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Enhancing Clinical Trials: Best Practices for Site Collaboration
Achieving Optimal Clinical Trial Performance with Strategic Site Collaboration
Jun 06, 2025
Achieving Optimal Clinical Trial Performance with Strategic Site Collaboration
In the recent IQVIA webinar, experts shared valuable insights on achieving optimal clinical trial performance through strategic site collaboration. This comprehensive discussion covered various aspects of patient and site engagement, recruitment strategies, and the implementation of innovative solutions to enhance clinical trial outcomes. Below is a summary of the key topics discussed during the webinar.
Designing a Patient and Site Engagement and Support Strategy
The webinar began with an emphasis on the importance of understanding different stakeholders in the clinical trial process. The experts highlighted the need to start with the sponsor's goals, whether the trial aims to bring a novel therapy to market for a vulnerable patient population or is focused on rapid market approval, as seen with COVID and RSV vaccines. Understanding the patient population involves reviewing the protocol and considering the patient's diagnosis, treatment journey, existing standard of care, and available therapies, which vary by country. Additionally, the importance of considering underrepresented populations and potential motivators and barriers to participation was stressed.
Assessing Patient Participation in a Clinical Trial
The process of identifying patients for the study was outlined, including whether patients would be identified through the site's database, community engagement, or healthcare providers. The discussion included the importance of understanding patient needs, such as finding or keeping patients, and the factors influencing patient participation, including the method of drug delivery, comparison to current treatments, and potential placebo. The burden on the patient was also considered, including the treatment period, site visits, and challenges related to childcare or time away from work. Financial and logistical support, such as home or mobile nursing, was mentioned as a way to reduce patient burden.
Challenges for the Site
The challenges sites may face were addressed, such as high-volume enrollment in a short period and the resources needed to complete assessments and manage data entry. Risk mitigation was highlighted as a key consideration, acknowledging that studies can fall behind in enrollment for various reasons. Patient recruitment providers like IQVIA can help accelerate enrollment in such situations.
Example Patient Engagement Strategy
An example of a cardiovascular outcomes trial was presented, describing the typical patient profile, including BMI, history of cardiovascular disease, and type 2 diabetes. The competitive landscape for patient identification was discussed, along with the need for community and online outreach and physician engagement. Retention was a major consideration, with potential side effects and needle phobia being factors that could lead to patient dropout. Patient education through animations or videos and the use of technology for ongoing engagement were suggested. Mobile and home nursing were also mentioned as ways to reduce patient burden.
Connected Devices and Patient Enrollment
The use of connected devices, such as Bluetooth-enabled scales, was discussed as a way to reduce the burden on patients by allowing frequent weigh-ins at home. The high patient enrollment volume required to meet the endpoint was highlighted, placing a significant burden on sites and site staff. To alleviate this, additional staff augmentation or site resources were suggested to reduce administrative burdens. Clinical trial educators can support ongoing site training and engagement to ensure the study remains a priority.
Real-Life Example of a Challenging Study
A real-life example of a study focused on obesity, type 2 diabetes, and cardiovascular events was shared. Recruitment was ongoing, and IQVIA joined midway through to accelerate the process. They implemented a direct-to-patient recruitment solution and clinical trial educators to help meet the target number of patients. Despite the competitive landscape and time pressure, IQVIA managed to gather valuable feedback from sites and adjusted their strategy accordingly.
Boost trial success with smarter site collaboration
Discover proven strategies to engage patients, accelerate recruitment, and exceed goals.
IQVIA's Recruitment Strategy
IQVIA's approach to supplementing site-based recruitment and mitigating challenges was explained. They assessed primary recruitment barriers and developed a strategy to accelerate recruitment, including a direct-to-patient campaign with engagement incentives for participating sites. The campaign utilized diverse platforms such as social media, traditional and digital advertising, and re-engagement strategies via email and phone. Clinical trial educators were deployed to boost site engagement and enrollment, creating site-specific recruitment plans for maximum impact.
Impact of IQVIA's Recruitment Efforts
The direct-to-patient campaign performed exceptionally well, exceeding all measured metrics. The team expedited the campaign in just 43 days, resulting in a faster influx of referrals and achieving 130% of the targeted patient goal. Clinical trial educators significantly contributed to increased screening and randomizations, leading to an overachievement of the enrollment goal at 102%. The study concluded over two weeks ahead of the planned last patient end date, accomplished within a short five-month deployment.
Leveraging Patient Insights for Recruitment Strategy
The importance of leveraging patient insights to inform patient engagement and recruitment strategies was emphasized. The challenges faced in engaging patients with major depressive disorder (MDD) were highlighted, and the need to create a strategy that resonates with them. By gathering real-world insights and feedback from an IQVIA patient community, they were able to understand the frustrations and lack of optimism among patients diagnosed with MDD. This understanding helped in crafting a creative brand and messaging that validated their diagnosis and fostered a sense of community. Engaging the full family unit was also recognized as crucial in encouraging participation.
Proactive Recruitment Strategy for MDD Study
The situation for a global study on MDD, conducted by a biotech company, was set up. The study aimed to recruit adults aged 18 to 65 and was fully outsourced to IQVIA for clinical conduct and project management. The proactive recruitment strategy aimed to keep enrollment ahead of projections despite the challenges posed by poor mental health literacy, stigma, and site-based screening limitations. The customer had placed a recruitment cap on sites, adding pressure on all sites to contribute. High screen failure rates due to drug use were identified as a significant challenge.
Solutions Implemented for MDD Study
The solutions implemented for the study included a direct-to-patient (DTP) recruitment campaign. The campaign utilized various channels such as digital advertising, classified ads, TikTok, and IQVIA's health marketing network. Continuous optimization of the campaign revealed interesting insights, such as the over 45 population being more likely to convert to randomization and the effectiveness of the online screener in filtering out drug abuse criteria. Patients were found to be more open and honest when answering pre-screen questions online compared to direct conversations with sites.
Role of Site Enablement Solutions
The role of site enablement solutions with onsite research assistance in addressing the high screening burden on sites was further explained. These solutions contributed to the success of the study by providing additional support for pre-screening patients and optimizing the recruitment process.
Conclusion
The IQVIA webinar provided a wealth of insights into achieving optimal clinical trial performance through strategic site collaboration. By understanding patient and site needs, leveraging innovative solutions, and continuously optimizing recruitment strategies, IQVIA demonstrated its commitment to enhancing clinical trial outcomes. If you are interested in learning more about how IQVIA can support your clinical trial needs, please contact them for custom solutions tailored to your specific requirements.