Unprecedented Success: Reaching Record Recruitment in Wet AMD Ophthalmology Study

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Unprecedented Success: Reaching Record Recruitment in Wet AMD Ophthalmology Study

project-details
Client:

Category
Duration:

Three Months

Website Link:

Background:

Sapientia Medicus Research involved in a recent Phase III clinical trial focusing on Neovascular (Wet) Age-Related Macular Degeneration (AMD). This study was crucial in evaluating a new treatment’s efficacy, and the timeline posed a significant challenge, requiring rapid patient recruitment. The project demanded that the recruitment phase be expedited without compromising quality or protocol adherence.
Ophthalmology

Challenges:

The primary challenge was meeting the recruitment goals within a highly condensed timeline. As this was a Phase III trial, patient recruitment was critical to ensure that the data generated would be sufficient for regulatory submissions.
The trial’s success depended on:
  • Strict enrollment timelines: Achieving accelerated recruitment while maintaining patient safety and adherence to trial protocols.
  • Complexity of the condition: Neovascular AMD is a specialized condition, making it harder to identify suitable patients.
Ophthalmology

Approach:

To meet the demanding recruitment goal, Sapientia Medicus Research employed a multi-pronged approach:
1. Patient-Centric Outreach:
The team employed targeted patient outreach strategies by partnering with ophthalmologists and eye care centers in key regions to identify potential patients early in the trial. These partnerships were essential in streamlining the referral process.
2. Optimized Site Management:
The two selected trial sites were strategically chosen to cover diverse geographic regions with high concentrations of Neovascular AMD patients. This allowed the research team to cast a wide net for recruitment. Each site received comprehensive support in terms of resources, training, and oversight to ensure protocol adherence and swift enrollment.
3. Accelerated Pre-Screening Process:
Pre-screening for patient eligibility was optimized through a rigorous, centralized screening process that minimized delays and ensured only suitable candidates were enrolled. This contributed significantly to hitting recruitment targets faster.
4. Flexible Recruitment Strategies:
The team adapted their recruitment methods based on the local demographics and healthcare infrastructure at each site. Some sites used digital campaigns, while others relied on patient registries and direct physician referrals.
5. Close Collaboration with Investigators:
Continuous communication and collaboration with investigators at all sites helped identify and resolve potential bottlenecks quickly. Regular feedback loops ensured that recruitment goals were aligned with site capabilities.
Results:

Primary Recruitment Target Met

The recruitment goal for the study was reached in just three months, well within the required timeframe.

Total Sites

18

Total Patients Recruited

184

Highest Patient Recruitment from a Single Site

26

This achievement was a testament to the efficient coordination between Sapientia Medicus Research and the clinical sites, as well as the use of innovative recruitment strategies. Not only did the team meet their timeline, but they also ensured that the data collected was robust and met the stringent quality standards required for a Phase III trial.

This success highlights Sapientia Medicus Research’s capability to deliver on even the most challenging recruitment goals, ensuring timely and high-quality data collection essential for the advancement of treatment options in ophthalmology.