How digital real world evidence is shifting the landscape of clinical trials

Digital Real World Evidence is a new and exciting methodology, offering huge benefits to the healthcare industry. Peter Brady, CEO of Orbital Media, pioneers of the concept, discusses its potential to save the industry billions of pounds.

Thirty-eight million people in the UK actively use social media, and 50% of the population actively use their smartphones to access their Facebook, Twitter, and Instagram accounts. For the first time, these platforms can provide a frictionless pathway for engaging relevant patients in research, that produces high quality and robust healthcare data. Orbital Media has broken new ground in developing this methodology as a viable way of collecting valuable Real World Evidence insights, that healthcare companies can use in a variety ways. For instance, long established licensed medicine brands can strengthen existing product claims or develop new ones, saving millions of pounds on risky, randomised clinical trials.

Dubbed ‘Digital RWE’, this innovative, award-winning and peer reviewed methodology could be transformational for the healthcare industry. Beyond product claim generation it has the potential for deployment in new product development research, label comprehension studies, public healthcare procurement and brand messaging research, all of which have the potential to create billions of pounds in value!

The opportunity for this methodology is further highlighted by the growing clamour for healthcare brands to provide up to date, credible evidence, to support their licensed product indications, claims and general product safety, throughout a product’s lifecycle. This is backed by the Association of 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’¹.

Historically, healthcare brands have relied upon repeating Randomised Clinical Trials (RCTs) to support their product licensed indications and claims. In addition to being expensive and time-consuming, RCTs have another major drawback: they are a snapshot in time of highly selected populations, treated for typically unrepresented short periods of their lives. They demand inclusion and exclusion criteria to sharpen the precision of the questions they ask, are typically age-restricted, and only rarely include the full gamut of medication and treatments that a real patient might be taking.

Supports licensed indications, pattern of use and outcomes based on real life experience

Taking this into account, RCTS are not representative of what happens in real, everyday situations. What is needed as an addition to this, is information about what happens when a medicine is being used in the real world – the world where doctors and patients in the marketplace are actually using a medicine. Patients may not read the instructions or take it as it was intended – not using it frequently enough, taking incorrect dosages or not taking it at the correct times. There may be confounding issues that were not envisioned in the clinical trials, such as unusual diets, use of additional alternative therapies, taking the drug continuously for a long time, being outside the age range that was tested in clinical trials, or taking it alongside other prescribed medicines which were not part of the original studies.

Digital RWE 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.

Research can take place in areas of conventional healthcare that would traditionally be difficult or not possible, for example, the societal impact of conditions which might not generate a doctor’s visit (e.g. nappy rash, or other minor skin ailments), or the use of healthcare products in babies.

It also 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. Pharma studies using this new RWE solution have been peer-reviewed and published, leading to new promotional claims being accepted by regulators, including the ABPI[1], PAGB,[2] and MHRA.[3]

How it works

Large numbers of participants are recruited via digital and social media, with high levels of data harvested, for a tiny fraction of the cost and time of an RCT – a digital RWE study costs just a tenth in comparison. It is also a much quicker process, with studies being conducted in a matter of three or four weeks, and the entire process, from the start to the publication of peer-reviewed papers, taking approximately four to six months.

The source data is collected via digital and social media channels, which is then collated, analysed by an experienced medical research team, and sent for publication in journals as academic papers. 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.

We have employed this new method recently for two of TEVA Pharmaceuticals’ infant brands: Infacol and Sudocrem Antiseptic Healing Cream. As a result, both brands now have new and strengthened product claims, approved by the PAGB, which can be deployed within marketing activity. Interest in digital RWE is rapidly building across the industry and we are now rolling out a programme of project activations across the industry.

Digital RWE studies have proven to be a rapid, inexpensive way of conducting research, and provide data that may add to the value of promotional claims, reinforce licensed indications and patterns of use, and may also assist with price justification. This unique methodology could have a seismic impact on the healthcare market, creating up to an estimated £1 billion in value over five years, via new and improved product marketing claims and saved clinical trial costs – a figure which could easily rise as the methodology is developed further.

Orbital Media is currently the only operator in the market place, offering this unique, award-winning service. For more information visit

[1] Association of The British Pharmaceutical Industry

[2] Proprietary Association of Great Britain

[3] Medicines and Healthcare Products Regulatory Agency


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