Winston Churchill once famously said; “Healthy citizens are the greatest asset any country can have.” The importance of a healthy population is why we see such empahsis, both political and personal, on protecting access to medical and healthcare services. And why, in times of conflict, actions that undermine the work and safety of healthcare structures and staff, attract such universal concern and condemnation.
Healthcare is more than a service, it’s a fundamental human right!
And if we care about health in a holistic fashion we need to think about access from root to branch. At ClinicalTrials.EU we believe that access to healthcare should also mean the opportunity to find, research and explore the opportunities presented by new, potentially life-saving treatments that may not yet be available on the open market.
However, at the moment, access to clinical trials across the EU is fragmented, with significant disparities based on geography, socioeconomic status, and other factors. This ultimately leads to a system that is unfair, favouring those in more developed societies and wealthier backgrounds who have the time and resources to seek out new and innovative treatments.
The Current Landscape for Clinical Trials in Europe
Clinical trials are not just a beacon of hope for patients but a cornerstone of medical research, providing the data needed to bring new treatments to market and improve patient outcomes.
As of late 2023, the European Union Clinical Trials Register lists more than 43,000 trials in total and approximately 14,474 live trials, with a significant portion involving pediatric participants. These trials cover a broad spectrum of therapeutic areas, including oncology, cardiology, and rare diseases, reflecting the diversity and scope of medical research conducted across Europe.
Unfortunately, the current clinical trials ecosystem sees significant challenges for patients trying to access them. For many patients, particularly those living in rural or underserved areas, the opportunity to participate in a clinical trial is limited. This disparity is especially pronounced for patients with rare diseases, who often have few options outside of experimental treatments offered through clinical trials.
One of the major issues is that many potential patients just don’t know these trials exist or how to be recruited onto the right ones. There are a number of platforms with information on ongoing trials such as the Clinical Trials Information System (CTIS). However these are often clinician-facing, rather than patient-facing with technical details that are difficult for a layman patient or caregiver to understand if it is relevant for their condition. This barrier prevents many patients from participating in trials that could benefit them.
The Complexities of Participation
Once you are over the information barrier, you may well then encounter the logistical barriers. Trial sites are often concentrated in major cities, where clinicians or research sites are located, making it difficult for patients in rural or remote areas to participate. This urban-centric model not only limits access but also exacerbates existing healthcare disparities. Patients in these areas may face long travel distances, which can be particularly challenging for those with limited mobility or those suffering from severe illnesses.
The design of clinical trial protocols is also problematic as they often exclude patients who do not meet a very specific criteria. For example, patients with multiple comorbidities or those who are older and more frail are frequently excluded from trials due to concerns about data variability or adverse events. This rigidity in trial design can prevent large segments of the population from accessing potentially life-saving treatments.
Democratising Access to Clinical Trials
Addressing the opportunity gap for patients and researchers requires democratising access to clinical trials in its nature. Greater visibility, comprehensive but simpler communication and a more flexible approach are all required to connect patients with complex or rare conditions with researchers needing a large, qualified pool of participants.
This could be created through:
Increased Awareness and Visibility
This can be achieved through targeted public health campaigns, partnerships with patient advocacy groups, and improved use of social media and other digital platforms. For example, studies have shown that more than 85% of EU citizens regularly use the internet, with health-related information being one of the most searched topics. By making information about clinical trials more accessible online, we can reach a broader audience and increase participation rates.
Simplifying Language and Communication
To make clinical trials more accessible, it is essential to simplify the language used to describe them. This involves not only translating technical jargon into plain language but also ensuring that information is available in multiple languages. Tools like interactive websites, explainer videos, and patient-centered communication strategies can help bridge the gap between healthcare professionals and potential participants.
Decentralising Clinical Trials
Traditionally, clinical trials have been centralized in major urban centers, making them inaccessible to those living in remote areas. To democratise access to clinical trials, we need to shift towards a more decentralised model, where trials are conducted closer to where patients live. Decentralised clinical trials (DCTs), which leverage digital technologies to allow patients to participate from their own homes, are an effective way to overcome geographical barriers and make trials more accessible.
Fostering Patient-Centricity
Patient-centric clinical trials focus on the needs and preferences of participants. This approach involves engaging patients in the design and implementation of trials, ensuring that their voices are heard and their needs are met. By adopting a patient-centric approach, clinical trials can become more responsive to the needs of participants and more effective in recruiting and retaining patients.
Leveraging EU Initiatives
The EU has launched several initiatives aimed at improving access to clinical trials. For example, the EU-X-CT initiative (https://eu-x-ct.eu/) focuses on facilitating cross-border participation in clinical trials, while one of the HORIZON projects aims to promote equitable clinical research across Europe. These initiatives represent important steps towards democratising access to clinical trials and ensuring that all EU citizens can benefit from the latest medical advancements.
Enhanced Access to benefit all
By improving access to clinical trials, we can ensure that patients across Europe, regardless of their location, socioeconomic status, or medical condition, have the opportunity to participate in scientific research and benefit from new treatments. This is vital as in order to advance medical science and understanding we need a wider pool of appropriate patients to take part in research. Only by democratising access to connect patients to clinical trials researchers will we be able to accelerate the development and production of potentially life-saving new treatments.
By Lukasz Izbicki, CEO, ClinicalTrials.EU