3 Ways to Improve Screen Failure Reconciliation in Clinical Trials

Taking the correct steps to mitigate screen failure risks

Standardized screen failure data is hard to find; results across different types of studies are rarely published. One review of clinical trials for genitourinary cancer placed the mean screen failure rate at approximately 20 to 30 percent; other studies for Alzheimer’s posted rates of 70 to 80 percent.

Even rates on the lower end of that range can pose a problem for research organizations. This is because they must commit their site personnel, budgets, and more to identifying and screening potential study participants. Yet despite allocating this money and resources, it’s still possible that up to four out of every five individuals a research site screens for a study may never contribute data to it.

Study sponsors help compensate sites for this time and effort, but these payment models have issues as well. Most worrisome are instances in which sites appear to screen anyone—whether they’re a good candidate or not—simply to earn a fee. This possible insinuation is further reason why research sites must be vigilant in mitigating screen failure rates.

To avoid such negative outcomes, research organizations and those who manage clinical trials can do these three things to improve screen failure reconciliation.

Optimize Patient Recruitment

The most common cause of screen failure is patient ineligibility. A person may not meet a study’s inclusion criteria for many reasons: age, gender, medical history, etc. Even if someone initially meets these criteria, he or she may still refuse to participate in a study—perhaps after learning more details about its duration or potential risks.

To help avoid these issues, research organizations and sites should utilize an effective clinical trial management system, or CTMS. This software provides a single database for sites to maintain important information like patient histories and records.

When identifying potential subjects for upcoming trials, recruiters can easily search the CTMS for strong matches. To enhance these efforts, researchers can note individuals’ screening histories within their file, including if they previously failed a screening and why. This can prevent the same negative outcome from happening twice.

Set Appropriate Expectations

Finding published screen failure rates for specific studies can be difficult, but clinical research organizations must try to set appropriate expectations with the study’s sponsor. If you use a CTMS, look at the recorded rates for past studies you’ve conducted. Also, reach out to those who have undertaken similar research or share your trial’s specialty to see if they will share this information.

If a trial is going to have a failure rate closer to 80 percent than 20 percent, you must communicate that information to the study’s sponsor upfront. Otherwise, they may question whether you’re bringing in extra, unqualified applicants simply to earn additional failure fees. This type of ill will and distrust can obviously hurt future collaboration.

Find the Right Fee Structure

Once a rate is estimated, CROs and sponsors can determine a fee structure that makes sense for both parties. Ultimately, finding a fee you can agree upon might not be able to reduce screen failures. However, it will go a long way toward reducing dissatisfaction between sponsors and sites, which is also an important aspect for success.

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