,810

$33,810 (12 months) - 5% FTE for PI; 7.5% FTE of the PRS Technical Recruitment Specialist; 5% FTE of the Marketing and Outreach Coordinator; Website Design and Programming


Anthony Kim, Neurology

Nariman Nasser, Director CTSI Participant Recruitment Service


Focusing on developing an expertise around Internet recruitment is interesting. Key for this proposal will be to focus in on how it complements and extends the current suite of services and tools being developed by the UCSF Participant Recruitment Service (PRS) Nariman Nasser is the director of that program.

Yes, I just met with her this morning and we are working on ways to collaborate moving forward.

Another interesting example is: https://foxtrialfinder.michaeljfox.org/

Have you completed research to determine whether specific populations (i.e. minorities or elderly participants) are completing the online eligibility form at the same frequency as other populations? Alos, here's another site that was developed to match breast cancer patients with trials: www.breastcancertrials.org You might consider having a link on the eligibility page that would allow participants to search for similar studies if they do not think they are eligible for a given study.

Yes, concerns about disparities and barriers to access are certainly relevant here-- e.g. there is data suggesting that elderly Latina women are least likely to use the Internet for health information and there are other data that suggest that the so-called digital divide may be narrowing somewhat. Anecdotally, in our prior study of stroke and TIA, the average age of participants was 59 years old (range 23-88). In any case, thank you for providing the link and the suggestion. The clinical trials infrastructure in oncology seems comparatively well developed and the site provides an excellent example of what is possible in this area.

excellent idea. would be very helpful!

An interesting and worthwhile idea. The power of this would be to show that is generalizable to other studies. ie that other studies can define "an extensive online prescreening and eligibility process with participant-facing questionnaires to guide potential participants to self-report key eligibility-related questions" and that the automated algorithm can classify the results as you describe above. To show this, I would suggest focusing the metrics on demonstrating interest and applicability to at least one other research study.

This seems like an important issue and an innovative approach. I've done some work on trials recruitment for therapeutic trials in cancer, and in that realm the provider-patient relationship is key as providers tend to recruit their own patients. So the system is inefficient and clunky, but I'm not sure how else it could work. For that reason, this proposal would be even more compelling if you discussed what kinds of clinical research faces this problem of internet "over-interest" and demonstrate that websites are generating significant traction in recruitment. An earlier comment mentioned breastcancertrials.org Given the site's longevity, I assume it is generating traction but I'm curious to know more about which studies would benefit from this kind of approach.

Yes, the patterns of recruitment may be subject matter specific to a certain extent. For instance, we have had a large response to a Phase I/II clinical trial of a modified stem cell therapy for chronic stroke (stemcellstudy.ucsf.edu)-- a condition with a large pool or potential participants, few alternative therapies, and great (but as yet unrealized) interest in cell-based therapies by the lay-public. Many interested participants do not meet the narrow eligibility criteria and others are interested in cell-based clinical trials for other clinical indications. Here over three month, we have had 27,000 hits and over 500 have completed an extensive online eligibility questionnaire, and about 50 have screened preliminarily eligible.

Worthwhile idea and nice addition to our ongoing efforts to ramp up research participant recruitment services.

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