We know from almost 20 years’ experience that patient-centric trials can drive:
- More community trial support services to allow more visit types to take place in the home.
- New types of data to collect.
- Sites adapting to different patient distributions and demands.
- Regulations to adapt to new roles and realities.
Looking at each of these in turn:
More community trial support services are needed to reduce the cost of providing services in the home and to make more types of visit possible to run in the home or local community. MRN data indicates we typically undertake about half the visits of a trial in the home. To increase this, we need to take more of the services that presently come from the hospital and move them into the community. MRN aim to be able to increase this towards 75% in the near-term future as we work on new ways to conduct activities of trials in the community which presently take place in the site but don’t really need to – eclinical is already adding to our capabilities as are our drug storage, distribution and logistics capabilities.
New types of data to collect. The movement of consumer-focused digital devices – smartphones and smartwatches in particular – into mainstream health monitoring is leading to a potential for some profound developments. The Apple Watch validating its ECG monitor for the detection of arrhythmias gives medicine a type of trial that has never been possible before, based on huge epidemiological data sets – certainly for observational types of studies and very likely for interventional designs as well.
Data volumes will explode – both based on numbers of people generating data and from the streaming of data from any given individual. That will challenge us to manage the data certainly, but also to interpret it. Physicians today do not base any of their diagnostic or prognostic decisions on streaming data, so they are going to have to learn about what it means. We are also already seeing new types of digital-enabled efficacy data, such as those programmed into smartphones that measure the time spent sitting by Parkinson patients and have correlated that to final endpoints to provide early warning of deterioration and improved therapy.
Traditional data will also develop. More equipment that measures complex medical parameters to allow more complex assessments to be done in the home. Devices to examine (visualize, hear and even touch) patients better, operated by the patient or a local operator such as a nurse to share with the physician over a telehealth link.
Sites adapting to different patient distributions and demands. Moving a trial into the community allows patients to choose not only where they are seen in a trial, but when. MRN data shows around 80% of our visits do not take place when the visit clinic at the site would take place. As patients can be seen from further away from sites, there will eventually be many more patients per site, either their own or referred to them. This means more resources in those sites to cope with the volume of patients. If telemedicine can allow one site for the USA – or even 10 regional sites – then they will be looking after 10s or 100s of patients, significantly more than the present average. They will need to equip themselves to do that and get much better at referrals from other sites. Ultimately, we will see fewer, bigger, more focused sites, who will perhaps even be competing for patients to self-refer for the trial.
Regulations to adapt to new roles and realities. As sites become less physically defined and patients stay in their local community for trials, getting physically much further away from the sites, the PI will find it harder to provide the full care for that patient. This will mean the local medical set up will need to support the patient throughout the trial. Patients will like that, as they will not have to lose the relationship they have with their long term physicians. Their usual physicians and other carers will have to know more about the trial activities so the boundaries between trial and routine care will have to be reconsidered. Who is responsible for what will be different. The local physician will be perfectly capable of determining if the patient is generally well or not if the safety data shows them to be safe and the efficacy data shows them to be effectively treated. But they need not be the PI – or really even part of the study, just because they see the patient to make sure they are OK, instead of the PI seeing the patient to give the same general medical opinion. Roles and definitions will shift – sometimes subtly, sometimes seismically. The way monitors look after the elements of the trial will change as the distribution of those parts is changing. Data cleaning will take on new dimensions – we have already seen how data will change but we also need to look at how data is verified and updated. All of these impacts mean the regulators will have to react.
Evolution or revolution? Well – a bit of both I think. Of course, the majority will be evolutionary in nature – the whole set up is just too complex and interwoven to blow it all up and start again. But the rate of change is faster than I have seen in my career, so the seismic tremors caused by these changes might be slightly higher on the Richter Scale than we are used to in an otherwise slowly changing environment.
Graham Wylie, Executive Chairman MRN