Patient recruitment remains one of the most persistent challenges in the clinical trial sector, compounded by the growing number of trials and increasingly complex protocols. Identifying eligible participants has become particularly difficult for conditions, such as inflammatory bowel disease (IBD), with high competition among marketed therapies and robust pipelines. To address this, the PPDTN clinical research business of Thermo Fisher Scientific has expanded its patient locating capabilities to power recruitment strategies. Through its partnership with Virgo, which leverages AI-driven technology to analyze real-time endoscopy data, we are advancing the recruitment process and enhancing clinical trial efficiency.
Breaking Barriers in Patient Recruitment
Over the past decade, the pharmaceutical development pipeline has grown exponentially, resulting in a dramatic surge in the number of clinical trials. This rapid expansion has intensified the demand for clinical trial participants. The situation is further complicated by the fact that many of these trials target rare diseases with small patient populations.
Study protocols have become increasingly complex, driven by innovative therapies requiring intricate trial designs and compliance with diverse regulatory requirements. According to the 2024 Pulse Survey, these factors are among the top drivers of rising clinical trial costs, alongside the need to collect more data and insights during studies. The demand for hard-to-find patient populations further amplifies this complexity, with trials targeting rare diseases or requiring diverse demographics encountering significant hurdles.
Simultaneously, investigator sites face mounting resource and staffing constraints, a challenge reported by 19% of small to mid-size biopharma companies. Larger organizations also cite pressures to meet regulatory demands and shortened timelines. These resource challenges are compounded by a highly competitive landscape: as the number of trials increases, recruitment becomes more difficult, particularly for diseases with robust pipelines like oncology and inflammatory bowel disease (IBD), where patient populations are stretched thin across multiple trials.
As a result, identifying patients who meet study criteria and are willing to participate in clinical trials has become increasingly difficult — even for trials addressing more common conditions like IBD. For example, between 1998 and 2018, the average recruitment rate for moderate-to-severe ulcerative colitis trials dropped from 0.32 to 0.13 patients per site per month, while recruitment for moderate-to-severe Crohn’s disease decreased from 0.65 to 0.10 patients per site per month.1 In the United States, where recruitment is especially challenging, randomized controlled trials for IBD saw declining participation rates between 2011 and 2018, even as the number of available trials increased.2 Younger patients, those in community health care settings, and individuals with milder disease were particularly underrepresented.
The consequences are clear: enrollment periods are stretching longer, delaying the progression of critical studies. Without innovative approaches, these trends risk hindering the development of new therapies for a wide range of conditions.
The patient journey begins well before consent — it starts at diagnosis, or even earlier. To recruit patients effectively, engagement must begin at this foundational stage.
Harnessing Digital Data to Transform Patient Recruitment
To tackle the pressing challenge of patient recruitment, we launched the patient first digital solutions strategy, designed to address patient needs across the full spectrum of research. This comprehensive program encompasses digitalization, decentralization, consultancy services, diversity initiatives, and recruitment and engagement solutions. We have streamlined and consolidated our capabilities to deliver a seamless, patient-first clinical trial experience, supporting participants every step of the way—from their initial interaction to the final visit.
The rapid acceleration in the generation, collection, and accessibility of digital data presents a significant opportunity for healthcare and research to converge. By making clinical research more accessible, we help patients connect with trials that meet their needs, reducing barriers and enhancing the overall experience for participants.
With a proactive approach to integrating clinical trials into standard care, the recruitment process can be transformed. Historically, patient identification has been fragmented, relying on a mixture of site-initiated and centrally led outreach campaigns. Leveraging digital data effectively enables a shift from reactive to proactive recruitment strategies. For example, by analyzing patient data in real time, organizations can match the right patient to the right trial at the right time.
Furthermore, successful solutions must support both patients and health care practitioners (HCPs) without adding to their workloads. Many HCPs are already overburdened, and expecting them to take on additional recruitment responsibilities can be a challenge. Instead, digital tools like AI-powered algorithms can automate patient identification, allowing HCPs to focus on care delivery while enhancing patient access to research opportunities.
Bringing Recruitment to the Point of Diagnosis
For many patients, learning about clinical trials can be a complex and fragmented experience, particularly if their physician is not already involved in research. By integrating recruitment efforts within standard healthcare practices — especially at the point of diagnosis — both awareness and access to clinical trials can be significantly improved.
One approach can be a hub-and-spoke site solution. For large health systems, this is accomplished by ensuring robust data capture across the system — primary hospitals, community hospitals, and outpatient centers. Solutions like Virgo automate that data capture and analysis, directly bringing the trial to the patient’s site of care. Alternatively, data can be syndicated across smaller health care providers and centralized to a research clinic to create novel research pathways.
These streamlined networks address challenges in patient engagement while maximizing resources and reducing the logistical burden on trial sites.
Overcoming Recruitment Barriers in Gastrointestinal Trials
In the gastrointestinal (GI) disease space, endoscopy is integral to the standard of care. However, if patients are not introduced to clinical research during their initial procedure, participation often requires a repeat procedure. In a 2019 survey study conducted by the Crohn’s and Colitis Foundation,3 patients expressed negative sentiment around trial participation due to the need for multiple colonoscopies. Reducing procedural burden makes trial participation more appealing to patients. Engaging patients immediately following colonoscopy also ensures they are offered research as an option prior to beginning a course of treatment that would otherwise make them ineligible for participation.
Achieving this level of access is not without challenges. In the United States particularly, critical clinical data are frequently missing. For example, endoscopy videos are a rich source of information, but the specific scoring metrics required for trials are often neither calculated nor recorded in medical records.
A promising solution lies in accessing the source data itself — in this case, the endoscopy videos. Leveraging artificial intelligence (AI) algorithms, it is possible to analyze these videos in real time during the procedure to determine a patient’s potential eligibility for a clinical trial. This approach eliminates the need for physicians unfamiliar with clinical trial scoring conventions to calculate scores manually. Moreover, both the physician and the research team receive immediate notifications when a potentially eligible candidate is identified, streamlining recruitment efforts and reducing barriers to participation.
Innovating Endoscopy to Revolutionize Clinical Trial Recruitment
Globally, countless endoscopic medical procedures are performed annually, yet most of the video data from these procedures are not saved. Typically, only a few still images — often low quality and unrepresentative of the entire procedure — are entered into a patient’s medical record. Recording the full procedure offers significantly better documentation, creating a valuable resource for AI and big data analytics to support clinical insights and research applications.
Virgo launched its automated video capture system and has since captured over 1.7 million procedures, building the largest data set of endoscopy videos in the world.
By analyzing patients’ clinical endoscopic presentations, Virgo’s system identifies potentially trial-eligible patients at the optimal time for enrollment: standard-of-care endoscopy. The company has deployed its technology at 150 brick-and-mortar locations across 70 unique health systems, including academic medical centers, large private practices, and integrated health systems, with plans to expand into smaller outpatient endoscopy centers.
Targeting IBD to revolutionize Point-of-Diagnosis Recruitment
IBD is a significant focus for pharmaceutical investment, with a robust pipeline of new drug candidates and numerous approved products, resulting in a high volume of active trials spanning phase I to phase IV. These studies often involve complex protocols and frequent endoscopy evaluations, requiring meticulous coordination of patient care.
Despite the high level of activity, recruitment for IBD trials remains particularly challenging. Globally, the average recruitment rate for these studies is less than one patient per site per year, with rates in the United States even lower. These barriers highlight the urgent need for innovative solutions to improve recruitment outcomes in this space.
Addressing these challenges requires a multi-faceted approach. Technology and AI play a critical role in alleviating workflow burdens on trial sites, while coordinated efforts to engage patients at the point of diagnosis ensure timely and appropriate referrals into research opportunities.
Advancing Recruitment with Artificial Intelligence
AI plays a pivotal role, offering an opportunity to automate endoscopy video analysis, a task that typically requires significant time and effort from physicians. In the context of ulcerative colitis and Crohn’s disease — two key indications under IBD umbrella — endoscopic scoring is essential for clinical trials but rarely used in standard practice. Virgo’s proprietary AI model, AutoIBD, automates endoscopic analysis to identify videos of patients who may potentially be eligible for clinical trial inclusion by recruitment groups like our patient first recruitment and engagement group.
Looking ahead, Virgo is developing an advanced AI foundation model for endoscopy that promises to deliver even deeper insights. This cutting-edge system aims to analyze colonoscopy results to predict a patient’s age, sex, ethnicity, comorbidities, and, most critically, their likelihood of responding to specific treatments. These capabilities will enable more precise trial matching, ensuring patients are placed in studies most suited to their profiles. Over time, such advancements could even reduce the number of participants required for a given trial, accelerating drug development timelines.
Patient First Recruitment are also harnessing the power of AI to transform patient recruitment. With a research registry of approximately 18 million patients, AI tools are used to identify potential matches between patients and clinical trials. Another AI program evaluates both internal patient data and external healthcare records to calculate the likelihood that a patient will consent to participate, optimizing the recruitment funnel by focusing on the most probable candidates.
In addition, we offer a patient community platform, currently home to approximately 2 million members and growing rapidly. This platform fosters connections among patients with similar conditions while generating consented data that bridge healthcare and research. By leveraging these data, AI provides valuable insights that improve recruitment success.
The Critical Role of Rapid Response in Recruitment
Studies consistently demonstrate that patients prefer swift follow-up regarding clinical trial opportunities after receiving a diagnosis. This preference is particularly evident in the GI space, where many physicians use endoscopy video data to explain findings to their patients. This immediate communication fosters trust and understanding, making it an opportune moment to discuss research opportunities. Engaging patients about clinical trials during this critical touchpoint significantly increases their likelihood of participation.
For IBD patients, timely follow-up is even more crucial. Many undergo colonoscopies during disease flares while actively seeking treatment options. Delays in outreach can result in patients pursuing alternative therapies that disqualify them from trial participation, underscoring the need for rapid intervention in the recruitment process.
However, reaching patients promptly often proves challenging, as many diagnoses for IBD, cancer, and other conditions occur in community healthcare settings where physicians are not directly involved in research. Establishing a direct pipeline to diagnostic data is vital for ensuring that patients are approached at the right time, maximizing recruitment potential and enabling access to innovative treatment options.
Revolutionizing Recruitment across Therapeutic Areas
By capturing clinically relevant data across various diseases, AI presents new opportunities to streamline clinical trial recruitment at the point of diagnosis across a broad spectrum of GI disorders.
Beyond the GI space, the capability can expand into additional clinical specialties, such as bronchoscopy procedures, offering the potential to enhance recruitment for trials targeting lung diseases like chronic obstructive pulmonary disease (COPD), interstitial lung disease, and non-small cell lung cancer. Future applications in urology, gynecology, and nephrology are also being explored as the scope of data collection broadens.
Wherever relevant digital data is being generated, organizations like ours can leverage them to enable more efficient clinical trials, from patient recruitment to final results reporting. The benefits extend across the ecosystem, improving outcomes for patients, physicians, investigator sites, and study sponsors alike. This opportunity is particularly valuable when diagnostic data are already being collected, as it allows for immediate integration into the recruitment and enrollment process.
Significant progress is anticipated in using AI and endoscopy technologies within clinical trials. For instance, colonoscopy data show potential as a predictive digital biomarker for a range of GI and non-GI conditions, laying the foundation for integrating research opportunities at the point of diagnosis.
As these technologies evolve, they promise to reshape the clinical trial landscape, making research more inclusive, efficient, and accessible. By leveraging these advancements, we can bridge the gap between diagnosis and participation, ensuring that patients have timely access to innovative treatments while empowering physicians and researchers to deliver better outcomes. This holistic approach underscores the transformative potential of data-driven insights in improving healthcare and advancing medical innovation.
References
1. Johnson, Cole, et al. “Trends and Characteristics of Clinical Trials Participation for Inflammatory Bowel Disease in the United States: A Report From IBD Partners.” Crohn’s & Colitis 360. 15 Apr. 2020.
2. Kosov, Maxim. “Top 4 Sponsor Challenges in IBD Patient Enrollment.” PSI. n.d.
3. Ehrlich, Orna. “Crohn’s disease and ulcerative colitis patient perspectives on clinical trials and participation.” medRxiv.