New Trial Approaches Have Strong Benefits, but Industry Worries about Complexities
Trial methods adopted during the pandemic yield timely, high-quality and useable data, industry says, but sponsors also have concerns about how these approaches add complexities for sites and investigators.
A recent global survey conducted by Oracle Health Services and Informa Pharma Intelligence showed that nearly half (48 percent) of the respondents said new approaches made data timelier, 30 percent said data were both more frequent and of higher quality and 23 percent said data were more robust.
In total, almost all those surveyed (92 percent) said they were confident in the data collected compared to data gathered using prepandemic methods: 37 percent were equally confident, 35 percent were somewhat more confident and 20 percent were much more assured in data obtained using new approaches. A minority — 7 percent and 1 percent — said they were somewhat less and much less confident in the data, respectively.
A vast majority of respondents were able to make use of most (53 percent) or all (34 percent) of the newly generated data, according to the survey. Just 13 percent said they could use some of the data and a mere 1 percent reported they couldn’t make any use of them.
The survey, which involved 251 respondents from CROs, devicemakers and a range of biopharma firms, found that a strong majority (82 percent) saw a positive impact on their trials when using newly adopted approaches like remote monitoring, video visits, phone visits, eConsent and electronic health records (EHRs). One in four respondents noted a “significantly positive” effect on their trials, while 16 percent noted no meaningful impact and only 3 percent said the approaches caused problems.
Additionally, 41 percent of respondents cited improved flexibility for patients, more than a third (38 percent) cited increased trial speed, 29 percent noted increased protocol compliance and a quarter said patient retention was improved when using pandemic-era methods.
But the 217 respondents who said they planned to keep at least one newly implemented approach had their concerns about continued use. Topping the list, 37 percent said it led to more complex work for site staff/investigators and 36 percent named increased data quantity as a consequence.
“I think the systems are still built for the old methodology of clinical trials, how we manage them [and] some of the ways we use some of the data collection methods. We’re throwing in new things and I think we have to be able to make that simpler,” Jim Streeter, global vice president of life science customer success at Oracle, said. “I think technology is always going to keep moving ahead. We’ve had these technologies for a while but now we need to scale it, and that scaling is where you get efficiencies, where you make it easier to use. The feedback from sites tells us right away that they feel overwhelmed. There’s complexity there.”
A lesser number of firms named more complex protocol design considerations (24 percent); increased vendor management (21 percent); the need for additional site/patient training (20 percent); increased participation options (13 percent); and the need for additional IRB approvals (12 percent) as consequences of continued use.
Respondents were asked what specific trial approaches they employed in response to the pandemic. The most common approach was remote monitoring (45 percent), followed by video visits (37 percent), phone visits (35 percent), eConsent (28 percent) and EHRs (26 percent). Those surveyed also listed a variety of other methods, including patient apps, home healthcare, mobile health wearables, central/local labs, central monitoring and others.
Read the full report here: https://bit.ly/3bbuREX.