Making connections: How Quest Diagnostics streamlines clinical trial site selection and recruitment

Quest is helping trial sponsors and contract research organizations (CROs) quickly find the trial participants they need.

Clinical trial enrollment has never been easy, and it’s certainly not easy today. Two statistics illustrate the challenge—and the opportunity—trial sponsors and CROs face:

• More than 80% of clinical trials in the US miss their enrollment targets¹
• 75% of patients would enroll in a clinical trial if they knew one existed²

“We all benefit when willing patients connect with open trials,” says Parag More, executive director, Healthcare Analytics Solutions - Life Sciences at Quest Diagnostics. “Our goal at Quest Diagnostics is to help make those connections.”

Today, Quest makes those connections in 2 key ways. First, it helps sponsors and CROs identify optimal trial sites. Second, it identifies and connects eligible patients to trials for accelerated recruitment. And in both cases, it works to boost involvement of people from underrepresented communities.

To do all this, the company leverages its unparalleled database of lab results. As America’s leading provider of diagnostic information services, Quest processes more than 500 million lab samples for over 200 million patients each year. That means the company can use near-real-time lab data to support trial sponsors and CROs.

This data covers a broad array of health conditions. Although some patients only know Quest as a place to get complete blood counts and pre-employment drug tests, the company offers more than 3,500 lab tests, including about 1,500 esoteric tests and about 900 genetic tests. Therapeutic areas it touches include neurology, cardiovascular health, women’s health, infectious diseases, rare diseases, oncology, dermatology, and nephrology.

Identifying trial sites

“Trial success begins with site selection,” says More. “We can query our database to identify geographical areas at a zip code level with high concentrations of eligible patients.”

For example, a trial sponsor studying a therapy to address chronic kidney disease might focus on zip codes where large numbers of patients have estimated glomerular filtration rate (eGFR) and urine albumin-creatinine ratio (uACR) results that are out of range. With that data in hand, the sponsor could identify likely optimal trial sites, healthcare providers (HCPs) whose patients meet the study’s criteria, and even potential principal investigators (PIs) or co-PIs.

Identifying trial participants

Quest Diagnostics can also help sponsors and CROs connect with qualified trial participants. Recently, the company helped accelerate a research study to identify patients with hyposmia (smell loss), which affects just 3% of the US population.³ To make this task even more challenging, the patients had to be at least 60 years old and not have Parkinson’s disease. Quest identified and contacted more than 60,000 potential subjects, more than half of whom visited the recruitment webpage. About 7,500 completed a screening consent, and nearly 400 patients with hyposmia were identified.

Quest didn’t just identify potential trial participants; it also connected them to the study. “We’ll find the people, and then we’ll conduct a patient email and/or direct-mail campaign based on IRB-approved collateral,” More says. “The messages can be co-branded and include study information, eligibility details, and links to the study webpage.”

Moreover, Quest can connect directly with healthcare providers whose patients meet trial criteria. Since three-quarters of trial participants are referred by their providers, driving trial awareness among physicians is a key to success.

Improving clinical trial diversity

People who identify as female or as members of racial and ethnic minorities are often underrepresented in trials. Since Quest Diagnostics tracks demographics such as age, gender, and sometimes ethnicity, trial sponsors and CROs can more easily meet diversity goals. For example, by combining zip code radius mapping with demographic information, it can help identify and include trial sites that serve underrepresented populations.

Such actions help ensure that trial participants accurately reflect the populations most likely to benefit from the interventions being tested. Many biopharma companies remain committed to increasing enrollment of people from historically underrepresented groups.

Quest Diagnostics believes it’s time for traditional recruitment strategies to evolve, offering better precision in identifying, reaching, and enrolling participants who clinically fit specific trial requirements and who accurately represent the population an intervention is being developed to treat. Thanks to its vast storehouse of data, that’s just what’s happening for many trial sponsors and CROs.