Clinical trials are neither simple nor easy to conduct. Handling a study is extremely expensive, with the ever-increasing costs and complex site selection process. To put the statement in perspective, a completed clinical trial costs anywhere between $44 million and $115 million on average!
Site selection is a significant aspect of clinical trials as it is one of the first steps after the sponsors/CROs decide on conducting a trial. The outcome and success of the trials also depends on the selection of the site, which directly impacts the patient recruitment for the study.
But several inefficiencies and challenges associated with the site selection make it a painstaking process for the sponsors and CROs. It costs around $50000 per trial to open an investigator site on average and even then, 11% of sites fail to recruit at least one patient!
This is precisely why there is a need for best practices for site selection in clinical trials. Without implementing any such practices, the trial will be chaotic, and the results will prove costly for the sponsors and CROs. So today, we are going to discuss in detail the importance of site selection, the associated challenges, and the best practices for site selection in 2024 that will ensure success of your clinical trials.
Why is Site Selection Important?
Site selection holds paramount importance in the success of a clinical trial. The sites chosen significantly influence patient recruitment and retention, directly impacting the trial’s outcomes. The efficacy of a trial heavily hinges on the capability of selected sites to attract and retain suitable participants, the experience of Principle Investigators (PIs), and the availability of clinical staff, which in turn impacts data collection and study timelines.
What are the Challenges in Site Selection?
Despite its pivotal role, site selection presents inherent inefficiencies and challenges. These obstacles often contribute to escalated costs and delays in clinical trial timelines. Factors such as the high expenditure required to establish an investigator site and the number of sites failing to recruit patients highlight the complexities and risks involved.
The financial burden of setting up investigator sites coupled with recruitment challenges doubles the strain on sponsors and CROs. The substantial cost per site and the notable percentage of sites struggling to enroll patients shows the considerable financial risks associated with subpar site selection strategies.
What are the Best Practices for Clinical Trial Site Selection in 2024?
Owing to the complexities and challenges, companies in the life sciences industry are constantly looking for better and efficient strategies to make their site selection process better. With 2024 just around the corner, there is an acute need for implementing effective strategies that can reinvent the wheel. Let’s delve into a few best practices that can ensure better clinical trial outcomes in 2024.
- Data-driven Approach
- Technology Integration
- Site Assessment
- Enhanced Collaboration
- Patient-centric Approach
Data-driven Approach: Employing advanced analytics and data-driven methodologies enables a more informed decision-making process in site selection. Leveraging historical data, patient demographics, and performance metrics from previous trials helps in identifying and prioritizing high-performing sites more effectively. This is exactly where our Site Insights platform can help you make the right decision with 360-degree insights about your desired trial sites.
Technology Integration: The integration of state-of-the-art technologies like AI, machine learning, and digital tools revolutionizes the site identification process. These advanced tools analyze vast datasets swiftly, facilitating the identification of suitable sites efficiently and accurately. We have integrated Generative AI technologies such as Predictive Analytics into our Site Insights for efficient site suggestions.
Site Assessment: Prioritizing sites based on strategic criteria such as patient demographics, geographical accessibility, and past trial success enhances the probability of successful recruitment and retention. This strategic evaluation assists in selecting sites with higher potential for successful trial execution. With Site Insights, you can get a bird’s eye view into critical trial site information including patient enrolment rate, PI experience, staff availability, and historical data for better assessing the trial sites.
Enhanced Collaboration: Fostering robust collaborations between sponsors, CROs, and investigator sites fosters a more cohesive approach to site selection. Improved communication, mutual understanding, and transparent partnerships facilitate streamlined processes and effective site management.
Patient-centric Approach: Tailoring site selection methodologies to prioritize patient convenience, engagement, and satisfaction is paramount. By emphasizing patient-centricity, trials can attract higher participation rates and ensure better retention, ultimately contributing to more successful trial outcomes. Our Site Insights can help you in taking a patient-centred approach by analyzing factors such as patient satisfaction, patient recruitment, etc.
What is in store for site selection in 2024?
The clinical trial site selection is all set for transformation in 2024. The synergy between technological advancements, a growing emphasis on patient-centric approaches, and the refinement of data analytics will shape the site selection best practices in 2024. Embracing these changes will greatly revolutionize the efficiency and cost-effectiveness of trials in the years to come.
Conclusion:
The implementation of these best practices in site selection for clinical trials holds the potential to mitigate the financial burdens and challenges faced by sponsors and CROs. By integrating data-driven strategies, harnessing technological innovations, and prioritizing patient needs, the process of clinical trial site selection in 2024 appears promising. These best practices offer the prospect of heightened efficiency and improved trial outcomes, ultimately contributing to better healthcare.
At Inductive Quotient Analytics (IQA), we have understood the complexities and hassles that sponsors/CROs face within the site selection process. In order to help simplify and make the site selection effortless, our clinical experts have built “Site Insights” – our very own GenAI-powered site recommendation platform.
With Site Insights, you can accelerate your study startup by selecting the trial site that fits your study needs in a jiffy. Want to know how? Reach out to us at hello@inductivequotient.com for a demo!