This World Lung Cancer Day, the theme “Lung health for all” highlights the importance of raising awareness, improving education, and expanding access to care. Despite advances in lung cancer research, it remains the leading cause of cancer-related death worldwide, claiming 1.8 million lives in 2022. It also continues to receive disproportionately low research funding relative to its disease burden.
An FDA analysis showed that the number of US lung cancer trials that enroll 0 patients grew by almost 4x in recent years. If your trial is facing recruitment difficulty, you’re not alone, and the challenge may not be patient willingness. It could be that your recruitment strategies haven’t kept pace with how lung cancer has evolved.
To understand how sponsors can adapt, we spoke with Dilek Denizli, Vice President Recruitment Strategy at Clariness. Over the past decade, Dilek has helped sponsors navigate recruitment challenges across a wide range of therapeutic areas, with particular experience in designing global enrollment strategies for complex oncology studies. In this article, she examines the key patient- and disease-specific barriers affecting enrollment in lung cancer trials and shares insights on how sponsors can shift their recruitment approach to reduce these barriers and improve enrollment outcomes.
What are the key barriers for sponsors in lung cancer patient recruitment?
1. Patients can’t join a trial they don’t know exists
One of the greatest barriers to lung cancer clinical trials occurs long before sponsors launch a single recruitment campaign.
Patients are willing to participate but rarely get the opportunity. One study reports that 33% of adult Americans said they would participate in a clinical trial if asked, yet only around 3% of cancer patients ultimately enroll. One major reason is that physicians refer just 0.2% of their patients into clinical trials, creating one of the largest bottlenecks in the recruitment funnel.
The conversation often never happens or isn’t fully understood. Studies show patients recall and comprehend as little as 50% of what is discussed during a medical consultation, while low health literacy further limits informed decision-making. Healthcare providers themselves face barriers, including limited awareness of available studies, insufficient training, suboptimal referral pathways, and communication challenges. Even when patients are offered a clinical trial, education remains a challenge. One study found 56% of patients who declined participation said they felt overwhelmed by the information they received, while another reported that 40% of newly diagnosed cancer patients declined participation despite having access to a trial.
These barriers disproportionately affect underserved populations. Among eligible lung cancer patients, black patients are 50% less likely to enroll in clinical trials than White patients. Physicians identify lack of patient awareness, mistrust, and perceived trial burden as major barriers to participation. Importantly, studies have also shown that when racial and ethnic minority patients do participate in cancer clinical trials, disparities in outcomes disappear, highlighting the importance of improving access to research opportunities.
For sponsors like you, the implication is clear: by the time recruitment begins, a substantial percentage of potentially eligible patients have already been lost. Some were never informed that a clinical trial was an option, others were overwhelmed by complex information, while many were never referred in the first place. In lung cancer, where treatment decisions move quickly, these missed opportunities directly reduce the pool of eligible patients available for enrollment. Earlier patient education, stronger physician engagement, and recruitment strategies that complement clinical care, not rely solely on it, are essential to improving enrollment outcomes.
2. The race against time: a narrow recruitment window
Alongside the shock, uncertainty, and emotional burden of a life-changing diagnosis, they are expected to navigate referrals, diagnostic tests, and treatment decisions in a matter of weeks. By the time many patients are aware that a clinical trial could be an option, their treatment pathway has already been established, leaving little opportunity to consider research participation.
The timeline is remarkably short:
- Sweden: Diagnostic testing should be completed within 4 weeks, with treatment starting within 2 weeks thereafter
- Canada: Recommends a maximum of 4 weeks from first primary care visit to diagnosis and 2 weeks to surgery
- United Kingdom: Recommends completing diagnostic tests within 2 weeks of referral, followed by rapid treatment initiation depending on therapy
A study of 275 lung cancer patients found a median of 52 days from first presentation to treatment, with patients having just 15 days between being informed of their diagnosis and starting therapy. More than one in four patients perceived delays in their care.
This compressed timeline leaves you with an exceptionally narrow recruitment window. Patient identification, physician referral, biomarker testing, pre-screening, site referral, and informed consent must all happen before treatment begins; as once standard therapy is initiated, many patients become ineligible for first-line trials. Combined with low physician referral rates, this means eligible patients are often lost before recruitment efforts even begin. For sponsors, success depends on reaching patients earlier, before treatment decisions are made, by identifying potential participants upstream and ensuring physicians and sites can act quickly when trial opportunities arise.
3. Precision medicine has fragmented recruitment
Precision medicine has transformed lung cancer treatment, fundamentally changing clinical trial recruitment. Instead of recruiting from a broad lung cancer population, you must now identify increasingly narrow groups of patients with specific molecular alterations. At the same time, I/E criteria have become more complex, layering biomarker status, disease stage, prior therapies, performance status, and other clinical characteristics on top of one another. Each additional criterion further reduces the pool of eligible patients, making recruitment viable only by finding the right patient at the right stage with the right molecular profile.
The complexity is growing:
- US Study on Metastatic non-small cell Lung Cancer: More than 80% of patients with advanced NSCLC now receive at least one biomarker test, testing rates reaching a record high in 2023 (EGFR: 88.7%, ALK:87.7%)
- Study on Advanced non-small cell Lung cancer: Biomarker testing varies by ethnicity, insurance status, smoking history, and histology, while testing rates differ substantially across countries (38% in Brazil to 91% in Taiwan)
- Even after biomarker testing, only patients who meet increasingly stringent eligibility criteria can enroll, further shrinking the recruitable population
For sponsors, this means broad awareness campaigns are no longer sufficient. Recruitment strategies must identify molecularly defined patients early, align with biomarker testing pathways, and rapidly move eligible patients through referral and screening before treatment begins. As precision medicine advances, patient recruitment must become equally precise, or sponsors risk missing an already limited pool of eligible participants.
2. Community cancer centers remain an untapped opportunity
Most cancer patients are treated in community oncology practices, yet most clinical trials remain concentrated at large academic research centers. This creates a fundamental disconnect: the majority of eligible patients receive care where research opportunities are limited or unavailable.
The gap is clear:
- Around 85% of cancer patients receive treatment in community oncology settings, yet clinical trials are accessible to only around 10% of patients
- Studies estimate that 55.6% of patients do not participate in clinical trials because no trial is available at their treating practice, while a further 21.5% are excluded by I/E criteria
- An analysis of 178 community oncology practices (568,000+ patients) found that highly research-engaged practices enrolled 3.25% of treated patients into trials, compared with just 0.27% at practices with low research engagement. Importantly, low-engagement practices cared for higher proportions of older adults, Black and Hispanic patients, uninsured patients, and those from lower socioeconomic backgrounds.
For sponsors, this represents one of the greatest opportunities to improve recruitment. Build community-oncology partnerships and decentralize pre-screening to reach the 85% of patients treated outside academic centers. Expanding recruitment beyond traditional research hospitals can increase access to larger, more diverse patient populations while reducing disparities in trial participation.
Overcoming these barriers to lung cancer patient recruitment?
The biggest misconception is that lung cancer trial recruitment is primarily a ‘patient and physician outreach’ challenge. In reality, patients and physicians are both navigating an increasingly complex landscape. Many physicians want to offer clinical trials, but they may not have the time, tools, or visibility to identify a matching study quickly enough, especially when eligibility depends on biomarker status, prior treatment history, disease stage, and rapidly evolving protocols. In lung cancer, where treatment decisions are often made within days or weeks, even small delays in matching the right patient to the right trial can mean that an opportunity is lost. As a result, patients are often not informed and guided soon enough.
The oncology landscape is changing quickly, and this requires a new model for patient recruitment. As precision medicine continues to redefine lung cancer, successful recruitment will depend on integrating biomarker testing, physician engagement, trial matching, and referral pathways into a coordinated strategy. Recruitment must evolve alongside oncology, becoming more precise, more clinically integrated, and more proactive, so that neither patients nor physicians are left to navigate trial options alone.
With our oncology recruitment solution, every patient journey begins with an experienced oncologist. By replacing automated screening and non-clinical triage with expert physician review, we facilitate access to the most appropriate care for patients, support physicians in identifying the most suitable study options for their patients, and deliver exceptional referral quality to participating sites. Rather than relying solely on patient outreach, this approach embeds recruitment within clinical care, ensuring eligible patients are identified, biomarker status is validated with the treating physician, and referrals are made before critical treatment decisions close the recruitment window.
I’ve learned that when it comes to patient recruitment, no single tactic can solve a complex enrollment challenge. The most successful recruitment strategies are those that work with existing clinical pathways rather than around them.
If I could redesign one aspect of lung cancer trials, it would be the way patients and physicians are connected to relevant study options. The greatest opportunity lies in bringing clinical trials closer to where patients are diagnosed, tested, and treated, creating a recruitment model that is faster, more precise, and better aligned with modern oncology care.