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DCTs Deliver Measurable Benefits for Sponsors: Global Analysis Findings

Multiple benefits impacting trial timelines and related cost with notable reductions in protocol deviations rate, recruitment times, and first patient in.

By: Bhausaheb Patil

Head of Business Operations, Decentralized Clinical Trials, IQVIA

Prior to the pandemic, there was a limited number of industry stakeholders—pharmaceutical companies, clinical research organizations and others—who focused on decentralized trial solutions to tackle the longstanding challenge of patient engagement and retention. However, as we all experienced during the pandemic, there was a wider acceptance of Decentralized Clinical Trials (DCT) solutions among sponsors and sites to simply help with trial continuity, with encouragement of use from regulatory authorities too. The traditional clinical trial paradigm shifted fairly quickly with DCTs promising to be faster and less expensive for sponsors and sites and more engaging for patients. But are they living up to the promise of benefits, or was it a fitting solution to meet the needs of the time during the pandemic? 
 
To gauge DCTs for what they are worth to sponsors, sites and patients and how this approach compares to traditional models, IQVIA recently completed an in-depth analysis of 12 DCT studies, including sites in North America, Europe, Middle East, Africa, Latin America and Asia-Pacific, and across three therapeutic areas and seven indications. Overall, the data showed that DCTs delivered time and cost efficiencies at essentially every stage in the clinical trial process. In breaking down key findings, sponsors can better calculate the overall benefit of planning and building trials around a tailored DCT model as it applies their trial needs and their bottom lines. 

Key analysis findings  
Within the 12 phase I, II and III/IIIb DCT studies analyzed, there were 14 specific value measures used to evaluate for varying points of potential return on investment. Using these proof points, analysis findings showed multiple benefits of DCT solutions, impacting trial timelines and related cost, for sponsors to keep in mind.


There were notable reductions* in: 
       • Final protocol to first patient in (-49%) 
       • Protocol deviations rate (-54%) 
       • Recruitment time (-78%) 
       • Screen failure rates (-39%) 
       • Dropout rates (-15%) 
       • Non-enroller sites (-26%)
 
* IQVIA currently manages 300+ clinical studies using DCT methodology; however, only those DCT studies which completed 100% recruitment were selected for this analysis. While DCT methodology did help in showing better improvement versus the historical comparator, there are other factors which influenced improvement (especially start-up timelines and recruitment), e.g., different regulatory environment that was instituted by regulatory agencies and IRBs during the pandemic that helped with expedited review and decision-making processes. Therefore, the initial analysis is an indication of positive trends and impacts that a DCT model could bring and cannot be attributed solely to DCT performance. As the number of studies adopting DCT methodology continues to grow, IQVIA has now established the methodology to compare performance of ongoing DCT studies with the historical comparator and will be reviewing this on an ongoing basis to refine the metrics.

These reductions in trial timelines and related costs can have multiple layers of positive impact on how patients are initially reached and continuously engaged throughout the trial process. 
 
Faster recruitment 
Patient recruitment activities can be one of the costliest and time-intensive aspects of any trial and one of the main reasons a trial is cancelled when there is a lack of patients. With reductions in time to first patient enrolled in the trial and overall recruiting phase periods, the analysis showed how DCT approaches can help open up participation to a broader patient population regardless of location and reduce travel burdens for patients and caregivers to make it easier for them to stay engaged. 
 
Also, the analysis showed a 26 percent reduction of non-enrolling sites for the DCT studies analyzed. As sponsors spend a significant amount of time and budget on these sites in traditional studies, DCT studies can help keep costs at bay and ensure team resources are focused on enhancing efficiencies in other trial activities. 
 
Reducing deviations 
Upholding patient safety in clinical trials is a top priority for all stakeholders. While reducing protocol deviations is critical to enhancing patient safety in trials, deviations in traditional trials have steadily increased in recent years. 
 
Per the analysis, there was an average of a 54 percent reduction in deviations across various categories, including informed consent forms, study procedures, lab assessments, study visit schedules and investigational medicine product compliance.  Cutting deviation rates by more than half emphasizes how DCT technology and services can help drive improvements in patient compliance and engagement—allowing sponsors to improve trial safety and data quality. 
 
Engaged patients 
As the industry recognizes the value of the patient voice in the drug development process, it is vital to continue focusing on ways that enhance engagement and retention. Keeping patients actively participating in trials, especially in the late stage of trials where added recruitment can be very costly and create hefty delays, is critical to successful drug development. 
 
As the analysis showed DCT studies experienced lower dropout rates (15%), sponsors can see how reducing travel burdens and time spent can help patients stay involved. Integrating at-home support services such as mobile nursing and phlebotomy solutions can help with engagement without logistical concerns relative to on-site visits. Additionally, site teams leveraged DCT platforms to help patients better adhere to study requirements. This included using DCT technology to remind patients to share online diary entries, ensure they attend telehealth visits, help them complete treatment steps and more. 
 
Value of DCT planning 
Key benefits of DCT solutions can go far beyond cost. For one, there is an improvement in patient recruitment and retention as DCT trials reduce the burden on patients and thereby make patients more likely to enroll and stay engaged. This is particularly true for patients in remote areas, far from investigator sites.  In addressing long-standing barriers to participation, these solutions can also help to recruit a more ethnically and racially diverse patient base for trials to better ensure clinical research is a care option for all.
 
In order to optimize these benefits with effective DCT adoption in future trials, early planning from the beginning of the trial to integrate DCT approaches is key compared to retroactively fitting DCT elements into existing trials. Planning for DCT models from the outset, sponsors can align study goals with the appropriate DCT strategies and solutions that are more valuable to the patients, recruiters and investigators for that trial. For example, for trials where reducing the number of site visits is a key goal, the analysis showed that studies that included frequent data collection steps and use of wearables, mobile nurses and/or telehealth options allowed trial designers to reduce the number of site visits needed, making participation easier, reducing risk of attrition and increasing the speed, quality and consistency of data collection. 
 
Though every trial will require a different combination of DCT solutions and services to optimize outcomes, early planning helps to identify what components are most beneficial to ensuring an enhanced patient experience and to providing financial savings for sponsors. And, in turn, as DCTs may help reduce critical delays and costs related to dropout rates, protocol deviations and other challenges that could potentially help in having more evaluable study patients for statistical analysis at the end.  

Bhausaheb Patil has over 25 years of experience in the clinical research industry, having held various local and global roles to promote patient safety, data integrity and regulatory compliance to bring new medicines to patients faster and more safely. He has worked in a variety of functions, including clinical monitoring, clinical operations, project and resource management and risk-based monitoring approaches.

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