ClinOops #2: Beating Site Burden
How sponsors, sites, and patients can hold hands and work together
“The scary truth is that sites don’t need our study.”
I heard this from a sponsor recently. It revealed an interesting shift in mindset.
Increasingly, established sites have the pick of their studies. And when it comes to picking, sites don’t have time for studies that make things harder on their teams.
We’ve all heard about site burden. Let’s talk about what we can do about it.
🚧 The Root Causes of Site Burden:
Limited Resources: Funding, personnel, and infrastructure are key, but sometimes they're hard to come by. In particular, staffing has gotten harder over COVID.
Personnel Turnover: High turnover means training new hires while managing ongoing trials.
Trial Complexity: We've all seen trials getting more complex with intricate designs and eligibility criteria. Constantly changing protocols and processes make training impossible.
Increased Operating Rigor: We all know that GCP and data collection in a clinical trial requires more time and effort.
Coordination Complexity: Site staff have a constantly growing study team to coordinate and check in with across Sponsors, CROs, and vendors.
Patient Recruitment: Finding and retaining eligible participants is getting harder. And the role of the CRC in the patient journey is expanding. CRCs are underwater.
Tech Overhead: We’ve all seen the stats: the average site needs to use 6 different technologies per study.
💡 How Sponsors As Supporting Sites:
Staffing Support: Sponsors can provide extra hands through staffing augmentation to fill in the gaps. The most successful sponsors on Power have been supporting their sites with an extra pair of hands to coordinate with patients.
Integrated Technology Solutions: We’re seeing more sponsors elect for technology that “plays nice with others”.
Edu-tainment: Sponsors can invest in bite-sized training resources that are educational and engaging.
Simplify Study Design: Sponsors can work with sites to simplify protocols and reduce unnecessary complexity.
Data-Driven Site Feedback: We’ve helped sites communicate bottlenecks and recruitment challenges back to sponsors using data.
Recruitment and Retention: Sponsors can offer tools and support for patient recruitment and retention efforts.
Sharing Best Practices: We’ve seen sponsors share success stories and insights across sites to make sure the study is learning as it goes.
The bottom line: site burden is everyone’s problem. It affects the patients, it affects the site staff, and it affects the sponsors.
To overcome this, sponsors, sites, and patients need easier ways to collaborate in real time. Feedback should be bi-directional. And challenges should be transparent.
Curious to learn more? Check out our piece on building a Modern Clinical Trial Marketplace
PS: I’m going on a LinkedIn Livestream with Brad Hightower tomorrow at 9am PT / 12pm ET. Would love to see you there 👋