I recently Googled ‘ophthalmic migraine’, and as I did this I left behind a tiny packet of health data. Think about all of the times you have Googled, searched YouTube or clicked on a Facebook link related to a health topic that concerns you or a loved one. Health topics and symptoms are in the top five things we search the internet and social media for.
Now imagine collecting all of the tiny data packets shared to social media or on the internet to build a picture of all the migraine sufferers in a geographic region. The tiny data packets together would create a map of symptoms, location, gender, comments on drugs or medical devices people have used, or techniques relied upon to manage the headaches.
This could potentially be a valuable data library for medical researchers working on new treatments and diagnostics or being able to identify a population relevant for an upcoming clinical trial or a new migraine drug.
Real-world data (RWD) and real-world evidence (RWE) are relatively new phrases that are used in the drug development and medical device industry. These terms describe the data that comes directly from patients that may be capturing information about their everyday movements, thoughts, results or actions while they are going about their everyday lives. This data may come from a variety of sources - Fitbits, apps, all sorts of wearable devices, as well as social media created by us, also known as user generated content.
National regulators of new medicines and medical technologies such as the Food and Drug Administration (FDA) in the United States increasingly use RWD and RWE to monitor post-market safety and adverse events, and to make regulatory decisions on a new product. The healthcare community is also using RWD and RWE to inform clinical practice and develop decision support tools for doctors. Additionally, medtech companies and drug developers are using it to design clinical trials and new product opportunities that are more aligned to what patients do, believe, act upon, value and want.
Data and evidence are critical in the drug and device development life cycle in creating inflection or value points that prove a concept, attract potential commercial partners and possibly deliver value to investors.
Most medical data we are accustomed to relying on comes from wearables or pathology results. But what about the data a patient creates via their own movement, experience and opinion – the data they share to social media every day, and in every key stroke as they search the internet on health topics, or comment in chat rooms and on websites, leaving behind those data crumbs or rather valuable clues about health issues and the treatments they use to manage disease, injury or disorders.
Listening to three days of talks at the MedTech Conference in Philadelphia recently, it was very clear that the potential and interest in capturing real-world data and evidence is expanding rapidly, with a number of companies investing significantly in developing capture, identification and analysis capabilities.
A particular speaker that stimulated a lively discussion was Michelle McMurray, Worldwide Vice President Regulatory and Clinical Affairs for Johnson & Johnson. She posed the idea that as innovators we need to re-imagine the role of real-world evidence and change the way regulators view evidence to support patient-driven innovation.
McMurray suggested we need to think of evidence as multi-purposed, challenging us to capture evidence and data across the entire product life cycle from multiple sources and to loop proactively where real-world evidence can substitute for or support clinical evidence, critical in medical device development. The FDA and other global regulators are certainly examining the role of real-world data and the variety of sources data can be collected from.
But there are growing data gaps in healthcare.
There is no doubt patients and the research and development industry can generate enormous amounts of data. The key gap is in knowing how to use the data and how to make sense of it.
The second data gap is in the changing relationship patients have with the internet. Social media is rapidly becoming a key tool in health education, compliance and patient-to-patient support, as well as a core recruitment tool to clinical trials.
The third gap is around data privacy and data ownership, and the growing harmonisation of data rights management around the world, kicked off by the General Data Protection Regulation (GDPR) in Europe this year.
Any data scientist will tell you that not all data is good data. And even if some data is good data, not all data can be used. Informed consent and rights management was a key topic at the MedTech Conference this year, with CEO of ResMed Mick Farrell leading a fantastic panel discussion on data rights in digital health. Farrell declared he (ResMed) was but a ‘steward’ of data and that the patient clearly owned their data. Jamie Haggard of Green Sun Medical agreed but added that the patient can’t necessarily interpret or use the data on their own and in partnership with the medical device company can be 'empowered'. Haggard said medtech companies need to ensure the device is valuable to the patient – not just the doctor or payer – and patients should be a part of the value chain, ensuring they are directly involved in their healthcare.
It seems to me that data providers and data analysis capabilities are the emerging heroes of the next generation biopharmaceutical and medtech development landscape. It’s critical that the industries interested in utilising user generated content – from wearables or from social media – have a social licence and that legislative and regulatory settings provide researchers with freedom, while consumers have adequate protection and fair commercial rights.
Companies and technology platforms that can capture, validate, aggregate, interrogate, analyse, secure and negotiate informed consent – compliant with privacy and ownership regulation around data and real-world evidence – will potentially be able to dramatically change the way we do medical research, lower the cost of development and deliver real world outcomes that improve the lives of millions of people.
Michelle Gallaher is the Managing Director of The Social Science, a social and digital consultancy company that is part of ShareRoot, a company focused on consumer data and privacy protection in the martech sector.