What is your background?
I originally qualified as a chartered surveyor, however, my career path took a very different direction because of my passion for digital technology. I have nearly 20 years’ experience within the digital and social media sphere, having taught myself code and been an early adopter of blogging back in 1999. This passion led me to become a tech innovator and digital marketer, and to my current role as Chief Executive Officer for Orbital Media, one of the UK’s most innovative full service digital agencies. I have written extensively about tech, digital and social media, in a variety of white papers and publications over the years and am a regular keynote speaker on these subjects.
What is the history of Orbital Media?
Orbital Media was established in 2003, borne out of a strong desire to pioneer the development and use of new technologies. The company has over 15 years’ experience, specialising in developing the latest technology, digital marketing strategies and award-winning campaigns. We have particularly focused on pioneering innovations utilising technologies such as virtual reality, artificial intelligence, augmented reality and gamification. One of our most recent award-winning innovations is Real World Evidence via Digital and Social Media.
What is Real World Evidence via Digital and Social Media?
Healthcare brands are increasingly under pressure to provide up-to-date, credible evidence to support their product’s licensed indications and claims, throughout a product’s life cycle. This is backed by the Association of The British Pharmaceutical Industry (ABPI) in its white paper, citing the growing number of examples where Real World Evidence (RWE) has been ‘essential for the market access of a product’. Until now, there has been no systematic collection of data from non-prescription healthcare interventions, leaving these brands with the only option of repeating expensive and time-consuming randomised clinical trials (RCTs).
RWE via Digital and Social Media is a new, versatile and peer-reviewed RWE collection methodology, which sources data via social and digital media platforms, based on what actually is happening or has happened in the real world. The data is then collated, analysed and published in journals as academic papers. Pharma studies using this new RWE solution have been peer-reviewed and published, leading to new promotional claims being accepted by organisations such as the PAGB and MHRA.
TEVA Pharmaceuticals has used this new method recently for two of their infant brands: Infacol and Sudocrem. As a result, both brands are now able to use new/strengthened product claims, which were approved by the PAGB.
What advantages does it bring over traditional evidence, or even other forms of RWE?
RWE via Digital and Social Media delivers a number of benefits. First of all, it is a low-cost solution in comparison to Randomised Clinical Trials (RCTS); often up to a tenth of the cost. It is also a much quicker process, with data collection being conducted in a matter of three or four weeks, whilst the entire process up to the publication of a peer-reviewed paper taking approximately four to six months. Despite this, it can collect data on a large scale, with high levels of detail.
Whilst controlled clinical trials are the ‘gold standard’, they are often rigid with enforced rules, and represent a limited snapshot of a healthcare intervention, even if patient-reported outcomes are included. There are also stringent inclusion and exclusion criteria, making it possible to recruit the patients most likely to respond to a treatment (which may suggest an intervention is more effective than might be experienced in real life). RWE seeks to portray outcomes when doctors and real patients in the marketplace use a medicine. They may not take it as it was intended – under or overdosing, taking it when they feel like it, or even crushing tablets and washing them down with alcohol. RWE via Digital and Social Media reflects exactly what is happening when real people take the medicine in the real world. What’s more, the data collection is not governed by clinical trial regulations, giving companies greater control.
Studies can be conducted in areas where conventional healthcare research is not possible or difficult, such as the use of healthcare products in babies, and the societal impact of conditions which might not generate a doctor visit, e.g. nappy rash or other minor skin ailments.
Finally, it allows for repeat data collection, to confirm validity and add to the baseline information, as well as using the evidence for substantiation of claims and rejuvenation of branding.
How is this data gathered?
RWE via Digital and Social Media utilises a collaborative approach between Orbital Media’s system for collecting and collating data via digital and social media channels, with an experienced medical research team. A formal protocol must first be established between the pharma company and the medical advisor. We then consult with key opinion leaders to confirm the study’s approach and identify routes to recruiting participants, e.g. via social media and digital channels. Following this consultation with the medical research team, a bespoke study is designed and launched, preceded with a pilot phase to iron out any potential issues. The process incorporates exhaustive cross-checks, data filtering and cleaning of data, to ensure that any conclusions drawn are robust enough for submission into a peer-reviewed academic paper. For example, users may be rejected from the study if they are answering in a way that indicates a rushed approach.
The data sought very much depends on the type of healthcare product that is under review, and any claims that the company wants to develop or strengthen. The result is a reservoir of high grade data which is reviewed, analysed and is subsequently formulated into a final study for publication.
What challenges are there in collecting and analysing digital RWE?
Our main challenge is to ensure that the data collected is high-grade and robust enough for a peer-reviewed academic paper. This means that during the process, we undertake data filtering, cleaning of data and many cross-checks,. For example, users may be rejected from the study if they are answering in a way that would suggest they are trying to rush through it.
What disadvantages does data from digital and social media have over other forms of evidence?
We have to take into account potential responder bias, due to targeting patients and communities with a known interest in a particular disease or treatment and make this transparent in any report or data use. RWE via Digital and Social Media also depends on respondents having access to social media. Therefore, this method instantly disenfranchises those who do not have computer access, the computer illiterate, the very elderly and those too disabled to use social or digital media.
How would you like to see the area developed in the future?
I am immensely excited by the promise that RWE via Digital and Social Media holds for the pharma industry. It is not yet a complete substitute for RCTs, rather an adjunct support for existing clinical trials. However, the potential to develop the methodology further, into a variety of areas, could mean billions of euros worth of value created over the next five years. That is an invigorating and potentially disruptive prospect for the healthcare industry.
