Addressing Social Determinants of Health in Clinical Trials and Role of eClinical Systems

Social determinants of health (SDOH) encompass non-medical factors that significantly influence health outcomes. These factors include socioeconomic status, education, neighborhood and physical environment, employment, social support networks, and access to healthcare. In the realm of clinical trials, particularly in oncology and rare disease research, SDOH play a pivotal role in shaping patient participation, adherence, and overall outcomes. Integrating eClinical systems can help mitigate these disparities, enhancing the inclusivity and efficacy of clinical research. Additionally, incorporating the FDA’s perspective on these issues provides a comprehensive framework for addressing these challenges effectively.

SDOH and Their Impact on Clinical Trials

1. Socioeconomic Status:Patients with lower socioeconomic status often face financial constraints, lack of access to transportation, and limited healthcare resources, hindering their ability to participate in clinical trials.This reduces trial participation and retention rates, leading to less diverse and potentially biased study populations that do not represent the broader patient demographic.
2. Education and Health Literacy: Limited understanding of clinical trial protocols, consent forms, and the importance of clinical research can deter participation. Such misunderstandings and miscommunications often lead to lower enrollment rates and compliance issues, affecting data quality and trial outcomes.
3. Geographic Location: Patients in rural or underserved urban areas often lack access to clinical trial sites and specialized healthcare facilities. These geographic disparities result in uneven recruitment and skewed data, with urban populations typically overrepresented in studies.
4. Social Support and Networks: Lack of social support can affect a patient’s ability to manage the logistical and emotional demands of trial participation. Combined with the above factors, this leads to lower retention and higher dropout rates, compromising the integrity and statistical power of the study.
5. Access to Healthcare: Inequitable access to healthcare services, including primary care and specialist consultations, can prevent timely diagnosis and referral to clinical trials. This impacts through recruitment delays, reduced participant diversity, and potential delays in trial timelines.

The Role of eClinical Systems in Addressing SDOH

eClinical systems, encompassing electronic data capture (EDC), electronic patient-reported outcomes (ePRO), and other digital health technologies, offer powerful tools to address the challenges posed by SDOH in clinical trials.

1. Enhanced Patient Recruitment and Retention: eClinical systems can streamline recruitment processes through targeted outreach and automated eligibility screening, identifying and enrolling a more diverse patient population. With broader and more representative trial populations, these clinical trials lead to generalizable findings and improved health equity.
2. Improved Data Collection and Management: Digital platforms facilitate real-time data capture and remote monitoring, reducing the burden on patients and minimizing geographical barriers. This ensures higher quality and more comprehensive data, with fewer gaps due to patient dropouts or missed visits.
3. Increased Health Literacy and Patient Engagement: eClinical tools can provide educational resources and interactive consent processes, enhancing understanding and engagement, which eventually leads to improved patient comprehension and adherence to trial protocols, resulting in more reliable outcomes.
4. Support for Decentralized Trials: Telemedicine, mobile health apps, and wearable devices enable decentralized trial designs, allowing patients to participate from their homes. Decentralization results in greater accessibility for patients in remote or underserved areas, increasing participation rates and reducing disparities.
5. Real-Time Monitoring and Adaptive Interventions: eClinical systems support continuous monitoring of patient data, allowing for timely interventions and adaptations to the trial protocol as needed. 

SDOH significantly impacts the outcomes of clinical trials. By leveraging eClinical systems, researchers can address these disparities, enhancing recruitment, retention, and data quality. These digital tools facilitate more inclusive and efficient trials, ultimately contributing to improved patient outcomes and advancing health equity in clinical research.

eClinical systems offer a promising avenue to mitigate the challenges posed by SDOH, ensuring that clinical trials are more accessible, representative, and effective. Embracing these technologies, in line with FDA guidance, can help level the playing field, providing all patients with the opportunity to contribute to and benefit from cutting-edge medical research.

Cloudbyz eClinical is one of the fastest growing cloud based eClinical systems natively built on the Salesforce platform. Our solutions help customers of all sizes conduct clinical trials efficiently to bring life saving therapies faster to market and improve patient lives. Our eClinical platform comprises CTMS, EDC, eTMF, Safety & Pharmacovigilance and Patient Recruitment solutions.

To know more about the Cloudbyz Unified eClinical Platform contact info@cloudbyz.com