Introduction: Clinical trials are essential to the advancement of clinical therapies that improve the outcomes of people with cancer. However, enrollment in clinical trials remains a challenge. The Clinical Trial Navigator [CTN] Program was designed to address the current gap in the cancer care journey by assisting with the clinical trials search process. Methods: Between March 2019 and July 2024, applicants of the CTN program included people with cancer, their family members, and/or their care team. Applicants entered the CTN program through a REDCap® survey that collected the patient’s medical history. A final curated list of potential clinical trials was provided to the applicant. Metrics of success included clinical trial referral and enrollment, and we examined the factors that impacted these outcomes. Results: A total of 445 people with cancer applied to the CTN program during the study. Of the 262 patients with referral and enrollment information, a trial referral occurred in 27.5% [n = 72]. Of the 72 patients who were referred to a clinical trial, 13 [18.1%] were enrolled, 9 [12.5%] are pending enrollment, and 50 [69.4%] were not enrolled. We identified a potential trial for 88% of applicants, with a median of one potential trial per patient. Physicians were highly involved as applicants. Interpretation: The CTN program is successful in searching for clinical trials for people with cancer. Ongoing implementation into other Canadian sites, assessments of patient-reported outcomes, website and social media campaigns, and research into the factors that impact referral and enrollment are underway.
Background: Clinical trials play a critical role in providing patients with access to novel treatments and therapies. However, limitations in clinical trial search engines impede healthcare professionals and patients from accessing the most suitable clinical trials. This study aimed to address this issue by conducting a critical analysis of several prominent clinical trial search websites, including ClinicalTrials.gov, Canadian Cancer Trials, Clinical Trials Ontario, Canadian Cancer Clinical Trials Network, and Q-CROC. Methods: To identify areas for improvement, three skilled clinical trials navigators independently curated clinical trial searches for 18 cancer patients over a 2-month period. After verifying patients’ eligibility for enrollment in clinical trials, the navigators documented their search outcomes and identified several limitations in the current search engines. Results: Careful curation of clinical trials for 18 patients revealed 247 trials. However, 140 eligible trials out of 247 (57% with 95% binomial confidence interval [50%, 63%]) were found only on alternative websites yet not discoverable on the initial ClinicalTrials.gov searches, even though they were listed on ClinicalTrials.gov. Our study revealed multiple deficiencies in available clinical trials search engines. Lack of reliability was repeatedly identified in all search engines. Discussion: This study highlights that the current clinical trial search system needs improvement to enhance patient outcomes. It needs to be highlighted that these searches were performed by trained and dedicated clinical trials navigators. The challenges facing patients and health care professionals in navigating would be much greater. The findings from this study can serve as a foundation for the development of enhanced search engines with improved functionality, which will enable healthcare professionals and patients to find and access the most suitable clinical trials with greater ease and accuracy.
Patient navigation is a promising intervention to address barriers and improve access to cancer clinical trials. Although navigation has been widely studied across the cancer continuum, its role in facilitating clinical trial participation has not been systematically evaluated. This scoping review aims to identify, characterize, and synthesize evidence on patient navigation interventions designed to increase access to cancer clinical trials. Nine databases were searched for English peer-reviewed articles from inception through 5 March 2025. Two independent researchers screened titles, abstracts, and full texts and extracted data using standardized forms. The results were interpreted using descriptive statistics and collated using predetermined conceptual frameworks. Of 10,238 citations identified, 23 studies met inclusion criteria. All were conducted in North America, and five (21.7%) were randomized controlled trials. Thirteen studies (56.5%) evaluated enrollment outcomes, with mixed results. One randomized trial and two observational studies found no significant effect, while three observational studies and seven single-arm reports suggested improved enrollment. Navigation interventions most commonly included education/information provision (100%), care coordination (60.9%), and empowerment (47.8%). Navigators were primarily lay navigators (73.9%), often selected for community or lived experience; training varied widely, and only two programs reported certification. Fifteen studies (65.2%) targeted equity-deserving groups, most frequently racial and ethnic minorities, with reports of increased representation in trial enrollment. Patient navigation shows promise in improving access to cancer clinical trials, particularly for equity-deserving populations, but current evidence is limited, heterogeneous, and largely observational. Standardized definitions, rigorous trial designs, and reporting of navigator training and outcomes are needed to clarify effectiveness.