Ark Clinical Research is set to launch a mobile unit in early 2025, marking a significant step toward decentralized clinical trials and enhanced accessibility for diverse populations. This initiative aims to bring clinical research directly to participants, particularly those in underserved communities, thereby increasing inclusivity and representativeness in trials.
Enhancing Accessibility and Diversity
Historically, clinical trials have been limited by geographic constraints, often excluding rural populations, minorities, and lower-income groups. Ark's mobile unit addresses this issue by bringing the trial to the participants. According to Samira Moran, CEO & President of Ark Clinical Research, this mobile unit is a "transformative step in improving accessibility," ensuring trials are more inclusive and representative of the patient population.
Supporting Decentralized Clinical Trials (DCTs)
The mobile unit aligns with the growing trend of decentralized clinical trials (DCTs), which allow trial-related activities to occur remotely. This includes telehealth visits, in-home visits, and mobile vans, reducing the need for participants to visit traditional medical offices or hospitals. The FDA has provided guidance on conducting DCTs, and Ark's mobile unit is a practical application of these guidelines.
The unit will facilitate key trial procedures such as blood draws, sample collections, and monitoring remotely. This is particularly beneficial for Ark’s work in metabolic, CNS, and vaccine trials, where frequent visits can be a barrier for participants. Remote visits can significantly reduce participant burden, enabling individuals to remain engaged in trials.
Strengthening Community Engagement and Data Quality
Ark’s mobile unit will enhance its commitment to local communities, building trust and engagement, especially in communities historically wary of clinical trials. The unit will conduct community outreach events, health screenings, and educational initiatives, providing an accessible entry point for individuals to learn about and participate in clinical research.
By reaching a more diverse participant base, Ark aims to improve the quality of clinical trial data. Broader representation across ethnicity, socioeconomics, and geography ensures that findings are applicable to a wider array of individuals, leading to more comprehensive and effective treatments. The mobile unit will ensure rigorous oversight and data accuracy through strict adherence to protocols and the use of digital health technologies.