Screen Failure in Clinical Trials: Improving Reconciliation
More often than not, researchers face screen failures during the study activation process. Screen failures occur when research staff put potential participants through a screening process to ensure they fit the inclusion criteria in a study, only for them to not enroll in the trial. Standardized screen failure data in clinical trials is hard to find, and 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 the 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 may not always be accurate. Notably, 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 ineligibility. A person may not meet a study’s inclusion criteria for reasons such as 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 (CTMS). This software provides a single database for sites to maintain important information like participant histories and records.
When identifying potential participants for upcoming trials, recruiters can easily search the CTMS for strong matches. To enhance these efforts, researchers are able to 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 to the 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 hurt future collaboration.
Find the Right Fee Structure
Once a rate is estimated, contract research organizations (CROs) and sponsors can determine a reasonable fee structure 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.