Not only must physicians and researchers identify suitable candidates for trials of life-changing and lifesaving drugs; they must also persuade these patients to take part and then keep them engaged during studies that may last several years. This often proves impossible: plans for some trials are shelved, because they fail to recruit sufficient numbers of participants; others have to be abandoned, due to high drop-out rates.
Diversity is also concern, because participation, in the US at least, is heavily skewed towards relatively wealthy, white males, with other groups seriously underrepresented. And that’s not just bad for scientific and medical progress - it’s bad for business, too. Without clinical trials that are able to explore the effectiveness and safety of new drugs and devices across a truly representative study base, companies may miss opportunities to make new discoveries and address new markets.
At ICON, a $2.6 billion contract research organization (CRO) headquartered in Dublin, Ireland, CIO Tom O’Leary is looking to identify technological responses to these challenges. The business case for doing so is pretty clear: ICON conducts trials and testing of drugs and devices, under contract, on behalf of large pharmaceutical, biotech and medical equipment companies.
At any one time, ICON is running clinical trials involving between 70,000 and 100,000 participants. Anything that improves the efficiency and effectiveness of these trials, including meeting the recruitment targets set out for them, boosts profits. But participation is good for patients, too, and not just because they’re ‘giving back’, says O’Leary:
Technology offers the opportunity, I think, to involve patients in clinical trials who might not have considered participating in the past, for many reasons. Many certainly haven’t considered that clinical trials could actually be a care option for them - but our evidence shows that patients involved in trials often fare better than those with the same conditions who aren’t. They’re more regularly monitored and have more consultations with physicians; they get more information about their condition; they get a much broader purview of the treatment options open to them and more targeted care; they’re exposed to novel therapies that may be more effective than existing ones; and, in general, they’re more engaged in the management of their condition.
Ultimately, O’Leary’s goal is for ICON to be staging and managing ‘virtual clinical trials’, which rely on IP-based conferencing and messaging technologies to support physician/patient consultations and wearable technologies to monitor patient vital signs and activities. The idea here, he says, is that these virtual trials reduce the burdens on a patient of participation (for example, taking time off work to attend regular clinic appointments) and effectively bring the trial to their own home.
This virtual approach, he explains, might most usefully be applied to Phase 2 and 3 trials, which tend to include hundreds or even thousands of patients with a particular condition, as they go about their daily lives, typically over several years. (As opposed to Phase 1 trials, which typically focus on small groups, who are closely monitored as in-patients in highly controlled clinic environments over a few days or weeks.)
It’s early days right now, but as a preliminary step, ICON has recently worked with systems integration company Dimension Data to implement a new unified communications and collaboration platform internally at the company. Introduced to replace multiple disparate and/or elderly PBX [private branch exchange] systems, this project has also brought new ways of working, such as instant messaging and videoconferencing, to ICON’s 13,700-strong workforce, via Cisco’s Jabber. It has also substantially lowered costs, O’Leary says.
Telemedicine, wearables, AI
But this is just the start. The new platform, O’Leary explains, is intended as a launching pad for a telemedicine approach, whereby communications tools will be extended beyond Icon’s own premises and workforce to other locations involved in clinical trials, including physicians’ offices and patients’ homes
As ICON studies the safety and efficacy of drugs and devices, we obviously need to gather data and information on many thousands of patients every year - and today, this data-capture process tends to take place when patients attend appointments with their physicians, in order to be assessed. But these visits are not always convenient for the patient, so there’s a great deal to be gained by facilitating virtual patient visits, whenever that’s possible and appropriate. Face-to-face visits should only need to take place when either the physician or patient elects to have that kind of appointment.
Beyond that, there are plans for greater digitalization of the clinical trials process, extending beyond communications methods and more deeply into data gathering, says O’Leary. Wearable healthcare devices and trackers an important part of the vision here, he says:
There have been significant advances in sensory and device technology with big implications for virtual clinical trials, in terms of making it much easier to gather up information in large volumes that could be critical to the development of drugs and devices, including patient activity levels, their vital signs, responses to medications.
We see this means of data collection as being more convenient and less intrusive to the patient; less burdensome to physicians and study nurses; and, importantly, a good way to engage patients in clinical trials, by enabling them to see how they are faring from the data and information being captured and how they are doing in comparison to other participants.
Finally, advanced analytics have the potential to make clinical trials both more efficient and more informative. In terms of efficiency, says O’Leary, predictive analytics are already being used in a limited way to forecast what might be needed for a clinical trial to be successful, based on previous trials - such as minimum number of participants or length of study.
In terms of being more informative, it’s now possible to integrate all sorts of external data types into studies in order to arrive at more nuanced findings. Air pollution or weather data, for example, might help explain why participants got more exercise (due to less pollution), or less sleep (due to high nighttime temperatures) during a particular period of the study. Says O’Leary:
There’s probably a number of drugs and devices that haven’t made it successfully through studies conducted in the past, because although doctors and patients saw benefits, researchers weren’t able to take account of external factors. Now, we have the opportunity to do that. We’re only scratching the surface… but it’s an exciting area to explore.