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Distance a Key Barrier to Clinical Trial Access: Decentralized and Hybrid Trials

By July 1, 2024No Comments

Access to clinical trials allows patients to receive innovative treatments that are not yet available on the market. However, patients face numerous obstacles when attempting to participate in clinical trials, one of the main ones being travel distance.

Many clinical trials are conducted in major metropolitan areas or specialized research institutions, which may be located far from where patients live. This geographic barrier can make it difficult for patients, especially those in rural or underserved areas, to access trial sites. Long travel distances can be burdensome and costly, requiring significant time off work, transportation expenses, and logistical arrangements for ongoing care during the trial period. For some patients, especially those with mobility issues or financial constraints, the necessity of travelling to participate in a trial can be a prohibitive factor.

Distance as an Obstacle to Clinical Trial Access: Who Is Affected and Why It Matters

A recent report by the Milken Institute identifies US counties located more than 60 miles away from a county that has hosted a Phase 2 or 3 clinical trial for a specific disease over the past five years.

The report highlights the following:

  • Clinical trials predominate in major metropolitan areas and their outlying suburbs. Coastal counties are more likely to host a trial than those in the country’s interior, a pattern that matches with population density.
  • Counties more than 60 miles from a clinical trial tend to have lower incomes and education levels, less access to the internet, and a higher rate of disability than closer counties.
  • Specific types of places tend to be far from clinical trials regardless of the disease being studied. Affluent suburbs, college towns, and urban cores are rarely over 60 miles from a trial, whereas agricultural counties (particularly in the Great Plains region) and American Indian Reservations are disproportionately likely to be over 60 miles from a trial.
  • Clinical trials are not always close to high-prevalence populations. There are “high-prevalence remote counties” that contain populations in the top quarter of disease prevalence and are over 60 miles from the nearest trial county. These locations are high-priority places for the expansion of clinical trials.

The Solution: Decentralized and Hybrid Trials

Decentralized and hybrid clinical trials can significantly address the accessibility issues highlighted in the report by the Milken Institute. By minimizing the need for physical travel to trial sites, decentralized trials can bridge the gap between rural, underserved, and high-prevalence remote counties and cutting-edge medical research. Participants from areas more than 60 miles away from traditional trial sites can engage in studies through telemedicine, home health visits, and digital health platforms. This can democratize access to clinical trials, ensuring that geographical barriers no longer prevent patients from benefiting from new treatments.

Decentralized Trials

Decentralized trials can improve inclusivity by reaching populations that typically have lower incomes, less education, and limited internet access. By deploying mobile clinics, satellite trial sites, and community health workers, trials can be conducted in diverse settings that are more accessible to these communities. This approach can also foster trust and engagement among populations that have historically been underrepresented in clinical research, leading to more diverse and representative trial populations. The inclusion of a broader demographic spectrum can enhance the validity and generalizability of trial outcomes.

Hybrid Trials

Hybrid clinical trials offer a flexible model that can combine the benefits of both traditional and decentralized approaches. For instance, initial assessments and complex procedures can be conducted at central sites, while routine follow-ups and monitoring can be performed remotely. This flexibility can reduce the logistical and financial burdens on participants, making it easier for those from agricultural counties and American Indian Reservations to partake in clinical research. By incorporating both in-person and remote elements, hybrid trials can ensure rigorous data collection while accommodating the needs and constraints of diverse populations.

In addition, decentralized and hybrid trials can help ensure that clinical research is conducted closer to high-prevalence populations. By utilizing local healthcare providers and facilities, trials can be set up in regions with high disease prevalence but limited access to research sites. This localized approach not only makes participation more convenient for patients but also aligns trial locations with areas of greatest need. Consequently, this can enhance the relevance of clinical research and expedite the development of treatments for diseases that disproportionately affect remote and underserved communities.

Overall, decentralized and hybrid clinical trials represent a transformative approach to clinical research, one that prioritizes patient convenience, inclusivity, and access. By overcoming the traditional barriers of travel distance and site accessibility, these models can ensure that more patients, regardless of their location or socio-economic status, have the opportunity to benefit from the latest advancements in medical science.

 

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