Technological innovations have enabled the adoption of decentralized and hybrid clinical trial models (DCTs) at scale. DCTs make clinical trial participation more accessible to more participants, allowing for remote data collection and greatly reducing or outright eliminating the need for in-person clinical visits.
Additionally, clinical trial models that reduce the need for frequent in-person clinic visits enable sponsors to expand their potential participant group while simultaneously reducing the participant travel burden.
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John Reites John is the president of Thread. He is an executive intrapreneur turned digital health entrepreneur. John’s career includes 17+ years leading global drug development and healthcare innovation. As President of THREAD, he leads the organization to enable our customers to launch, adopt and scale Virtual Visits + eCOA for their decentralized studies. Named […]
Still, there persists the notion that this kind of expansion will make trials more expensive. The truth is that the more study leaders utilize DCT approaches to expand access to eligible patients and introduce new efficiencies into studies, the more costs they can remove, thus reducing research costs overall. The following are five ways in which DCT approaches can help to save money.
- Reducing Costs Through Better Recruitment
Poor participant recruitment is a common and costly inefficiency in clinical trials. In general, participant recruitment makes up as much as 40% of a given clinical study budget. To reduce costs, many study leaders find themselves under pressure to shorten recruitment timelines. While this may make sense, in theory, it is extremely difficult to accomplish in traditionally designed studies. This is because these studies are limited to enrolling participants who live within a reasonable proximity to study centers. The term “reasonable” is subjective, as more than 70% of clinical trial participants live two or more hours away from a study center.
On average, traditionally designed clinical trials experience an attrition rate of 30% for participants already. Shortening timelines actually locks studies into less-than-optimal enrollment and subsequent poor care plan adherence and high dropout rates – increasing cost.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Instead of focusing on shorter recruitment timelines themselves, sponsors have the opportunity to develop study designs that make study participation easier and more accessible. DCTs offer the opportunity to make participating in a clinical study easier for the majority of participants and make studies more accessible for potential participants who live even further away from study centers. Without the need to perform all assessments at a clinical trial site, sponsors can greatly expand the geographic area the trial can successfully recruit from. Opening studies up to more participants optimizes the patient pool, reducing the need to over-enroll based on anticipated attrition, and enables studies to be more cost effective. The overall approach can remove barriers to enrollment and improve on industry benchmarks for recruitment and retention.
- Reducing the Cost of Trial Execution with Virtual Visits
Depending on the DCT design, a significant amount of study visits can be conducted remotely via telehealth virtual visit approaches as opposed to requiring participants to travel to a clinic for all visits. As on-site visits contribute to some of the key cost drivers in clinical research (i.e. data capture that requires SDV, administration, travel reimbursement, etc.), eliminating the need for specific in-person visits can have an impact on study budgets. Telehealth visits can cost as much as 50% less than in-person clinical visits for the research sponsor, and, in clinical care, they can also provide a higher profit margin per visit for the research site. In addition to telehealth, other options for remote data collection include mobile-supported assessments (ePRO), sensors (wearables, medical devices, etc.), home-health visits and more. There are, of course, costs associated with each of these data collection activities, but through technology and automation, some of the costs that would be incurred by performing these assessments in the clinic can be eliminated.
- Reducing Study Administration Costs
Clinical trial administration contains a broad range of costs ranging from employee time (administrative staff, clinical staff, etc.) to site location-specific costs like diagnostic testing, imaging and more. These costs increase as the number of sites and participants increase. Industry projections show that study administration costs can account for 11% to 29% of study budgets. Reducing the number of in-clinic visits and improving automation of data flow/cleaning enables the sites to reduce some overhead and increase their profitability with DCT approaches.
In traditionally designed studies, site visits require a number of administrative tasks including appointment scheduling, the documentation of assessments during the visit, and necessary follow-up activities. Through technology platforms commonly used in DCTs, much of these activities (forms, patient/ observer/clinician reported outcome assessment submission, etc.) can be automated, reducing costs associated with administrative labor.
- Eliminating Source Data Verification
Source data verification (SDV) is a required step in traditionally designed clinical trials where data in the case report forms (CRF or eCRF) are compared to the source of information to ensure that the data is correct. This adds significant labor cost as well as costs resulting from errors made during the data transcription process. For example, a participant submits a diary entry (source data) that must then be compared and reconciled with the case report forms. To ensure accuracy, the sponsor and/or CRO must review and monitor these interactions, performing SDV for each participant activity. Costs related to SDV are high, with one study finding that SDV accounts for approximately 25% of clinical trial budgets.
DCT approaches allow data to be entered directly from the source – participants, caregivers, clinicians and other study stakeholders. This eliminates the need for SDV and can result in significant cost savings. By removing the need for SDV in trials, the SDV budget – which can be as much as 25% of the entire trial – can be eliminated.
- Lowering Costs Through Improved Retention, Better Engagement and Better Training
All research studies and registries seek to optimize participant retention. Replacing participants who drop out or are withdrawn due to poor compliance adds cost. To maximize retention, participant engagement is critical, and platforms can be utilized to facilitate easy communication between participants and the study team. Participants can receive feedback and information throughout the study, keeping them up to speed on how they are doing and how the study overall is performing. Remote technologies facilitate transparent and constant communication between participants and clinicians and can provide participants real-time access to their own data. This helps to instill a sense of ownership in participants, resulting in better engagement and helping keep retention high.
Retention can also be improved through strong participant training and digital software platforms to provide easy to-use pathways for ongoing education. At study startup, participants in DCTs do not need to rely as much on clinical team members for training as they do in traditional research models. Centralized, digital training and always-available support ensure that participants and caregivers can become comfortable and confident in their data submission responsibilities, setting them up to effectively submit data over the course of the study. The facility of DCT technology to enable good participant engagement and on-demand training help to optimize study retention and minimize costs.
Doing the Right Thing and Saving Money
The industry is working to bring new therapies to the market faster that enable people to live longer, healthier lives. Employing more DCT approaches serves this commitment. Doing the right thing by making trials more accessible is now in the financial interest of everyone conducting clinical research.
Photo: Warchi, Getty Images
John is the president of Thread. He is an executive intrapreneur turned digital health entrepreneur. John’s career includes 17+ years leading global drug development and healthcare innovation. As President of THREAD, he leads the organization to enable our customers to launch, adopt and scale Virtual Visits + eCOA for their decentralized studies.
Named one of the Top 100 Influencers in Digital Health, John provides expertise and execution experience in digital health strategy, remote patient research, virtual clinical trials, Phase I - IV clinical research, patient reported outcomes, patient engagement and mobile health. He is also a regular keynote speaker at global industry events, guest lecturer at Duke University on digital health/innovation and a published author featured in various conferences, journals, articles and media outlets. Connect with John on LinkedIn and Twitter.
