“The question we must all ask ourselves is ‘What can we do to help sites overcome their challenges?’” asks John Kennett, Global Marketing Director at Fortrea.
It’s an important question, and one that has become increasingly pertinent as medical research advances, with more intricate and adaptive study designs, extensive data collection requirements and sophisticated analysis plans emerging. At the same time, the increase in complexity means trials are targeting more specific patient populations, leading to increasing competition for limited numbers of participants, investigators and sites.
Productivity in clinical trials is perhaps best viewed in terms of the trial’s ability to remain on budget and avoid delays, without compromising on safety or data quality, with metrics such as last-patient-in (LPI) used as an important measure for sites. While rapid first-patient-in (FPI) progress indicates speedy start-ups, LPI gives a more rounded view of the site’s ability to progress the study.
With overall trial productivity as strong as its weakest site, the more that can be done by all stakeholders to anticipate, mitigate and respond to minor inefficiencies at sites accumulates into major benefits for the entire study.
Pre-empting the problems
To avoid delays in clinical trials, sponsors, CROs and sites should be laser-focused on anticipating the logistical and clinical challenges that could occur, whilst establishing the foundations needed for open collaboration throughout the life of the trial.
For the best results, this collaboration begins before the trial itself, starting with incorporating site feedback into protocol design to identify any challenging or overly complicated aspects of the protocol that could be simplified or improved. This collaboration should continue into site activation, with sponsors/CROs working closely with each site to ensure their readiness for the trial, addressing any gaps in equipment, supplies, or staff training before the study begins. This might include conducting dry-runs of studies to highlight any logistical issues ahead of time.
When it comes to technology’s role, using sophisticated tools to carefully select sites based on their catchment of the target patient population is pivotal in helping to set sites up for successful enrolment. Once enrolment commences, AI and other data-enabled technologies are also stepping up to support risk-based monitoring at both the site and study level. An example of how these tools can be used includes keeping an eye on enrolment and recruitment numbers across all sites, analysing trends and alerting sponsors/CROs when one team might be falling behind its targets. When combined with good CRA and study management practices – and an attitude of collaboration between all stakeholders – this data-driven approach can help identify potential concerns before they become problematic.
Amplifying the voice of the site
“As a CRO, part of our job is to manage big groups of sites across multiple geographies and do whatever is possible to help each one stay on track to deliver the trial on time,” says Fortrea’s John Kennett. He explains that merely employing a strategy of over-indexing on sites – activating perhaps 125% of the site capacity that the study technically requires to compensate for the sites that end up underperforming – is inefficient.
“All sites start out by wanting to provide high-quality data. No site will ever take on a study without being serious about wanting to execute that study to the best of its ability,” says Kennett. “The ideal is that every site does what it says it’s going to do, but in such a complex environment, we have to remain open and flexible to respond to challenges. Providing the mechanisms to measure performance and then interact and put measures in place to support sites is what makes the difference between success and failure.”
While Fortrea already offers its Xcellerate suite of data-enabled technologies to provide dynamic insights about study progress, the company is also championing the importance of close working relationships with sites across the entire lifecycle of a study. “Nothing replaces active, open dialogue as the best and simplest way to understand the challenges that sites are facing with workflows, complex protocols, administrative burden, etc.,” Kennett states.
“Sites are businesses, too, with cashflow and resource realities,” he continues. “Working collaboratively to understand the individual challenges means that steps can be taken to support that site. Employing this approach with each site on a study then has the cumulative impact of study efficiency and, ultimately, study completion.”
To learn more about how addressing site-specific challenges can increase trial productivity, please download the whitepaper below.
