There is ongoing and increasing interest in using digital health technologies (DHTs) in clinical trials for clinical endpoints. By changing the yardstick by which outcomes are measured, DHTs have the potential to improve the accuracy of results and/ or reduce the sample size necessary to achieve the required significance level. They can also be used to add label claims for secondary effects.
However, the desire to add DHTs to clinical trials may be hampered by the growing site capacity problem. The number, size, and complexity of clinical trials keeps increasing. The number of new drug candidates has doubled in the past 10 years. All must be tested in clinical trials. Furthermore, the average cost of a single trial has increased by 76% over roughly the same period. If one assumes that cost is roughly equivalent to effort, the demand for clinical site capacity is roughly 3.5 times higher than 10 years ago. In addition, clinical sites are not immune to the ongoing cost and productivity pressures that affect the entire healthcare system. As a result, site capacity has become a significant challenge when conducting clinical trials.
Impact of Decentralised Trials
Decentralised clinical trials (DCT), where a remote organisation manages the complete trial, were employed extensively during the COVID pandemic when there was little choice. It quickly became clear that a full DCT approach was difficult, if not impossible, for most trials. There are almost always tests and assessments that must be performed at a clinical site. Furthermore, principal investigators must provide medical supervision. The emphasis has now swung to “hybrid” trials, where certain functions that need to be performed in a central location (e.g., MRI scans) are done at the site. Activities that can be performed remotely (e.g., recording electronic patient reported outcomes, ePROs) are done remotely. Hybrid trials have helped somewhat, but some of the benefits of reducing site visits have been mitigated by increased coordination efforts with the remote functions. Thus, the overall impact on site capacity has been minimal.
This is not to say that hybrid trials provide little value. Reducing the number of site visits for participants is incredibly important for reducing the burden of participating in clinical trials. It also makes it feasible to enroll participants from a wider geographic area. Enrolling participants is almost always the chief roadblock in executing clinical trials quickly, so anything that can be done to improve that is vital.
The Site Burden
Although it may seem like DHTs shouldn’t be much of a burden to sites, the reality is that they are. Sites need to manage the inventory of DHT devices for patients to take home, but they are generally not set up to do that. They don’t have the space or the processes to become a warehouse. Beyond the hardware for patients, there is typically another platform that sites need to keep track of and use to monitor compliance on a regular basis, often daily. Clinical sites often have upwards of 15 different logins for each trial. Given that sites often have only a few participants at a time in a particular trial, logging on to yet another system to check on them creates a significant additional burden on a per participant basis.
Furthermore, every tech vendor has their own platform, and it is not reasonable to expect site staff to master all of them. Even routine questions require site staff to involve the vendor, putting an additional burden on the vendor and clinical research organisation (CRO). For example, even the most routine of events, like a participant not wearing a device, becomes a significant project. To avoid potential confusion, many trials require that there be a single point of contact for each site. What usually happens is that the DHT vendor notices the non-compliance issue first. The vendor must notify the CRO, and copy the sponsor. The CRO then contacts the site involved (while copying the sponsor and tech vendor). The site then calls the participant (often only making contact after several tries). If the participant has any technical questions, the communication often goes back up the chain to the supplier. In a recent non-wear example, getting a participant to start wearing their watch again took six emails with about 20 people on each, plus several calls to the participant from the site.