I just read this April 2016 dated article by April Schultz, Content Marketing Manager at Forte (a company that offers software products and an array of services to help organizations conduct research), and found it very interesting as it’s trying to make the case that ‘mobile health should not be used for every clinical trial‘.
I think in 2017 when everyone working in the Clinical Trial industry is walking around with a supercomputer in their pocket we should have arrived at realising that every clinical trial would benefit from mobile first design (watch this presentation I gave in 2015 on How Mobile First Clinical Trials & Ratings will transform the $100B Clinical Research Industry to appreciate what this means).
“With the development of exciting new digital technologies, the clinical research industry now has the tools to make clinical trials more patient-centric than ever before. In particular, the emergence of wearable and mobile health technologies have the potential to greatly advance patient-centricity in clinical trials through real-time data collection and participant engagement”
This is a long held bugbear of mine (eg. in 2009 I wrote about how successful mHealth applications are already here) but I can’t for the life of me understand why people talk about mHealth as something new. There’s nothing I’ve worn (carried with me at all times) more than my mobile phone since I first got one in 1995.
Why do people think we’re talking about a ‘potential’ opportunity. Visit Apple’s ResearchKit website and watch some of the videos they’ve produced and you’ll soon put these outdated notions to rest:
Yes most clinical trials are complete dinosaurs (eg. 99% of data is still collected within the four walls of a clinical research facility building) but it should be obvious that participant engagement in clinical trials is no longer something that the Clinical Research Organisations are very good at or have a monopoly on eg. check out how companies like FullPower have supported millions of their customers to share millions of nights of sleep data to not do something as simple as measure the value of a single drug but to build the Sleeptracker Artificial Intelligence Engine that is today improving the sleep for Ms. and Mr. Everyone via actionable personal insights into small adaptations that can improve sleep. In 2017 the Clinical Trial industry is being leap frogged by innovators who have adopted mobile first strategies and it’s no longer fair for companies to suggest it’s ’emerging tech’ with unproven ‘potential’ just because they’re not doing it yet…
“However, it’s important to make objective decisions about the use of mobile technology to maintain a truly patient-centric trial design. As exciting as mobile health is, some technologies may impede the patient-centricity of a trial, making participation more difficult for some individuals”
This seems to be a crafty way to use social media to add legitimacy to a claim (I thought the embedded link would take me to somewhere that discussed why mHealth impedes the Patient-centricity of a clinical trial) but it’s just a means of promoting a very outdated position that Forte are taking (probably to protect their business interests and stop clients dropping subscriptions to their software and moving business to Apple ResearchKit partners):
A year on and I suppose it’s positive that only one twitter user has supported the companies position:
“Why mobile health should not be used for every clinical trial. As described above, mobile health has a lot of potential in the clinical research space and could make the clinical trial experience much more patient-centric. However, these technologies may not be appropriate tools for every trial. It’s essential to be sure you’re using tools that enhance the patient experience and ensure data integrity. For some patient populations, mobile health could prove detrimental. When determining whether mobile health is appropriate for your clinical trial, evaluate and characterize your participant population and their relationship with digital technology. Also take into account the feasibility of a mobile health study and assess whether you have the necessary resources to provide the best participant experience. Answer these key questions when considering mobile health for your study:
What is the age range of my participant population? While younger generations are very adept with technology, seniors may struggle to use mobile health applications or devices. Using mobile health for an older demographic may require research staff to provide extra training. Such trial design could also inconvenience an older patient population as it may require them to perform atypical tasks and significantly alter the way they function throughout the day.”
I think this conclusion is reached because of a couple of common misconceptions about older people being resistant to using tech and mHealth being just about smartphone apps. I think it’s important to note that there’s no reason not to think of mHealth as also including the opportunities we have to embed mobile connectivity into sensory devices that seniors already use to manage their health.
“Do the majority of my participants have smartphones? The demographics of your participant population, including age, financial status, location, as well as a variety of other factors, could influence whether they have access to a smartphone. If some of your participants don’t have smartphones, will you provide them the necessary technology? This could prove logistically difficult and limit the amount of eligible study participants in your target population.”
This position stuns me because everytime I see a rep from a drug company they’re wielding the latest tech from Apple iPads to iPhones and even Apple Watch yet when it comes to the Patients who make their clinical research possible the idea of gifting an inexpensive smartphone is just out of the question a step too far. Time to get your priorities right and at the bare minimum stop telling us it’s preposterous for you to think about investing this much in your trial participants (most trials today cost in excess of $100k per Patient so relatively the gifted mobile is insignificant).
I think it’s an endemic issue with the current design of the clinical trial industry as you would think it’s obvious that the pharma brands should just reinvest the money they save on the use of clinical research facilities and reimbursing all the travel etc but it doesn’t typically work like that because most clinical trials are still outsourced (usually to the CRO that bids the lowest price) and aren’t branded by the drug company that pays for them (this is another important reason why Apple ResearchKit ratings are going to completely disrupt today’s conventional outdated way of doing things).
“Is real-time data truly necessary for the benefit of my study? The potential of mobile health and real-time data is exciting and it’s tempting to take advantage of the technology regardless of whether your study will truly benefit from its use. Critically evaluate whether the costs of using mobile health (such as those listed above) are worth the benefits of real-time data. If the benefits fall short, it may be best to opt-out of mobile health and design a trial better suited to the needs of your study and participants.”
This is a typical mindset view of people I meet who work in the CRO industry. They can’t see any value beyond the tightly defined measurement requirements that they’re being paid to collect in their specific trial. The idea that the big data sets collected during a trial could be reviewed and processed by someone else or at a later time to draw other insights that weren’t perhaps clear when the trial was being quoted for is of no interest because most trials today are run by CROs who are focused on cost. Most trials today in Europe fail because they don’t recruit any/enough Patients or because the CRO tried to run them on too tight a shoestring.
“While mobile health technology could revolutionize how the clinical research industry conducts clinical trials, patient-centricity relies on the industry’s focus on building a positive participant experience. Regardless of whether mobile health is incorporated into study design, it’s essential to design each trial with the participant’s best interests in mind”
It’s no surprise that Mobile companies like Apple and Google are wiping the floor with brands in the CRO industry because they are so clearly out of touch with the business they’re in. How could a Mobile First approach not achieve a more ‘positive participant experience’ to what we have today where most Patients don’t know that clinical trial opportunities exist, aren’t being recommended to them by Carers, can’t find reviews of clinical trial experiences, etc, etc.