Clinical Trial Patient Recruitment for a Schizophrenia Trial

Overview

As a patient recruitment partner, ClinicalConnection was tasked with assisting in the recruitment process for a Schizophrenia clinical trial across 70 sites over a span of 22 months. The trial aimed to evaluate the efficacy and safety of a Schizophrenia drug in treating schizophrenia, a chronic mental health disorder. Our role at ClinicalConnection was to drive awareness, engage potential participants, and support enrollment through targeted outreach strategies.

Trial Objective

The primary objective of this trial was to recruit participants diagnosed with schizophrenia for a multi-site study assessing the effects of the drug, a novel treatment being investigated for its therapeutic potential in managing schizophrenia symptoms. Recruiting suitable participants was a challenge due to the stringent inclusion and exclusion criteria typical of psychiatric trials. ClinicalConnection’s task was to employ innovative and efficient recruitment strategies to meet the trial's enrollment goals.

Recruitment Metrics & Strategy

Throughout the trial, ClinicalConnection tracked and reported on several key recruitment metrics. These metrics help us understand the effectiveness of the recruitment campaigns and optimize strategies to enhance patient enrollment. Below are the key recruitment figures from the study:

Total Members Reached: The number of emails sent out to alert our database members of this trial.
Listing Clicks: The amount of database members and potential participants that clicked onto the study’s listing on ClinicalConnection’s website from a mix of organic website traffic and email outreach.
Web Sessions: Data showing the number of people who visited the recruitment website of the partner.
Inquiries: Individuals who made direct inquiries to learn more about the study.
Referrals: Patients referred to the study by through self-referral.
Screenings: The number of patients who completed pre-screening for eligibility.
Randomizations (Rands): The number of individuals who were successfully enrolled and randomized for treatment.

Recruitment Funnel Breakdown

Initial Outreach – 11,533 Members Reached: ClinicalConnection utilized a targeted outreach strategy to raise awareness of the trial among individuals who may have been affected by schizophrenia. We employed a combination of email campaigns and monthly newsletters to inform our database members of the study. Our outreach efforts reached 11,533 members who were diagnosed with schizophrenia or considered at risk of the disorder.

Listing Clicks – 14,930: Following the initial outreach, the trial's listing received 14,930 clicks, demonstrating that a substantial number of those who were reached engaged with the content and were motivated to learn more about the trial. Listing clicks are a critical indicator of how effective our campaign was at attracting interest, as they demonstrate a higher level of engagement compared to just seeing the ads. The clicks are from a mix of database members engaging with the content, as well as organic website traffic from people viewing the study after searching for trials on our website.

Web Sessions – 1,747: After clicking through to the trial website, individuals engaged with content about eligibility criteria, study locations, and the benefits and risks associated with participating in the trial. There were 1,747 web sessions. These web sessions help gauge the level of interest and the ability of the trial’s landing page to provide essential information. This data is important in understanding how well our messaging resonated with the potential participants.

Inquiries – 1,019: From the web sessions, 1,019 individuals reached out to inquire more about the trial, via phone, email, or submission of an online form. These inquiries represented the first direct step toward participant enrollment, with interested individuals seeking more information on what participation in the trial would entail. ClinicalConnection's follow-up communication provided potential participants with detailed information on the trial's logistics, compensation, and other pertinent details to help them make an informed decision.

Referrals – 477: 477 referrals were made through participants who expressed interest and were subsequently referred by ClinicalConnection to the study partner. Referrals were patients who, after inquiring about the study with our partner, were referred to complete the screening portion of the recruitment process. Importantly, 47% of inquiries resulted in referrals, displaying the effectiveness of our approach in converting initial interest into actual patient referrals for screening.

Screenings – 28: 28 individuals successfully completed the pre-screening process, where their eligibility was assessed based on inclusion/exclusion criteria. Given the trial's specific nature, the stringent criteria reduced the pool of eligible participants. Nonetheless, the completion of the screening process demonstrated that those who made it this far were genuinely interested and motivated to participate.

Randomizations – 9: Finally, 9 patients were successfully randomized into the trial, meaning these individuals were fully enrolled and assigned to the study to test the efficacy and effectiveness of the protocol. While the number of randomized participants is lower than the initial interest, this outcome is not unusual in clinical trials, particularly in psychiatric research, where eligibility criteria are strict, and many candidates may not meet all the requirements. Our partner was extremely satisfied with our recruitment and, overall, incredibly happy with the 9 randomizations.

Challenges Encountered

Strict Eligibility Criteria

Schizophrenia trials are particularly challenging because of the narrow patient population that meets the strict inclusion and exclusion criteria. In this case, only 28 individuals completed the screening, and 9 were randomized. This underscores the difficulty in recruiting for psychiatric trials, where the eligibility requirements and small patient populations often narrow the pool significantly.

Attrition in the Recruitment Funnel

The recruitment process showed significant attrition from initial interest (11,533 members reached) to final randomization (9 participants). This is typical for many clinical trials, especially those with a specialized focus like schizophrenia, where many individuals who express interest do not meet the necessary eligibility or choose not to participate after learning about the study requirements. However, 9 randomizations for this study illustrated that the recruitment efforts were a resounding success.

Communication and Education

A key challenge was ensuring that potential participants fully understood the requirements and benefits of participation. Our strategy included detailed information on the trial’s landing page on ClinicalConnection, further information on the study’s website, direct communication with interested individuals, and monthly follow-ups to remind the patients of the study opportunity.

Key Success Factors

Strong Digital Engagement

The trial achieved 14,930 listing clicks, indicating that our digital marketing efforts were successful in capturing attention and driving interested parties to learn more about the study. The targeted outreach strategy combined with clear, informative messaging was an essential element in generating initial interest.

Patient Referrals

The 477 referrals highlight the effectiveness of ClinicalConnection’s approach with targeting interested patients for this campaign. Additionally, the 47% inquiry-to-referral rate is a strong indicator of how well our follow-up strategies engaged potential participants and helped move them through the recruitment funnel.

Clear and Comprehensive Information

Having a well-designed, informative recruitment website that clearly explains the trial process, eligibility criteria, and expectations for participants was crucial in converting initial interest into inquiries and, eventually, screening.

Client Feedback and Success

The client was extremely satisfied with the outcomes of the recruitment campaign. Despite the inherent challenges of recruiting for a schizophrenia trial, ClinicalConnection’s efforts led to a prominent level of engagement, with over 14,000 listing clicks and nearly 1,000 direct inquiries. The 477 referrals demonstrated the effectiveness of our targeted outreach in connecting with potential participants.

Conclusion

Despite the challenges associated with recruiting for a schizophrenia clinical trial, ClinicalConnection successfully executed a recruitment strategy that effectively raised awareness, engaged potential participants, and enrolled 9 patients into this Schizophrenia trial. This recruitment campaign provided valuable insights into the complexities of patient enrollment in psychiatric trials, and our study partner was delighted with the results of the campaign as they understood the difficulties in recruiting for this trial due to the narrow patient population and stringent study criteria.