A ‘tsunami of change’ is coming to the conduct of clinical trials according to Dr Rob Scott, chief medical officer and global head of development at AbbVie.
Dr Scott spoke to PharmaDispatch during a short visit to Australia late last week.
The Zimbabwean-born Scott started his thirty-year career in industry with Johnson & Johnson in South Africa. He subsequently held senior global positions at a number of pharmaceutical and biotechnology companies, including Pfizer and Cerenis Therapeutics.
He has seen many changes in the conduct of clinical trials during his career but says much has also remained the same over the years.
“There has been an explosion in our understanding of biology and generics in the past decade, with new targets and approaches, in all areas but particularly oncology. We’ve made a lot of progress and while we’re not winning yet there are a lot of new and exciting treatments.”
An area of current and future rapid development is digital health in clinical trials.
“There has been a lot of hype, conferences and meetings talking up what has really been ‘vapour’, but we’re starting to see companies do interesting things.
“What we’ve seen are devices to capture patient recorded outcomes. We started the process of phasing out paper diaries twenty years ago. The first generation was palm pilots but the move has been to mobile devices.
“In terms of what next, it’s a tsunami of change, with mobile apps to create a more immersive experience for patients. This might include reminders for appointments or to take their drugs, and we can also collect feedback from patients, such how they’re feeling.
“Beyond that it will be wearable devices to capture physiological data. We currently have at least three studies capturing data from wearable devices. This includes sleep quality for patients with dermatitis - which is important - we capture movement from an Apple Watch that gives us good data.
“Also trials involving movement disorders, such as Parkinson’s disease. We measure gait with motion sensors, which can be worn on a wrist or ankle, that can help indicate whether the drug is working.
“We don’t yet know whether it improves the data but time will tell,” says Dr Scott, expressing confidence it will.
“If you think about something like Alzheimer’s disease, where patients might do formal cognitive measurements four-to-five times over two years, wearable devices mean we can measure every day making the data more robust.”
He says regulators may not necessarily accept the benefits of the data but it has “tremendous value” to companies in helping to determine dose levels and the direction of later stage clinical trials.
“The future will see more use of wearable devices in trials. The Google contact lens is measuring blood sugar and implants in the aortic wall could provide a continuous measure of blood pressure.
“We will be recruiting more online, using platforms like Skype to communicate, and capturing the information we need via mobile technology.
“We won’t be sending armies of people to attend trial sites. The current process of patients having to go back and forward is inefficient. It could be even be global. We’re already doing this with Australian-based teams monitoring sites in other countries.
“This will also make it a lot more cost-effective,” he said.
“Cost is very important given the scale of emerging pipelines. We can’t afford to do everything. We need to do more with the same amount of money so that means adopting new technologies that make it more cost-effective.
“In that respect, change is simply an economic imperative.”