Technological innovation has enabled the large-scale adoption of the decentralized and hybrid clinical trial model (DCT). DCT makes it easier for more participants to participate in clinical trials, allows remote data collection and greatly reduces or completely eliminates the need for in-person clinical visits.
In addition, a clinical trial model that reduces the need for frequent face-to-face visits enables sponsors to expand their potential participant groups while reducing participants’ travel burden.
Nevertheless, people still think that this kind of expansion will make the test more expensive. The fact is that the more research leaders use the DCT method to expand access to eligible patients and introduce new efficiencies in the research, the more costs they can eliminate, thereby reducing overall research costs. Here are five ways the DCT method can help save money.
- Reduce costs through better recruitment
Poor recruitment of participants is a common and costly inefficiency in clinical trials. Generally speaking, participant recruitment accounts for 40% of a given clinical research budget. In order to reduce costs, many research leaders find themselves under pressure to shorten recruitment time. Although this may make sense, it is theoretically difficult to complete in traditional design research. This is because these studies are limited to recruiting participants who live within a reasonable range of the research center. The term “reasonable” is subjective because more than 70% of clinical trial participants live two or more hours away from the research center.
On average, traditionally designed clinical trials have experienced a 30% participant turnover rate. Shortening the time actually locks the research into the less than ideal enrollment rate and subsequent poor adherence to the care plan and high dropout rates—increasing costs.
Sponsors have the opportunity to develop research designs that make research participation easier and easier, rather than focusing on a shorter recruitment timeline itself. DCT provides an opportunity to make it easier for most participants to participate in clinical research, and it makes it easier for potential participants who live further away from the research center to participate in research. Without having to perform all evaluations at the clinical trial site, sponsors can greatly expand the geographic area where trials can be successfully recruited. Opening up research to more participants can optimize the patient population, reduce the need for overrecruitment based on expected downsizing, and make research more cost-effective. A holistic approach can remove barriers to admissions and improve industry benchmarks for recruitment and retention.
- Reduce test execution costs through virtual visits
According to the DCT design, a large number of research visits can be conducted remotely through the telemedicine virtual visit method, instead of requiring participants to go to the clinic for all visits. Since on-site visits are some of the key cost drivers in clinical research (that is, data collection for SDV, management, travel reimbursement, etc.), the need for specific in-person visits may have an impact on the research budget. The cost of telemedicine visits is 50% lower than the in-person clinical visits of the research sponsor, and in clinical care, they can also provide a higher profit per visit to the research site. In addition to telemedicine, other options for remote data collection include mobile-supported evaluations (ePRO), sensors (wearables, medical devices, etc.), home health visits, etc. Of course, there are costs associated with each of these data collection activities, but through technology and automation, some of the costs incurred in performing these assessments in the clinic can be eliminated.
- Reduce research management costs
Clinical trial management encompasses a wide range of costs, from staff time (administrative staff, clinical staff, etc.) to the cost of a specific location, such as diagnostic testing, imaging, etc. These costs increase as the number of sites and participants increases. Industry forecasts show that learning management costs can account for 11% to 29% of the learning budget. Reduce the number of clinic visits and increase the automation of data flow/cleaning, enabling the site to reduce some overhead and increase its profitability through the DCT method.
In traditional design research, on-site visits require many management tasks, including appointment arrangements, evaluation documents during the visit, and necessary follow-up activities. Through the technology platforms commonly used in DCT, most of these activities (forms, patient/observer/clinician report results evaluation submission, etc.) can be automated, thereby reducing the costs associated with administrative work.
- Eliminate source data verification
Source data verification (SDV) is a necessary step in traditionally designed clinical trials, in which the data in the case report form (CRF or eCRF) is compared with the information source to ensure that the data is correct. This adds a lot of labor costs and costs due to errors in the data transcription process. For example, a participant submits a diary entry (source data), which must then be compared and checked with a case report form. To ensure accuracy, the sponsor and/or CRO must review and monitor these interactions and implement SDV for each participant’s activity. The costs associated with SDV are high, and one study found that SDV accounts for approximately 25% of clinical trial budgets.
The DCT method allows data to be entered directly from sources (participants, caregivers, clinicians, and other research stakeholders). This eliminates the need for SDV and can result in significant cost savings. By eliminating the need for SDV during the trial, the SDV budget can be eliminated (up to 25% of the entire trial).
- Reduce costs by increasing retention, better participation, and better training
All research and registration try to optimize the retention rate of participants. Replacing participants who withdraw or withdraw due to poor compliance will increase costs. In order to maximize retention, participant participation is essential, and the platform can be used to facilitate easy communication between participants and the research team. Participants can receive feedback and information throughout the research process, allowing them to keep abreast of their own performance and the overall performance of the research. Remote technology promotes transparent and continuous communication between participants and clinicians, and allows participants to access their own data in real time. This helps to instill a sense of ownership in participants, thereby increasing participation and helping to maintain a high retention rate.
It is also possible to increase retention rates through powerful participant training and digital software platforms, providing an easy-to-use approach for continuing education. At the start of the study, DCT participants do not need to rely on clinical team members for training as in traditional research models. Centralized digital training and always-available support ensure that participants and caregivers can feel comfortable and confident in their data submission responsibilities, enabling them to effectively submit data during the research process. DCT technical facilities enable good participant participation and on-demand training, helping to optimize research retention and minimize costs.
Do the right thing and save money
The industry is working hard to bring new therapies to the market faster so that people can live longer and healthier lives. Use more DCT methods to serve this promise. It is now in the financial interest of everyone who conducts clinical research to do the right thing by making trials more accessible.
Photo: Wach, Getty Images
