It’s All About Site Selection

Life Sciences Site Selection

Want to have a successful clinical study? You’re going to need patients. Selecting the right trial site is absolutely crucial to recruitment efforts.

When it comes to running a successful study, site selection is key. Site quality can be measured by its ability to recruit qualified participants and keep to schedule (amongst other factors, but we’ll save that for a future blog post). 

Exponential HealthPatient recruitment is a perennial challenge—indeed, many studies don’t reach their desired recruitment rates. So what can you do to achieve your recruitment goals? Much can be written on that subject (a book’s worth, probably), but in the scope of this blog post, we’re going to delve head-first into four key drivers: 

  • Patient-Centric Trial Design 

  • Optimized Site Qualification 

  • Proactive Site Monitoring 

  • Direct-to-Patient Engagement 

Patient-Centric Trial Design 

Clinical trial protocols must be tailored to ensure that inclusion and exclusion criteria are diverse and not overly restrictive. When designing a study, you must also consider the experience of both site staff and participants. Your goal is to ensure trial processes are streamlined and easy-to-navigate for all stakeholders. This simplification can lead to protocol adherence and, ultimately, a successful study. 

Patient recruitment is a perennial challenge—indeed, many studies don’t reach their desired recruitment rates. 

Optimized Site Qualification

You want to select a site that has a history of successful patient participation within your therapeutic area. Past performance often correlates with a site’s ability to recruit participants in the future. To inform selection decisions, sponsors should reference past site performance data from a variety of sources. To do this effectively, sponsors can leverage their repository of survey data and tie in external data sources (e.g., clinicaltrials.gov) for enrichment.

When selecting sites, you should also consider qualitative factors, such as the patient experience. These considerations include site accessibility (e.g., is it located near patients to mitigate burdensome travel?, or is it accessible to any participants with disabilities, etc.) and the quality of the site staff engagement with patients (e.g., post-visit follow-ups).  

Want to see how Unqork is reinventing clinical trials? Check out our recent webinar. 

Proactive Site Monitoring 

Ineffective recruitment can extend timelines and cost for trials, which is why early detection and remediation is crucial. Once a trial is in progress, you will need to monitor site performance and recruitment efforts to identify and engage with underperforming sites. 

Modern digital technologies can effectively monitor sites with little human oversite. If an underperforming site is identified, systems can be designed to automatically notify CRAs and CRMs to help them keep the trial on track. 

Direct-to-Patient Engagement 

Brand awareness, reputation, and early engagement are factors in a patient’s decision to participate in a trial. Online patient portals are crucial to participant recruitment and retention because they 1) inform the public about upcoming trials they may qualify for, 2) provide additional helpful information & resources, and 3) provide opportunities for patient feedback. Modern digital portals can also be used to integrate wearable data, collect patient-submitted details, and engage with patient advocacy groups. 

One last bit of advice: DON’T rely on paper-based processes for these efforts. Various technologies on the market can help amplify and optimize these processes while maintaining security and privacy. 

To learn more about the nexus of healthcare and technology, check out other recent entries in Exponential Health or email Olya

 

About the Author

Olya Ossipova

For the better part of a decade, Olya Ossipova has focused on digital transformation and innovation in healthcare. Prior to Unqork, Olya was the head of operations at a healthcare technology consulting firm, serving as general manager and consultant for clients in the healthcare, government, and nonprofit sectors.

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