Clinical supply
appears to be sparking a revolution in how trials are conducted. Spurred on by new monitoring platforms, clinicians are increasingly experimenting with remote trials, delivering medicines to subjects in their homes, then monitoring their effects via sensors and computers. Not that the direct-to-patient model is necessarily easy to implement. Especially when it comes to the vexed question of supply chains, clinicians have plenty to do before remote trials can become the norm, forced as they are to organise hundreds or thousands of deliveries direct to private homes. Get it right, though, and pharmaceutical development could be changed forever.
In-person problems In theory, direct-to-patient clinical trials have been around for years. As long ago as 2015, the FDA solicited feedback on using telehealth technology to improve trials. Yet, as Gaurav Agrawal explains, remote trials have traditionally struggled in practice. That begins, says the life sciences partner at McKinsey, with technology. To put it bluntly, sensors and monitoring devices just haven’t been sophisticated enough to be deployed in remote settings. Just take blood draws: until recently, they could only be done in hospitals and clinics. Órlaith Burke, the ‘data in health’ innovation portfolio lead at Accenture, makes a similar argument. “Traditionally, it has made sense to concentrate trials at investigator sites where experts can congregate to conduct the complex care and trial processes,” she says. “This has traditionally provided process, resource, and funding efficiencies for investigators.” That’s shadowed by more practical considerations too, especially when it comes to supply chains. For years, the logistics network simply wasn’t robust enough to cope with a decentralised supply chain – something reflected in the fact that only small corners of the US and Europe have historically embraced them. Yet, with recruitment problems persisting, trial organisers are having to adapt. According to one 2019 survey, after all, 14,000 oncology trials were actively recruiting, even as they were able to secure just 5% of the subjects they needed. These recruitment struggles aren’t hard to understand; trekking to an in-person trial location is tiring, especially if someone is already sick, and it’s not like clinics are always nearby. In the US, 70% of potential participants live over two hours away from a trial site. To put it another way, hard-nosed questions around recruitment are fundamentally changing attitudes towards clinical trials. Rather than seeing trials purely in terms of costs and output, the phrase of the moment is ‘patient centricity’ – an attempt to cater trials to subjects themselves, ideally in the comfort of their own homes. Clearly, this is ethically desirable in principle. But what really makes it feasible in the real world is a proliferation of new
Clinical Trials Insight /
www.worldpharmaceuticals.net Decentralised trial elements
While most clinical trials are not likely to be entirely virtual, they will use one or more decentralisation elements based on suitability for their end points, patient populations, and treatments. Many such elements have been widely piloted, with 48–95% of sponsors reporting use in at least one phase 3 trial. A significant increase in uptake is expected because of experience gained during the Covid-19 pandemic. Before the pandemic, an Industry Standard Research survey in December 2019 found that 38% of pharma and contract-research organisations (CROs) expected virtual trials to be a major component of their portfolios, and 48% expected to run a trial with most activities conducted in participants’ homes. When asked the same questions a year later at McKinsey’s Clinical Operations Roundtable, the responses
were 100% and 89%, respectively. Source: McKinsey & Company
technology, both in terms of data capture and logistics. “Advances in technology are one key enabler of this trend and include mobile technologies like smartphones, tablets, wearable devices, or web-enabled patient diaries,” says Agrawal. “Additionally, the establishment of electronic health records and advances in data management allows more seamless capture, processing and validation of data.”
“The pandemic has been the ultimate disrupter for all industries globally in the past century. We see so many innovations gaining momentum and increasing in popularity due to necessity. Direct-to-patient trials was a model used across the life sciences industry to keep numerous trials on their trajectory throughout the pandemic.”
Órlaith Burke, Accenture Direct access
Over the past 18 months, from the workplace to the clinic, the realm of the possible has been pushed to its limits. That is just as true when it comes to clinical trials. If rapid developments in the field, from patient centricity to better technology, have revolutionised the process in theory, both Agrawal and Burke agree that Covid-19 has finally brought direct-to-patient trials centre stage. As Burke puts it: “The pandemic has been the ultimate disrupter for all industries globally in the past century. We see so many innovations gaining momentum and increasing in popularity due to necessity. Direct-to-patient trials was a model used across the life sciences industry to keep numerous trials on their trajectory throughout the pandemic.” What does all this actually mean for patients themselves? For one thing, they no longer need to slog to trial centres for check-ups. For another, clinicians can use all those patient diaries and wearable devices to understand a drug’s effects remotely. More to the point, these innovations offer a number of practical benefits, from quicker results to cheaper medication. Decentralisation also makes it easier to recruit for
Opposite page: Although using new technology, clinicians are experimenting with remote trials and delivering medicines to patients in their homes.
21
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45
