Even after clinical research sites have reopened, it’s clear most sponsors and sites won’t be returning to the way things were before the pandemic.
After more than a year of remote monitoring, IMARC’s own research shows that most researchers prefer a hybrid approach that combines both remote and on-site activities.
However, it’s important to consider how this transition will affect the cost of clinical trials.
What Do Medical Device Clinical Trials Cost?
The cost of clinical trials varies significantly depending on the risk level of the device and whether it’s a new device or “substantially equivalent” to one that’s already on the market.
Most medical devices receive approval through the 510(k) process rather than the pre-market approval (PMA) pathway required for new and/or high-risk devices. The cost to obtain approval through the 510(k) process is about $31 million, according to DrugWatch, compared to $94 million for the PMA process.
While some of that cost is the medical device user fee, which is now up to $365,657 for PMA applications, the majority of the cost of clinical trials is the research portion.
That includes recruiting and enrolling subjects, conducting the research, and completing monitoring activities throughout the trial to ensure compliance.
How Does The Cost Of Remote Monitoring Compare To On-site Monitoring?
On the surface, remote monitoring seems less expensive than on-site monitoring — and often, it is.
Reviewing documents remotely eliminates the costs of travel, lodging and meals that often accompany on-site monitoring visits.
In our survey of more than 100 clinical research professionals, 32% said remote monitoring has somewhat reduced their clinical trial costs, while 23% said the savings were significant.
Twenty-five percent said it had no impact on costs.
However, remote monitoring can add to clinical trial costs in other ways.
Twelve percent of our survey respondents said they saw somewhat of an increase, and 9% said that the increase to their clinical trial costs was significant.
The cost of new technology
Gaining secure access to data often requires new technology investments, such as an electronic data capture (EDC) system and/or another system purchased to manage file-sharing. Monitors who work conduct activities remotely will need to ensure they have appropriate equipment to access patient data.
They also need the ability to use a webcam and video conferencing system to interact with site staff effectively.
Ensuring compliance while monitoring remotely requires additional considerations. Many monitors need additional training to properly review informed consents, access electronic regulatory files, or use new EDC or electronic medical records (EMR) systems.
Forty percent of our survey respondents said managing electronic file-sharing was the most significant challenge they faced when transitioning to remote monitoring.
Another 13% cited the challenges of training their teams to use new technology.
Preparing for remote monitoring visits
Preparing for remote monitoring visits can also take more time because monitors need to ensure they receive everything they need to conduct their visit prior to the start of the visit. Sites often need to scan and upload printed documents and/or set up access to electronic medical records, for instance.
In fact, one-third of survey respondents said remote monitoring significantly increased the time it took their teams to prepare for a visit, and another 25% acknowledged some increase.
Hiring a clinical monitoring CRO
Finding well-qualified monitors can be a challenge, and in an industry with high turnover, keeping them is even more difficult. A contract research organization can assist with remote monitoring, provide oversight to ensure compliance, and help train your team.
About half of our respondents said they currently use a contract research organization to assist with monitoring. While it’s unclear whether the transition to remote monitoring made them more or less likely to hire a CRO, it’s an additional expense your team may need to consider.
How Can You Keep Monitoring Costs In Check?
While remote monitoring eliminates travel costs, sponsors may need to reallocate that money to invest in new technology, pay for additional staff hours, or cover the costs of training.
Be sure you account for these costs as you plan your clinical trial budgets. You should also consider which activities are best performed remotely and which would be more ideal (and potentially more cost-effective) in person.
If you decide to hire a CRO to provide additional support, be sure you understand their fee structure.
Do they charge by the hour, or per project? How do they account for unexpected changes that could lead to additional costs? How often do they check in with you to ensure you are staying within your budget?
As an experienced medical device CRO, IMARC is committed to helping you stay within your budget so you can earn approval without added stress.
To learn more about how to adjust your clinical trial planning to support the new hybrid approach, download our latest whitepaper.