Can We Break The Digital Barrier In Clinical Trials?

Life Science Connect Editorial Staff

While the number of digital technologies designed for use in clinical trials is rising, adoption remains slow, with many trials still relying heavily on paper-based systems. Dan Schell, chief editor of Clinical Leader, hosted a recent webinar looking at which technologies have been most beneficial to clinical sites, as well as examining some of the barriers to adoption. Joining him were two experts, Robert Goldman, head of clinical operations at Techfields Pharma, and Thomas Moriarity, DO, a family physician and PI at SouthCoast Health in Georgia.

Complexity, Interoperability, And Change

Moriarty, who has been a PI for three years, said about half of the trials he’s been involved with have been paper-based, while the rest have used one or more technologies. Schell cited an Advarra 2023 Activation Study Report that reveals that electronic data capture (EDC) and interactive voice response systems (IVRS) are the most common technologies provided to sites while e-consent is the least common. Goldman confirmed that the report’s conclusions aligned with his experience. After noting that the term should really be IXRS (interactive web response systems), he explained that the cost of e-consent is the major hurdle for many in ClinOps. “You would be very surprised to see how expensive e-consent is because of all the fancy bells and whistles that go along with it,” he said.

Both speakers admitted that while they would like to use e-consent and other technologies more often in trials, not every demographic is a fit. Specifically, older and/or low-income participants may not have smartphones or consistent and reliable internet access needed for certain technology.

A poll of the webinar’s audience found that complexity of technology and interoperability were two of the biggest obstacles to adoption, followed by resistance to change. Moriarty speculated that the former two actually exacerbate the latter. “The interoperability and communication between systems can be a problem when running multiple trials with different sponsors who all use different systems for each trial,” he explained. “You end up with multiple passwords and multiple emails sent every day. It can be a little overwhelming at times.”

Goldman insisted that resistance to change is rooted more firmly in fear of the unknown among decision makers at sites. He asserted that sites are 1099 contractors and should be comfortable conducting trials the way they see fit. Those that are flexible or work with technology on a regular basis will reap the rewards of increased efficiency and insights.

Both speakers also conceded that it is better for the relationship with sponsors and CROs to be agreeable to any requested technologies. “I think as a site you have to be very malleable to what the sponsor wants,” said Moriarty.

Delving Into Decentralized Trials

Schell and the speakers discussed the role of technology in decentralized clinical trials (DCTs) and the types of problems they are trying to solve. Schell introduced data stating that only 1% of DCTs use ePROs while 52% use telemedicine. Moriarty recalled using telemedicine for a recent DCT that also involved a smart inhaler, which offered unique benefits. “Every time the patient would actuate the inhaler, the sensor would pick up on that, and then the patient would upload the data, and we would get an idea of how well controlled their condition is and how frequently they're using the medication,” he said.

Of course, there were challenges. “The patients would sometimes squirt a couple puffs into the air before they would actually use the inhaler, or they would lose the sensor or not upload data in a timely manner,” he said. “But overall, I think the technology works very well.”

Goldman offered details on a DCT involving CNS disorder that required dosing supervision. “Patients had a propensity to forget, change things, or maybe not be as honest as we would like them to be,” he explained. “So, we used an AI-enabled app where the patient would be required to identify their IP [investigational product] to their telephone. The app would identify if the IP was, in fact, correct, and then the patient would be instructed to take the medication. All of this would be in a video. If the AI detected any egregious behavior, such as not swallowing the pill or changing the pill, it would be quickly adjudicated by a live person.”

While patients had the option of doing the labs at home, Goldman said 80% preferred going to a site to have them done. He speculated this had to do with a multi-hour window for which the patient was stuck at home waiting for the lab tech to show up.

Staffing And Training

Technology is meaningless without personnel to use it, and therein lies a series of challenges for many sites. Goldman said that many sites are simply understaffed, and that makes learning and incorporating new technologies difficult. “Oftentimes CRCs are doing three or four things,” he said. “They're not just seeing the patient, right? At ‘well-oiled’ sites, they're going to have data entry coordinators, regulatory coordinators, a CRC, phlebotomist, and a director. But oftentimes, at small sites, it’s one person [performing many of these tasks].”

Moriarty expressed gratitude that many sponsors are good about providing training for technologies they want to see implemented. He said for most of his studies, sponsors were very helpful with training, offering both virtual and in-person options.  “So, I don't think there's a lack of training going on with the technologies that are required by the sponsor.”

However, Goldman pointed out that training can be difficult when there’s staff turnover in the middle of a trial. “As the trial is going and moving, those new folks who onboard don’t have access to that initial training from the stakeholder. So, they're at a disadvantage, and that's when you start seeing problems — this device isn't positioned correctly, this data isn't being input correctly, or this person’s not using the tech.”

Near the end of the webinar, both speakers briefly touched on the importance of documenting SOPs in ClinOps in general. Moriarty added, “I don't think we have a specific SOP for a particular tech adoption.  But we do have a list of lessons learned that we've accumulated over the last couple of years that we frequently refer to.”