Contract Research Organizations (CROs) and vendors stand as pillars in clinical trials, with sponsors thoroughly building Key Performance Indicators (KPIs) to monitor and ensure their performance. However, the site’s perspective is a crucial, often overlooked component in assessing vendor and CRO performance. Despite the paramount role of clinical study sites, their unique and essential viewpoint on CRO and vendor performance remains unheard, impacting clinical trials’ overall success and effectiveness.

The Underestimated Value of Site’s Perspective in CRO Performance

In a recent SOS Save Our Sites (SOS) event, significant concerns of study sites were highlighted, primarily focusing on ensuring the smooth operations of clinical trials. In my experience, despite the sites’ pivotal role, the sites’ voices often get overshadowed amidst the various operations and vendors managing the clinical trials, including evaluating CRO and vendor performance. While essential, these KPIs often miss out on the granular, on-ground challenges the sites face, leading to substantial oversight. This oversight frequently results in a disconnect, affecting the real-world insight into the actual implementation and challenges of clinical trials, such as patient recruitment, retention, and technical problems with data collection devices. Consequently, it impacts the ultimate goal of ensuring patient centricity and the successful execution of clinical trials. Integrating the site’s perspective into the assessment of CRO performance is not just a recommendation but a necessity to bridge this gap, ensuring a more holistic, realistic, and effective evaluation and operation of clinical trials.

Challenges: Communication and Collaboration in CRO Performance

During the event, speakers amplified the call from study sites for enhanced communication and collaboration among all stakeholders, including patients, sponsors, and CROs. The speakers reveal a collective emphasis on paying attention to each voice in the clinical trial process. It’s about a proactive rather than a reactive approach, ensuring clinical trials’ smooth functioning and success. The participants discussed the significance of having mechanisms for engaging with various stakeholders, including surveys and round tables, to gather feedback and insights. These platforms are seen as essential tools for understanding and addressing the concerns and challenges faced by study sites, ensuring their voices do not get lost in the broader clinical trial operations. The dialogue among participants highlighted the crucial role of one-on-one conversations, ensuring that concerns are personally heard and addressed. This direct communication pathway is vital for ensuring the successful and efficient execution of clinical trials, contributing to improved patient outcomes and the overall success of clinical research endeavors.

Real-World Examples: Overlooked Site Concerns

Envision a situation where a site encounters technical issues with study data collection devices or other technology that the CRO is responsible for managing. The malfunctioning or inefficiency of these devices can severely impede the accurate and timely collection of essential trial data, creating protocol deviations and potentially jeopardizing the entire study. Despite the urgency, these concerns might not reach the sponsor if the communication channels are not robust and clear. A CRO, evaluated solely on traditional KPIs, might overlook these vital issues, underscoring the necessity to embed the site’s perspective in the assessment metrics. When not addressed promptly, such technical issues can lead to massive data inaccuracies, protocol deviations, delays in study timelines, and increased operational costs, further emphasizing the critical need for including the site’s feedback in assessing CRO and vendor performance.

The sites’ practical insights and timely feedback are instrumental in identifying and resolving issues that might otherwise go unnoticed in the conventional CRO and vendor assessment framework, thus affirming the importance of integrating the site’s perspective in the evaluation process.

Recommendations for Sponsors

Regular conference calls with sites are common, yet they often fail to facilitate genuine dialogue and feedback from study sites. Despite the open forum, study sites frequently remain silent, their concerns unvoiced and unaddressed. This silence could stem from various factors. Sites might feel their concerns will be overlooked or may lead to unintended repercussions. The hierarchical structure in such calls (i.e., Key Opinion Leader sites versus independent sites) may also inadvertently suppress the voices of site representatives, making them hesitant to speak up.

In light of these insights, sponsors must delve deeper into understanding the roots of this silence and work towards creating an environment where sites feel comfortable and encouraged to share their feedback and concerns openly. This endeavor goes beyond merely holding conference calls. It includes fostering a culture of openness, ensuring that sites are assured of the value of their feedback and that their voices play a pivotal role in shaping the clinical trial processes.

Here are some recommendations sponsors can implement to amplify the site’s voice in clinical trials:

  1. Site Ambassador: Appoint a site ambassador at the sponsor level for sites to escalate challenges they cannot resolve with the CRO. The ambassador would also engage sites to obtain qualitative feedback on vendor and CRO performance, which can guide quantitative vendor and CRO performance data collection methods (i.e., surveys).
  2. Regular Surveys: Conduct regular surveys of study sites to obtain their feedback on CRO performance, focusing on communication, support, and the resolution of challenges.
  3. Incorporate Site Feedback in KPIs: Integrate site feedback into the KPIs and quality contracts used to assess CRO performance, ensuring a more holistic and realistic evaluation.
  4. Establish Clear Communication Channels: Define clear and open communication channels between study sites and CROs to ensure timely resolution of issues and challenges.
  5. Site-Centric Performance Metrics: Develop and include site-centric performance metrics in the CRO assessment to address site concerns and challenges adequately.

A Call for Comprehensive Assessment

In summary, integrating the site’s perspective into the CRO and vendor quality assessment is beneficial and essential for a holistic and realistic evaluation of CRO performance. It ensures the resolution of ground-level challenges, contributing to the enhanced success and efficiency of clinical trials. As the ultimate goal remains the availability of effective patient therapies, recognizing and addressing the site’s perspective is paramount in achieving this objective.