1 May 2025
Improving direct patient access to clinical trials
Clinical trials are pivotal in the drug discovery and development cycle. They enhance patient access to safe and effective treatments to improve their overall quality of life and, in some cases, slow disease progression by interfering with faulty mechanisms. Hence, a key barrier in healthcare is the low patient recruitment (and high dropout) rates in clinical settings.
Who is responsible for recruiting patients?
Despite the importance of patient involvement, it is unclear who is responsible for recruiting patients in clinical trials. In accordance with the Declaration of Helsinki (a set of ethical guidelines for researchers to follow when conducting medical research involving human participants), this role should lie with healthcare professionals (HCPs) to ensure that patients are adequately informed about the potential benefits and risks associated with clinical trials. (1) While HCPs are critical in informing patients about trials and facilitating recruitment, seen as trusted sources in the eyes of patients, they are often under significant time constraints and do not receive compensation for these services. As a result, evidence indicates that HCPs refer an inadequate number of patients to clinical trials annually to ensure robust patient cohorts. (2)
Patient advocacy groups (PAGs) (organisations that support individuals living with disease by providing information, resources, and a voice for patients) offer an alternative route to educate patients about relevant clinical trials. This has been effectively demonstrated by the PACER programme in India, comprising online courses, workshops, and focus group discussions. As a result, participants' awareness of clinical research increased, addressing misconceptions and building trust. (3) However, there is a lack of standardised protocols for involving PAGs and other patient organisations in clinical trial awareness and accessibility.
Can patients recruit themselves?
Existing platforms for patients to find suitable clinical trials are often limited, with many offering complex or inaccessible information. As patient-centred care grows, there is a demand for better tools that empower patients to take control of their health and seek out clinical trials directly.
Patients can search online databases to identify clinical trials that match their preferences and needs. ClinicalTrials.gov is a well-known platform where patients can refine their search using filters such as disease and location. ClinicalTrials.gov provides a comprehensive list of trials spanning all therapy domains, treatments, and locations worldwide, as well as up-to-date and transparent information to help patients make informed decisions. Despite this, ClinicalTrials.gov is designed for researchers, which makes it less accessible for patients. For example, when searching for breast cancer studies in Edinburgh, the first trial that appears is ‘Axillary Management in Breast Cancer Patients with Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy (ATNEC)’. This language is highly technical and can be overwhelming, requiring considerable effort from non-experts to understand. Further, this database primarily serves as a self-navigating tool (e.g., there is no live chat function to assist patients) for trial enrollment. (4)
Fortunately, user-friendly alternatives are available to support patients embarking on their clinical trial journey. Antidote is one example of a patient-focused trial search platform, asking patients simple questions to determine appropriate options, providing easy-to-understand trial descriptions, and offering a messaging service. (5) Ancora.ai offers another digital clinical trial navigation tool for patients, connecting people living with cancer to novel therapeutics. (6) Similarly, many PAG websites offer personalised clinical trial matching tools, such as BreatCancerTrials.org, bridging patient-centred care and clinical research with artificial intelligence (AI). (7)
How can we improve direct patient access to trials?
Although some patient-friendly databases and AI-driven trial matching have been established, industry professionals must leverage these platforms and direct patients to them to improve clinical trial access and participation.
Ansah and colleagues (2024) demonstrate the value of the “Speaking Book”—an interactive, audio-visual tool that educates patients about clinical trial participation in their native language—for improving patient understanding and awareness of clinical trials, particularly in underserved communities with low literacy levels. (8) Likewise, with guidance from a patient navigator, bilingual educational videos involving cancer patients sharing their experiences have been shown to increase clinical trial participation among underrepresented populations. (9) Leveraging these strategies ensures equitable access to clinical trials and fosters a diverse and inclusive clinical landscape.
Digital outreach—circulating upcoming clinical trials on social media—has also proven effective in increasing patient awareness and access to clinical trials. One example is a 2019 digital public awareness campaign that used targeted Facebook adverts to promote awareness of the ResearchMatch Trials Today clinical trial search tool among patients in the United States. This resulted in higher engagement rates at a low cost. (10)
With the growing digital space, disseminating lay materials across diverse patient populations is becoming easier. This shift is critical to empower patients with the resources and knowledge they need to actively engage in their care. At Syntheis, we recognise the importance of user-friendly platforms that help patients understand the true experience of participating in a clinical trial and simplify the navigation process. Contact us at info@synthesishealth.co.uk to learn how we can help you strengthen patient partnerships and promote awareness of clinical research engagement strategies to improve patient recruitment and retention.
References
https://www.wma.net/policies-post/wma-declaration-of-helsinki/
Getz KA. Examining and Enabling the Role of Health Care Providers as Patient Engagement Facilitators in Clinical Trials. Clin Ther. 2017;39(11):2203-2213. doi:10.1016/j.clinthera.2017.09.014
Bagai P, Sharma P, Ansari A, et al. Patient Advocates for Clinical Research (PACER): A Step Toward Ethical, Relevant, and Truly Participatory Clinical Research in India. Cureus. 2024;16(4):e58454. Published 2024 Apr 17. doi:10.7759/cureus.58454
https://www.breastcancertrials.org/BCTIncludes/WhyParticipate/WhyClinicalTrialsAreImportant.html
Ansah P, Parmar B, Onyango D, et al. Prospective, Multicenter Study to Assess the Effect of the Speaking Book on Patients' Understanding of Clinical Research Knowledge: The SOUND Study. Blood. 2024;144 (Supplement 1):2441. doi:10.1182/blood-2024-206983
Chalela P, Cortez V, Flores A, et al. Abstract A064: My Choices: A multilevel, multicomponent intervention to improve informed decision-making about clinical trial participation among cancer patients. Cancer Epidemiol Biomarkers Prev. 2023;32 (12_Supplement):A064. doi:10.1158/1538-7755.DISP23-A064
Jerome RN, Dunkel L, Kennedy N, et al. To end disease tomorrow, begin with trials today: Digital strategies for increased awareness of a clinical trials finder. J Clin Transl Sci. 2019;3(4):190-198. Published 2019 Aug 20. doi:10.1017/cts.2019.404