Improving Patient Centricity and Research Access

A clinical research trial can only be as strong as the participant population it’s actively reaching and serving. Additionally, the participant population should also match the population of those who need treatment. However, many research teams still struggle to improve access and retain participants in clinical trials. While there may be multiple factors involved in this challenge, location greatly affects a person’s ability to participate or not.

In fact, more than 70% of Americans live more than two hours away from a trial site. If someone were to live that far away and travel to a site on a weekly basis, that’s four hours each week they are giving up to participate – and that’s just on the commute.

Additionally, the industry is seeing a challenge in recruiting enough clinicians to participate in recruitment efforts. This is due to a high cost, low incentive ratio to participate in finding patients for trials. Since providers aren’t opting to participate in recruitment efforts, it’s increasing the challenge to find eligible patients, or even making patients aware of options available to them.

Addressing Common Challenges

The COVID-19 pandemic has given the research industry the workflows and infrastructure to address these challenges and change how research is conducted through decentralized clinical trials (DCTs). Defined as a non-traditional clinical trial model, DCTs utilize technology and processes to create options for participation beyond an exclusive physical presence at research sites. A decentralized model encompasses hybrid, agile, virtual, and remote study designs.

Shifting to a decentralized model can reap many benefits and help solve the industry’s biggest challenges. From a participation standpoint, we can remove the requirement to conduct all visits at a physical research site and allow patients from various parts of the country or world to participate. By doing so, we can allow ourselves to potentially condense the overall trial timeline, increase representation, and decrease trial costs.

Additionally, if we expand participation beyond just clinicians at sites, we can include more clinicians at various locations and organization types. This will also aid in broadening patient access by introducing clinical research to organizations normally without the option of providing a trial as a care option for their patients.

Designing an Adaptive Clinical Trial

When we move toward a decentralized model, we are moving away from limiting trials with labels. The key to success in a decentralized landscape is designing your trial to be adaptive and deployed in different ways depending on participant preference, technology, therapeutic area, and more. In this approach, patients and providers are in the middle, and surrounding them are various aspects going into a clinical trial, including:

• Home
• Site
• Care Providers
• Telemedicine
• Sponsors

Bringing all of these components together allows the patient to participate how they want to and in manners that work best for their lifestyles. By enabling the most efficient modality for that specific intervention, everyone can participate, in turn strengthening representation across the industry.

Planning Ahead

It’s paramount to appropriately design and support a DCT on both a macro- and micro-level. Thinking of what the participant could expect, how the study may unfold, and what communication methods to deploy during a trial will help ensure it runs smoothly. Similarly, it’s important for the site or provider to understand what the trial could look like at their location, as well as what it will look like for in-home activities. Outlining these details will help everyone understand what options are available to them. Outlining these details will help all study stakeholders understand what options are available for them to provide, or participate in, connecting more patients to the care they need.

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