Leveraging Standardized Data to Streamline Site Feasibility

Efficient site feasibility is essential for successful clinical trials. What is also necessary is collaboration. A leading biotech company partnered with WCG to improve their site feasibility process by addressing inefficiencies and disparate data. The adoption of WCG’s Total Feasibility solution enhanced study planning by engaging necessary expert resources and leveraging technology to streamline data to make informed decisions.

Challenging Realities of Today

Study start-up is commonly prone to delays due to the involvement of various stakeholders, technologies, and interdependent decisions. One decision that can greatly impact the success of a study is determining which sites to partner with. Unfortunately, the traditional feasibility process is inefficient and fragmented with multiple sites, sponsors, and CROs reaching out to the same investigators with the same questions.

In a study by the American Society of Clinical Oncology (ASCO), a clinical trial site receives a median of five feasibility questionnaires per month. Within those questionnaires, around 85% of questions are redundant across sponsors/CROs as well as within the same sponsor/CRO. According to recent research by the Tufts Center for the Study of Drug Development, an average of 200 hours are spent each month per investigative site completing feasibility assessments and site qualification visits for FDA regulated industry-funded clinical trials.

When combined with the known obstacles of physician retention and participant recruitment, the amount of time answering redundant questions would be better allocated to solving for participant recruitment challenges.

Best Practices for Site Feasibility

One of the primary difficulties in site feasibility is the consolidation of disparate data on sites. This includes information on past trials, site capabilities, and investigator profiles. To address this, it is essential to standardize data collection. By consolidating disparate data into a single, unified data source, organizations can ensure a comprehensive view of potential sites and facilitate informed decision-making. Additionally, utilizing a standardized question bank mapped to site and investigator profiles ensures 100% data reusability, reducing redundancy and ensuring consistency in data collection.

When standardized data is in play, an organization can begin to implement predictive analytics. Predictive analytics have a crucial role in site selection by effectively integrating back-end algorithms to structure the subjective opinions of key stakeholders and connecting key datapoints needed for decision making. Implementing these analytics allows for a data-driven approach, making the site selection process more objective and reliable. Integrating custom scoring of survey responses to support a uniform review of sites ensures that feedback from multiple stakeholders is built into the site scoring algorithm, removing subjective components from site selection. This objective approach helps identify sites with the highest potential for success.

However, regardless of the increase in data usage, analytics, and improvements in the site identification process, site feasibility still requires outreach to the sites to ensure that they are interested in participating in the clinical trial in question. During this phase of the site selection process, collaboration and communication are key components of an efficient site feasibility process. Using pre-configured surveys with standard questions and electronic confidential disclosure agreements (CDAs) help to streamline the process, making sites more likely to participate due to the emphasis on efficiency. Similarly, establishing tailored communication channels where the site is asked to validate the information we know about them, as opposed to re-answering the same questions, facilitates close collaboration between sponsors and sites, ensuring efficient interactions.

Focusing on improving the overall site experience builds stronger, long-term relationships with sites. This includes understanding the holistic view of site capabilities, interests, staff, and logistics, and doing more efficient outreach for future trials when you understand the core capabilities and interests of each individual site. When multiple stakeholders contribute to outreach, including medical science liaisons (MSLs) within the sponsor organization or a designated CRO, transparent and centralized reporting with clear and actionable interaction histories enhances transparency and accountability, while allowing a sponsor to see their entire investigator footprint throughout their organization.

Setting up for Success

Sponsors and CROs can streamline the site feasibility process by leveraging innovative approaches and best practices. Unlocking data and insights for more precise sites matched to a study reduces burden and creates faster response times from potential sites. WCG’s Total Feasibility solution can help sponsors and CROs address key challenges, enhance process efficiency, and build stronger relationships with sites. These best practices can serve as a valuable guide for organizations looking to improve their site feasibility process and achieve greater success in their clinical trials.

References:

1. ^{Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement: https://ascopubs.org/doi/10.1200/OP.20.00821}
2. ^{Benchmarking the Investigative Site Qualification Process: https://www.appliedclinicaltrialsonline.com/view/benchmarking-the-investigative-site-qualification-process}