Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate with research site teams to activate and execute clinical trials. Despite each stakeholders’ best efforts, there are persistent challenges regularly throwing studies off track and resulting in costly workarounds:

• Failure to achieve recruitment goals: About 20 to 50% of clinical trials will require “rescue”, where new sites are added to cure patient enrollment shortfalls. Ensuring every selected site can achieve their recruitment targets is essential to meeting study timelines and eliminating unplanned costs.
• Loss of patient data sets due to protocol non-compliance: The cost to recruit a new patient if one is lost due to non-compliance is an estimated $20,000. To maximize the investment in each activated site, it is important to not only monitor recruitment progress, but also site protocol adherence to retain adequate patient data.

When these challenges occur, it requires additional investment of unbudgeted resources and time. From the time a site is selected for your study, there is a critical window where study teams need to increase oversight to avoid these frequent study pitfalls.

Very often, study teams focus too heavily on recruitment progress, where it can take months for clear trends to emerge. However, there are other informative metrics which present themselves much sooner and allow you to take preventative action, versus costly reactive measures.

Key Risk Indicator #1: Have Site Staff Accessed Your Training System and Materials?

Just because you have distributed training materials does not mean your site teams have accessed or are familiarized with them. Leveraging an electronic system for training materials provides your team with more oversight into onboarding and training status of each site member and investigator. These systems are typically deployed at site activation and early adoption is a strong indicator of your site’s engagement.

Tip to reduce site burden: Consider how many systems you’re providing to sites on a particular trial (ex: electronic data capture [EDC], learning management system, etc.) and opt for ways to centralize access. In addition, providing all site training for your studies in a single location will reduce the challenge of finding and accessing essential training information for your sites.

Key Risk Indicator #2: Have Your Sites Completed Required Training, and are they Passing Training Evaluations?

In addition to overall training completion, knowledge retention and understanding is critical for an efficient and compliant trial. You should leverage systems designed to provide visibility into overall training completion, training documentation and certification routing, and ability to test for comprehension.

It’s also important to monitor site training beyond initial activation. With so many sites facing significant staff turnover, it is inevitable new site team members will need to get up to speed on your study. Continue to monitor training engagement and accuracy throughout the trial.

Tip to reduce site burden: Not all training materials are equal. Reduce site burden by providing engaging and concise materials beyond cumbersome brochures, like videos, to add to study-specific understanding. In addition, evaluate what training may be redundant, and explore ways to accept certain training completions across studies with the same sponsor to reduce duplicative burden on site teams.

Key Risk Indicator #3: Have Your Sites Acknowledged (Signed, Viewed, or Responded to) Essential Study Documents and Alerts?

This critical metric informs timelines and compliant conduct. Documents like signed informed consent forms (ICFs) indicate active recruitment activities. Additionally, acknowledgement of study communications, protocol amendments or safety letters are also an indication sites are working with the most up-to-date version of the protocol and are engaged with the trial.

If you’re using a system like email to facilitate document exchange or updates on amendments or safety notifications, you will likely lack visibility into the exact action of a site staff member. It is important to view status across delivery, opening, clicked, and acknowledged (or signed).

Tip to reduce site burden: We all experience notification fatigue. It is important to consolidate the number of notifications you’re sharing with sites, as well as centralizing them in a single system to provide them with an easy, actionable view of where their attention is most needed.

Key Risk Indicator #4: How Many Patients Were Prescreened? Is it an Appropriate Amount to Achieve Recruitment Goals?

Prescreening is an essential activity, laying the foundation for successful recruitment and is a reliable early indicator a site has commenced recruitment activity. We also know not every prescreened patient will be deemed eligible for your trial. Each trial has a conversion rate between the number of prescreened patients, those eligible, and those who enroll in the study as participants.

As study managers and CRAs, it is valuable to monitor both prescreening activities and associated conversion rates. This allows you to adapt targets based on real-time input, adjust efforts, and ensure you reach your desired recruitment targets. Technology reporting on common ineligibility criteria also enables sponsor teams to identify restrictive elements of their protocol.

Tip to reduce site burden: Prescreening is a numbers game – the more potentially eligible patients prescreened, the higher likelihood targets are achieved. Make prescreening simple and fast for sites with electronic checklists accessible via a variety of devices.

Efficient and compliant studies are a collaborative effort between study and site teams. Fit-for-purpose technology and proactive oversight of key risk indicators can support successful startup and execution of a trial, while minimizing administrative headaches for your sites.

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