The Latest in Clinical Trial Recruitment: Lab-Validated Referrals

Clinical trials are increasing in complexity as the volume of available patient data grows. Today, trials may seek out patients with specific genetic mutations or lab values from a blood test. And while the science behind these requirements may be sound, detailed requirements make clinical trial patient recruitment even more difficult for trial sponsors.

At research sites, this increase in complexity often means that more patient referrals are unqualified for a given trial. That means more time is spent at a site screening patients who aren't able to participate in the trial.

Drug sponsors are looking for ways to quickly and efficiently reach the right patients to meet these complex criteria and avoid costly delays – while creating an engaging patient experience, too.

Precision-targeting for patient recruitment

An emerging approach to identifying specific patient populations involves connecting with companies that offer lab-validated referrals. A recruitment company may work with a lab, such as Quest, to reach out to patients whose lab values from recent blood tests match the inclusion/exclusion criteria for the study. While a study site may require an additional screening before the patient may enroll in the study, patients who are contacted in this way are much more likely to meet the study criteria.

Another option is for the patient recruitment agency to cover the lab validation step that is usually performed at a patient's first site visit. For example, Antidote partnered with PWNHealth to conduct direct-to-patient lab services. By the time patients reach the research site, they've already had a lab test done and confirmed that their values meet the eligibility criteria for the study.

This approach also cuts down on the medical procedures that need to be done at sites, reducing time and resources spent at the site level, as well.

Improving the patient experience

In addition to improving how trial sponsors reach patients, it's also critical to design clinical trials that reflect real-world patient populations. Companies with relationships with labs can also help provide feasibility services to give your team a sense of how many patients with a particular value they have in their database, for example.

While asking patients to visit a lab before signing up for a trial is helpful for the trial team, it can create a larger burden on the patient. It's important to create value for patients by designing trials that meet their needs, as well as by offering accommodations such as a free blood test or travel services.

If you're considering working with a company that offers lab-validated referrals, ask about how they account for the patient experience, too. The best patient recruitment approaches account for the patient's needs first – the needs of the research site and study sponsor naturally follow.