With the rise of biologics, precision medicine, and AI-driven drug discovery, clinical research has entered a new and complex era. As advanced therapies—including cell and gene therapies (CGTs) and specialized treatments for rare disease—make up an increasing percentage of the pipeline, eligible patient populations are shrinking. Generating meaningful evidence from smaller cohorts can be easier with innovative trial designs, so single-arm, adaptive, and basket protocols are becoming more common. Individualized dosing schedules often require non-standard safety and efficacy assessment schedules, while regulatory expectations about the quality of submitted data—and the diversity of trial participants—continue to increase.
Given these challenges, it’s no surprise that pharmaceutical companies and contract research organizations (CROs) are relying more heavily on diagnostic laboratory partners to perform sample collection and testing for clinical trials. As trials become more complex, and patient recruitment more difficult, clinical lab testing demands increasingly specialized expertise and infrastructure, which an expert partner can easily and cost-effectively supply. In one recent survey of industry stakeholders, 80% said they would be likely to outsource laboratory and diagnostic testing in their trials, making this the most-often-outsourced aspect of clinical drug development.
A diagnostic laboratory partner with extensive experience supporting clinical trials can help sponsors find and engage qualified participants more quickly and cost-effectively than they could on their own. Amidst today’s competitive research landscape, access to the right testing capabilities can be make-or-break for R&D success. But with record growth in the outsourced testing services market leading unprecedented numbers of unproven newcomers to enter the field, it’s harder than ever for drug developers to find a diagnostic testing partner they can rely on.
“When you work with an industry leader, you get access to the broadest-possible array of tests, capabilities and solutions,” says Rob Dottori, director of private payer and virtual markets at LifeLabs. “With technology changing so quickly, you need a testing partner who continues to innovate every day. But you also want a partner who is established enough to have earned the trust of communities and providers, with a proven track record of reproducibility and precision in its testing.”
Here are the top three ways the right diagnostic laboratory partner can facilitate clinical trial success:
1. Streamline and Increase recruitment
As medicine becomes more personalized, recruiting and enrolling qualified clinical trial participants is increasingly challenging. Without access to a sufficiently large and diverse patient population, the study won’t deliver scientifically rigorous, generalizable findings that satisfy regulators—if it can be completed at all. As many as 20% of cancer trials fail due to lack of enrollment.
A diagnostic laboratory testing partner that operates a large network of Patient Service Centers (PSCs) across an extensive geographical footprint can help sponsors overcome these recruitment challenges. Look for a testing partner with a strong online presence who can activate targeted recruitment campaigns across a pre-existing network of patients and healthcare providers (HCPs). Some labs will even maintain a list of patients who have explicitly consented to receive emails about clinical trials and other research opportunities. It’s also critical to find someone who can provide supportive, convenient experiences for trial participants.
“LifeLabs is the largest and most trusted laboratory in Canada,” Dottori says. “Even more importantly, patient-centricity is in our DNA as an organization. We provide flexible booking and scheduling services to make sample collection easier for patients. We also support decentralized trials, making it possible to reach patients who don’t live close to a research facility. And we offer mobile sample collection kits, extending our support all the way into the homes of patients.”
2. Ensure data integrity
Your diagnostic testing partner should leverage automation to support granular sample tracking, minimize human error and enable consistent results reporting at scale. This requires the right technology and data management infrastructure. Your testing partner should also support real-time results reporting and deep integrations that make it possible to securely distribute medical information to key clinical research stakeholders across your organization.
Not only should your diagnostic testing partner have a thorough understanding of all relevant federal and provincial data security, privacy and quality assurance standards, but they should also conduct regular internal audits and process reviews to ensure ongoing compliance.
3. Maintain stakeholder trust
The value of a testing laboratory’s reputation cannot be overstated. When your lab has a long history of delivering reliable results—one that’s well-known among HCPs and clinical researchers—your trial’s credibility will immediately be enhanced. And when a diagnostic testing service provider is recognized for delivering exceptional patient care and experiences—as LifeLabs was when it was named the Most Trusted Brand in Health Diagnostic Services—this speaks to the strength of its patient focus.
“Our oversight helps ensure every process supports accuracy, patient safety and trusted results,” says Phillip Morehouse, director of quality and regulatory affairs at LifeLabs. “Every result we deliver is a testament to the quality of our work and the dedication of our teams. We’re proud that our commitment to excellence and continuous improvement across the entire organization ensures results that Canadians can trust.”
Visit us online to learn more about how LifeLabs is helping leading CROs, academic researchers, biotech companies and pharmaceutical innovators achieve clinical research success.
