DCT Data: Discover Extraordinary Results and Future Trends

Introduction

The COVID-19 pandemic has significantly disrupted traditional clinical research practices, accelerating the shift towards Decentralized Clinical Trials (DCTs). DCTs utilize digital health tools to gather DCT data and monitor patient activity remotely, reducing the need for physical site visits and supporting a decentralized operational format, for example, conducting study visits at retail pharmacies.

DCTs offer several advantages, such as reducing patient travel burdens, enhancing data collection efficiency, and broadening patient recruitment by reaching more diverse populations. However, they also require robust coordination, advanced technological infrastructure, and comprehensive regulatory frameworks to ensure data integrity and patient safety ^{1 2}.​

This transformation presents new opportunities and challenges for the clinical research industry, necessitating an evaluation of organizations’ current trends and future expectations regarding DCT implementation. This study also examines the role of technology and patient-centric approaches in shaping the future of clinical trials.

Methods

A brief survey was conducted to gather data from various stakeholders involved in clinical trials, including eClinical technology vendors, Contract Research Organizations (CROs), biopharmaceutical companies, and academic institutions. The survey aimed to capture insights on:

A total of 34 respondents participated in the survey, providing a diverse perspective on the current state and future outlook of DCTs. While the sample size is low, the data provides statistically significant insights into DCT behavior in the clinical trials industry. To analyze the data, we employed chi-squared tests and Analysis of Variance (ANOVA) to determine the significance of relationships between variables such as organizational size, technology importance, and patient involvement.

Objectives

The primary objectives of the study were to:

1. Assess current trends and organizational behaviors towards DCTs.
2. Understand patient care preferences and their influence on DCT strategies.
3. Comprehend DHT utilization familiarity.
4. Explore future expectations and the role of technology in DCT implementation.

Results

The survey findings revealed several statistically significant relationships that highlight key factors influencing DCT implementation and future expectations:

Current Trends: There is a significant relationship (p ≈ 0.0475) between the size of an organization and its implementation of DCTs. Larger organizations are more likely to have adopted DCTs, indicating that resources and capabilities play a crucial role in embracing decentralized trials.

DCT Approaches: The approach to implementing DCTs varies significantly by organization size (p = 0.0263). Large organizations show a balanced split between hybrid trials (54.5%) and incorporating DCT elements into conventional studies (45.5%), indicating diverse strategies. In contrast, 100% of medium organizations preferred DCT elements in conventional studies, whereas small organizations prefer hybrid trials, reflecting 100% adoption.

Technology Interests: The type of organization is significantly related to how important they perceive technology for the future of DCTs (p ≈ 0.0307). eClinical technology vendors and CROs, in particular, view technology as critical to the success of DCTs, whereas more biopharmaceutical enterprises believe technology is important but not critical in DCTs.

Patient Involvement in DCT Design: The importance of technology is significantly linked to whether organizations believe patients should have the right to choose their trial environment (p ≈ 0.0135), and organization size (p ≈ 0.0271) also impacts patient involvement. Organizations that value technology highly are more likely to support patient-centric approaches in DCT design, and both large and small organizations value patient input in DCT design more than medium-sized companies.

Future Expectations: The perceived importance of technology is significantly related to the 3-year (p ≈ 0.0003) and 5-year (p ≈ 0.0020) outlooks for DCTs, as respondents that prioritize technology foresee robust implementation of DCTs in the near future. The charts indicate that those who believe that technology is critical in DCT implementation feel that there will be more widespread implementation of DCTs sooner (3 years) than those who feel that technology is not critical (5 years).

DHT Familiarity: Familiarity with Digital Health Technologies (DHTs) is significantly associated with involvement in DCT implementation (p = 0.0113). The chart shows that all respondents not involved in DCT implementation are not familiar with DHTs (100%). Conversely, among those involved in DCT implementation, 44.4% are very familiar with DHTs, 50% are somewhat familiar, and only 5.6% are not familiar.

Discussion

The analysis of the survey data reveals several important trends in the adoption and implementation of DCTs. These trends highlight the significant impact of organizational size, technological familiarity, and patient-centric approaches on the future of clinical trials.

Organizational Size and DCT Implementation

The survey results indicate a significant relationship between organizational size and the implementation of DCTs. Large organizations, with 64.7% having adopted DCTs, benefit from extensive resources and infrastructure that facilitate the adoption of new technologies and innovative trial designs. Similarly, medium-sized organizations, with an adoption rate of 66.7%, may also perceive the value of investing in DCTs, such as improved data quality. Small organizations, however, with a 42.9% adoption rate, tend to be restricted by their ability to fully implement and invest in DCTs as they struggle with the financial and logistical demands of such trials ³.

Approaches to DCT Implementation

The approach to implementing DCTs varies significantly by organization size. Large organizations show a balanced split, with 54.5% using hybrid trials and 45.5% incorporating DCT elements into conventional studies. This balance is possible due to their substantial resources and infrastructure, allowing them to manage both fully decentralized and hybrid trial models effectively.

Medium-sized organizations prefer fully decentralized trials, reflecting a 100% adoption rate driven by their need to maximize efficiency and scalability within resource constraints. Small organizations uniformly prefer hybrid trials, with a 100% adoption rate, as they balance limited resources with operational flexibility. Understanding these dynamics highlights why large organizations can adopt diverse strategies while medium and small organizations focus on approaches that align with their specific capacities and challenges.

Organizational Size, Patient Involvement, and the Role of Technology in DCT Design

The survey highlights that large and small organizations prioritize patient involvement in DCT design, while medium-sized organizations are less inclined to do so. Large organizations have the resources and ethos to implement comprehensive patient-centric strategies, often using patient advisory boards for direct feedback, enhancing trial relevance and patient satisfaction. Despite fewer resources, small organizations often operate in niche markets, relying heavily on direct patient feedback to refine trial designs.

In contrast, medium-sized organizations often focus more on operational efficiency and scalability, potentially overlooking the benefits of patient-centric approaches. They may face internal constraints, such as limited staff for patient engagement or competing priorities that divert attention from integrating patient feedback into DCT designs. This middle ground can create challenges in balancing resources between scaling operations and prioritizing patient involvement. According to studies, medium-sized organizations might prioritize efficiency and scalability over patient engagement due to the pressures of maintaining growth and managing resources effectively, often at the expense of more patient-centric strategies ^{4 5}.

The survey also reveals a significant relationship between the perceived importance of technology for the future of DCTs and the support for patients’ rights to choose a decentralized trial environment. Organizations that view technology as critical overwhelmingly support patient choice, with 92.6% endorsing this right. In contrast, organizations that consider technology important but not critical show less support (66.7%), and those that see minimal importance in technology do not support patient choice (100% against). This trend highlights technology’s pivotal role in shaping patient-centric approaches in clinical trials. As organizations increasingly recognize the benefits of these technologies, they are more likely to adopt flexible, patient-friendly trial designs, thus enhancing patient involvement and overall trial efficiency. The takeaway is that it is possible that more awareness about technology and DCTs could push organizations to implement DCTs and incorporate patients’ perspectives in trial designs, or those who are unfamiliar with clinical trial technology may have ossified views on clinical trial innovation concepts.

Technology’s Role in DCT Adoption

The perceived importance of technology for the future of DCTs varies significantly across different types of organizations. eClinical technology vendors and CROs view technology as critical to the success of DCTs, while biopharmaceutical companies tend to see it as important but not critical ^{6 7}. This difference is likely due to the core business focus of these organizations. Technology vendors and CROs are directly involved in developing and providing technological solutions for clinical trials, making them more aware of these tools’ potential benefits and criticality. In contrast, biopharmaceutical companies may prioritize other aspects of clinical research, such as drug development and regulatory compliance ^{8 9}.

Future Expectations for DCTs

The perceived importance of technology strongly influences expectations for DCTs in the next 3 to 5 years. Respondents who consider technology critical are significantly more optimistic about the rapid implementation of DCTs. This is evident from the 93.8% of respondents expecting widespread DCT adoption within 3 years who also view technology as crucial. In contrast, those who see technology as less important anticipate a slower adoption rate. This trend highlights that belief in the critical role of technology correlates with confidence in the near-term expansion of DCTs, suggesting that technological advancements are seen as key drivers for future growth.

Familiarity with DHTs and DCT Implementation

The data shows a stark contrast between those involved and those not involved in DCT implementation and their familiarity with DHTs. All respondents not involved in DCT implementation are unfamiliar with DHTs (100%). Conversely, among those engaged in DCT implementation, 44.4% are very familiar with DHTs, 50% are somewhat familiar, and only 5.6% are unfamiliar. This indicates that hands-on experience with DCTs greatly enhances familiarity with DHTs, highlighting the importance of practical exposure to digital health tools in driving the successful implementation of decentralized trials.

Summary

The findings from this survey emphasize the pivotal role of technology in the adoption and future outlook of DCTs. The COVID-19 pandemic has accelerated the shift towards DCTs, presenting opportunities and challenges for the clinical research industry. Larger organizations are more likely to have implemented DCTs, highlighting the importance of resources and infrastructure. The perceived importance of technology significantly influences future expectations, with organizations prioritizing technology and foreseeing robust DCT implementation. Patient-centric approaches are more prevalent in tech-savvy organizations, indicating a shift towards flexible, patient-friendly trial designs. Additionally, education in technology could be a crucial step in helping stakeholders understand the benefits of DCTs and driving broader adoption. As the industry evolves, integrating advanced technologies, enhancing patient involvement, and educating stakeholders will be essential for successful DCT implementation, leading to more efficient, accessible, and patient-centric clinical trials.

References:

1. https://acrpnet.org/2023/09/decentralized-clinical-trials-in-a-post-pandemic-era/ ↩︎
2. https://www.zs.com/insights/what-2023-fda-guidance-on-dcts-does-and-doesnt-address ↩︎
3. https://acrpnet.org/2022/06/dcts-key-considerations-for-small-to-midsized-biotechnology-and-biopharmaceutical-companies/ ↩︎
4. https://researchinvolvement.biomedcentral.com/articles/10.1186/s40900-020-00214-5 ↩︎
5. https://www.dovepress.com/patient-involvement-in-clinical-research-why-when-and-how-peer-reviewed-fulltext-article-PPA ↩︎
6. https://www.appliedclinicaltrialsonline.com/view/unlocking-the-potential-of-eclinical-technologies ↩︎
7. https://ccrps.org/clinical-research-blog/decentralized-clinical-trials-and-contract-research-organizations-in-2024 ↩︎
8. https://www.openclinica.com/blog/challenges-in-clinical-research-make-the-case-for-decentralized-clinical-trials-dcts/ ↩︎
9. https://acrpnet.org/2020/01/delving-into-econsent-industry-survey-reinforces-patient-centricity/ ↩︎