Equitable access to oncology clinical trials: harnessing technology to reduce geographic disparities

Highlights

• •Geographical disparities in clinical trials distribution impact patient access to clinical trials.
• •Trialing streamlines the search process and facilitates efficient patient referrals.
• •Trialing’s positive impact in Spain suggests that a broader applicability is feasible.

Clinical trials (CTs) play a crucial role in advancing new oncology therapies and their eventual integration into cancer care. However, despite the increasing number of available CTs, <5% of patients with cancer are included.¹ The biggest challenge in getting patients with cancer to participate in CTs is the lack of available trials at the hospital where the patient is being treated, due to the heterogeneous distribution of CTs.² Other key factors that significantly influence patient recruitment for CTs and still require substantial attention are significant social disparities and certain structural issues within health care systems, such as incompatibilities between public and private systems within the same country.

The availability of CTs varies significantly not only among countries but also within different regions in the same country, leading to unequal access to these opportunities for patients. As a result, it is crucial for physicians to stay informed about all the CTs available. Unfortunately, physicians currently lack efficient tools to search for, locate, and refer patients to these trials, and this results in inefficient searches and unreliable data on the location of where CTs are recruiting patients. Consequently, patients experience delays in receiving treatment and might even miss out on valuable opportunities.

Both the limited availability of sites offering CTs and the lack of tools providing accurate information for physicians result in patients’ access to CTs being dependent on their geographical location and the specific skills of each doctor in finding CTs, as well as their network of contacts. This highlights the need for more streamlined methods to ensure comprehensive awareness of ongoing CTs, effectively tackling these obstacles and improving patient care outcomes.

To address this challenge, a platform to search for CTs and refer patients called ‘Trialing’ (www.trialing.org) was developed in 2021 in Spain. Trialing sources its information from public databases such as ClinicalTrials.gov, as well as from collaborations with CT units updating local data. Its main goal is to provide oncologists with a reliable and up-to-date database of CTs in Spain, making it easier to refer eligible patients to active CT recruitment sites.

Trialing’s CT search engine has been developed using technology that extracts the inclusion and exclusion criteria from CTs and categorizes them based on academic standards. This enables the platform to replicate precisely the reasoning used by an oncologist when looking for a CT. For example, to see the available CTs for a patient with a metastatic lung adenocarcinoma with a sensitizing EGFR mutation who has progressed after osimertinib and has an MET amplification as the mechanism of resistance, the user would have to select: ‘Thoracic tumors’ > ‘Lung cancer’ > ‘NSCLC’ > ‘Metastatic disease’ > ‘Non-squamous’ > ‘With biomarker’ > ‘EGFR’ > ‘EGFR del19/L858R’ > ‘Second line’ > ‘EGFR and MET’. This search performed in seconds will narrow down the list to just a few available CTs for this kind of patient. A fundamental step that allows the doctor’s experience when using the platform to be unique is the data curation of CT content. This curation process is carried out in a hybrid manner, utilizing cutting-edge text analysis and processing technology, all under human supervision. With just a few clicks, the oncologist obtains a refined list of CTs in which their patient could potentially be a candidate. Thanks to an extensive network of collaborating CT units, Trialing provides information about available sites for each CT, updated on a daily basis. Lastly, Trialing incorporates a ‘last-mile’ service through which the oncologist can directly get in touch with a site to request a patient referral. All these steps enable real-time monitoring, not only of the opening and closing of trials but also of the status of all referrals. This comprehensive process, only possible thanks to the integration of human expertise in CT enrollment and data engineering, significantly streamlines the search for CTs and the process of patient referral.

Since the platform’s launch on 14 January 2022, >1500 oncologists from over 250 public and private hospitals and 100 CT units in Spain and Portugal have registered on the Trialing platform, leading to >1000 patient referrals. We have evaluated the distribution of CTs in Spain and examined the referral patterns through Trialing since the platform’s launch in January 2022 until the end of April 2023.

Among the 561 hospitals with cancer care in Spain, only 23% (131) offer CTs (Figure 1A). Of note, 2 out of 17 administrative regions in Spain account for >50% of available CTs, leaving many regions with access to only a small fraction of the trials. Approximately 69% of centers with CTs offer <20 CTs (small centers), 21% offer between 21 and 75 CTs (medium centers), 8% offer between 76 and 150 CTs (large centers), and only 2% offer >150 CTs (giant centers; Figure 1A). All large and giant centers, 75% of medium centers, and 27% of small centers received referral requests through the platform. Interestingly, not only the small and medium centers referred patients elsewhere, but also 83% of large centers and 60% of giant centers actively request referrals to other sites through Trialing’s technology (Figure 1A). Patients have not only been referred to nearby hospitals but also to distant regions within Spain and even between hospitals in Portugal and Spain (Figure 1B). Furthermore, the platform received referral requests for CTs involving patients with rare diseases, including sarcoma and mesothelioma (19 and 32 referrals, respectively). In addition, there were referrals for CTs focusing on drugs targeting rare mutations such as FGFR, PIKCA, ALK, RET, and ROS1 (with 10, 5, 5, 5, and 3 referrals, respectively). Trialing allowed the oncologist to find a CT for a specific patient in <30 s and it facilitated contacting any available site in <24 h.

Figure 1.

(A) Distribution of clinical trial activity across different-sized centers in Spain, highlighting the predominant use of Trialing for patient referral requests in every categories. (B) Overview of patient referral patterns via Trialing, showing the movement of patients between distant centers.

Currently, there is a notable concentration of CTs centered around specific tumor types, with lung cancer, breast cancer, and colorectal cancer taking the lead (comprising 28%, 16%, and 12% of the total pool of available CTs, respectively). This distribution corresponds closely to the patterns of demand for inclusion in CTs at distant centers, as these particular conditions account for the majority of referral requests made through the platform.

In conclusion, the implications drawn from these findings highlight an evident concentration of CTs within specific geographic areas. These observations not only shed light on this geographic disparity but also underscore the pressing necessity to enhance and ensure equitable access to CT for all patients, regardless of their location or circumstances. By offering a user-friendly platform with real-time and accurate information that connects oncologists and patients with relevant CTs, Trialing demonstrates its potential to alleviate geographical disparities and create more equitable health care opportunities for patients with cancer. Its positive impact and successful adoption in the Spanish oncology community suggest its potential applicability in other countries facing similar challenges.