Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Recruitment Success
Background
SubjectWell was engaged to support recruitment for an ADHD clinical trial that faced multiple delays. The study was initially postponed due to the sponsor pushing out First Patient In (FPI), followed by internal staffing challenges within the Contract Research Organization (CRO) and significant delays in Institutional Review Board (IRB) approvals due to a system update. Despite these obstacles, SubjectWell quickly demonstrated success in providing qualified patient referrals, leading to their inclusion in a second, related ADHD study. Across both trials, SubjectWell facilitated a total of 164 ADHD randomizations.
The Challenge
The study encountered several recruitment roadblocks:
- The sponsor delayed FPI, causing a slow start to enrollment.
- The CRO experienced internal staffing issues, affecting recruitment operations.
- IRB approvals were significantly delayed due to a system update, further impacting timelines.
- The study required high patient engagement and seamless tracking of referral statuses across multiple sites.
The Solution
SubjectWell leveraged its extensive direct-to-patient recruitment platform to address these challenges:
Efficient Patient Referral Process
SubjectWell generated a high volume of referrals, ensuring a steady pipeline of potential participants.
Collaboration with CRO and Sites
Worked closely with the CRO and site teams to streamline patient tracking, utilizing IVRS reporting and the SubjectWell portal.
Accelerated Recruitment
Delivered 37 randomizations for the first study (over four months) and 127 for the second study (over seven months), significantly improving enrollment rates.
Extended Engagement
Due to the success of the initial recruitment, the contract was extended twice, and SubjectWell was brought in to support a second study.
The Results
SubjectWell helped bring in Last Patient In (LPI) 3-4 months earlier than site-only recruitment, demonstrating the effectiveness of guided recruitment strategies for ADHD clinical trials.
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