Ian Bolland spoke to Dr Simon Rudland, GP and Digital RWE advisor, and Peter Brady CEO at Orbital Research about Digital Real World evidence (RWE). They discuss research techniques and the findings of a white paper based on sourcing responses from social media: ‘Social Media-sourced Real-world Evidence – A Novel, Cheap, Effective Method, published in IPI Technology’.
The Social Media process – how much do you feel it has to evolve? Have there been any issues you’ve had to overcome e.g. sampling? And if so, how?
SR: With any research technique, the more specific you can be regarding your questions and sample group then the more likely it is that you’re going to yield information, which will help address your study questions. The use of social media enables a large number of real-world individuals to be reached, one of the great strengths of this methodology. However, it’s really vital that the questions are structured in such a way that you understand who you are sampling.
PB: Orbital Research offers a unique, robust and comprehensive Digital Real World Evidence
methodology for generating credible healthcare research. The innovation of the methodology has centred upon developing product claims for existing general sales list medicines and medical devices, at a tiny fraction of an RCT’s cost. This has been referenced by many within the healthcare industry as a “game changer” worth billions of pounds.
Further to this, the Digital Real World Evidence methodology can be deployed for a wide variety of other uses, such as label comprehension studies, ingredient defence studies or medical device, post marketing data collection compliance. Moving forward, the methodologies evolution will focus on streamlining and developing its multitude of healthcare research uses. As with its original development, the key challenges will be to ensure that we align with the highest standards of medical research, whilst ensuring that the data capture process via digital technologies is as frictionless as possible.
How much of an effect do you think the cost saving potential of such an approach can have on medtech companies?
SR: I think there are really exciting opportunities to reduce costs but there is a caveat here. You pay for what you get, and if you want real world methodologies to be delivered effectively and professionally then the right budget is required.
PB: I think the implications for medtech companies could be substantial. Providing cost effective, robust, real-world evidence, to support an innovative product in the marketplace, could be transformative for the industry.
The white paper refers to clinical trials as a snapshot in time – does this method allow more snapshots or more of a real-time offering?
SR: Real-world evidence will always be gathered over a period of time. However, depending on the access to the users of a product through a social media platform, it is possible to capture views from large numbers of individuals, hundreds or even thousands, quite quickly - over a matter of weeks, which would be quite difficult with conventional research techniques.
PB: Digital Real World Evidence allows the collection and evaluation of data captures over finite periods of time, from large cohorts. These real-world data captures can be repeated if required.
Do you feel this method involves patients more in the information supply chain?
SR: I think the answer to this has to be yes. This technique does not select out cohorts from the user groups to the extent that a traditional randomised controlled study might, which in turn, hopefully provides you with information from the true user group.
PB: Yes, I think that is absolutely correct. The capturing of real-world experiences via digital can only enrich the amount of information at our disposal. It allows us to capture a broad range of representative, patient subsets, which would not typically be achievable through an RCT.
In your opinion, does social media allow you to find more ‘real’ patients?
SR: Yes, because we are using a much more inclusive methodology, we are more likely to gather evidence that reflects real world use.
PB: Yes, digital and social media allows us to target and engage a wide range of patients in the real world. The proprietary digital technologies we have developed are then key to ensuring that we capture data quickly and efficiently from our target patients. Without this unique capability, that we have developed over twenty years of working in digital healthcare, the methodology would not be viable.
Which particular area of research are you particularly excited about that DWE can delve into that conventional research can’t?
SR: There exists a real tension between self-care advice given on the one hand by NHS choices and organisations such as the PAGB and the scepticism within the medical literature published in leading journals, such as the British Medical Journal and The British Journal of General Practice. A good example is cough mixtures, where from a Public Health perspective we want to advocate self-care, however clinicians don’t have an evidence base to back up any recommendations. It’s highly unlikely that pharmaceutical companies would be prepared to invest in a costly randomised control study, however, a well-structured real-world evidence study could provide compelling evidence regarding the efficacy of an over-the-counter product, so facilitating its use through professional recommendation.
PB: The opportunities are wide and significant. If we can provide a greater depth of research, so that patients and healthcare professionals can make better, more informed decisions about products, treatments or medtech, that will be a tremendously exciting transformation to the healthcare industry, that our team at Orbital Research can be truly proud of.
Data collection isn’t governed by clinical trial regulations – what do you feel are the pros and cons?
SR: It boils down to those designing real-world evidence studies needing to behave very professionally, and to use expert panels in the design stage of a study to mitigate risk and promote high-quality research.
PB: The unique Digital Real World Evidence service that we have pioneered, is delivered to the highest medical research standards. Peer review ensures that any research findings are robust and credible. It is our intention that all research conducted in this way, will be held to the highest possible standards.
The white paper in IPI Technology says: “The method of real-world data collection using social media is ideally suited for consumer brands…” Is it well suited for B2B medtech/life science manufacturers?
SR: I attended the Wearable Technology show in London recently. I was inspired by the technology discussed, and the passion and inventiveness of the presenters. This needs to be matched with evidence relating to the impact of these technologies. Good evidence leads to good choices for those designing health systems and consumers wanting to purchase the most effective products.
PB: Yes. I believe that the Digital Real World Evidence methodology will find many invaluable uses, in these areas.
