Many sites think the more studies they open, the better. However, quantity is not the best indicator of success, nor is it the most conducive to successful patient enrollment.
To prevent poor enrollment performance down the road, we share an excerpt from the free eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.” Here are a few questions sites must answer to avoid taking on studies that won’t accrue enough patients.
Do you have competing studies?
Taking on competing studies can often end up harming both trials. Look at your open to enrollment and pending studies to determine if there will be any overlap.
If they would compete but the study would otherwise be a good fit, clearly communicate your reason for declining to the sponsor or CRO to keep your site in mind for future opportunities and the relationship in good spirits.
Are you being overly optimistic?
It’s always better to underestimate than overestimate your enrollment forecast, as most trials end up doubling their original timelines to meet enrollment goals, and 48% of sites under-enroll study volunteers (Tufts, 2013).
Inflated enrollment estimates from sites are a huge problem for sponsors/CROs, as they often need to add more last-minute sites. Honesty is the best policy for healthy site-sponsor relationships and quicker clinical trials.
Have you looked at past performance metrics?
Sites can learn from past performance data of similar studies when considering future trials and making more accurate enrollment estimates. Look at the number of studies you are opening and closing each year, including how many you are successfully closing as a result of successful enrollment.
Many sponsors prefer objective evidence of performance, rather than just an estimate alone. Look at how consistently you have achieved timely First Patient In (FPI), as well as overall enrollment targets. Business intelligence tools like Forte Insights can help immediately provide actionable information into accruals with numerous dashboards and metrics to gauge enrollment performance.
What is the minimum number of patients you need to break even?
Do a break-even analysis to determine how many patients you would need to enroll for it to even make sense to take on the study. Consider the scientific, financial and resource (both physical and staff) perspectives.
Take staff outages and workloads into consideration, from a principal investigator (PI) going on sabbatical or maternity leave to assigning too many trials to any one study coordinator. Track staff effort to understand the time and effort needed from study startup through closeout and to calculate the true costs (including staff salary costs) involved in performing any given task.
Clinical research sites of all sizes are guilty of being serial trial openers, but more is not always better. Taking on studies that don’t enroll enough patients can cause challenges for the sponsor/CRO, patients and your site’s reputation.
Estimating patient enrollment will always be a bit of a guessing game, but sites must do everything they can to get it right. For more tips on predicting enrollment and finding better study opportunities, download the eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.”