The last blog post on “FDA – Real World Data draft guidance” stimulated some interesting conversations, including a debate about what clinical trials will look like in 5 years’ time.
There was agreement on some things, like there’ll be more patient choice and patient engagement. The inclusion of Electronic Health Records (EHRs) is helpful and likely to help with patient recruitment. And there’ll be more technology in the form of AI and wearables. And all of these changes will result in massive data volume increases.
And then opinions about the impact of increased use of technology started to diverge. Some people thought that increased technology will result in simplification for both patients and sites. Others disagreed, especially about the future implications for sites.
I was also reminded of the Ken Getz interview on “the impact of Decentralised Clinical Trials post COVID” with Liam Eves on The Endpoint Podcast. In it, Ken says that sites are probably going to see the most profound changes of any segment in the drug development enterprise. While many in the sector are saying “there’s no going back” and that trials will always be virtual and remote from now on, the reality is likely to be very different. Sites have reported on the many difficulties in running trials during the pandemic. These included the introduction of new technologies, which sites report has contributed to increased start-up times, workloads, and uncertainties. All of which introduce the potential for errors, resulting in reduced quality. The exact opposite of the desired outcome. I also noted with interest the frustration of sites in having to educate new technology vendors who have never been involved in clinical research before.
I don’t think there’s much doubt that hybrid approaches of on-site, remote, and central monitoring will be the norm, not least because in our experience that’s what Sponsors are now pushing for. There will be challenges around data and interoperability, especially with the ability of legacy systems to deal with the influx of huge volumes of data. But I think one of the most immediate challenges is the ability to structure data in a meaningful way that enables teams to make accurate and timely decisions that will reduce risk and increase patient safety.
The question “What will clinical trials look like in 5 years’ time?” will never go away because the answers are constantly changing.