Despite being critical to the development of new cancer therapies, oncology clinical trials continue to face a major hurdle: low patient participation and enrollment. This challenge is compounded by disparities in trial access and representation, often driven by socio-economic barriers, limited availability of trial sites—particularly in underserved or rural areas—and a general lack of awareness and education about clinical research among patients. In a study evaluating the overall participation of patients in Commission of Cancer clinical trials (which represent more than 70% of all oncology-focused trials in the US), only 7.1% of patients with cancer participated in a clinical trial.¹ Of all patients with GI-related malignancies, only .2% enrolled in clinical trials.²

So why do only a fraction of patients choose to enroll in a clinical trial within one of the most prevalent therapeutic areas for disease worldwide?

In oncology clinical trials, there is often a high burden on the patient due to the nature of disease manifestation, progression, and requirements for current treatment methods. There is also a lack of sites amongst community health centers and more rural geographies, which can create additional challenges for patients who cannot travel to larger hospital or university sites, where clinical trial involvement is more prevalent.

At Milestone One, our mission is to enable research-naïve sites to get involved in clinical research, increasing access to innovative and alternative therapies for patients who would otherwise not have such access. Our transformative approach to clinical research support helps alleviate the burden for sites through administrative and operational support. We help investigators and sites bring ground-breaking treatment options to their patients and gain the experience necessary to run clinical trials, regardless of size or location.