In randomised control trials (RCTs), the acknowledged backbone of the Pharmaceutical Industry, populations of patients are carefully selected and homogenised in one or several respects to minimise allocation bias, and are then treated separately in one aspect of their treatment to monitor results.
In this way we can produce meaningful statistical insight into responses to treatment, medications, or service support. It’s a sound scientific method, and widely considered the ‘gold standard’ for the pharmaceutical industry.
But in the real world, ordinary patients are influenced outwith the scope of RCTs by genomic makeup, lifestyles, habits, diet & environment. So it’s no surprise that the results of an RCT may not translate into the real world as efficiently as would be hoped for.
Real world data offers the opportunity to add deep insight across specific cohorts of populations, augmenting RCTs, helping tailor medicine solutions and driving improved patient outcomes. Real world data allows us to see how specific treatment protocols affect people of different age, gender, ethnicity and beliefs – across wide ranges of co-morbidities and co-meds behaviour.
Increasingly importantly, real world data can be gathered economically as part of a continuous ongoing engagement with the patient, giving healthcare consumers a real ‘voice’ in their care service delivery.
However, you can have too much of a good thing. There has been a revolution in the last 10 years in how, and how much, real world data can be acquired. There are 3.5 Billion of us now interacting with the Internet. Various reports site that over 90% of the world’s history of data has been generated in just the last 2 years. Fit bits, smart phones, apps, heart monitors, trackers, EPRs, insurance databases, national data sets, medical devices and more add countless gigabytes of ‘health data’ daily.
The boundaries between medical care, and digital care are merging. The FDA recently announced that it has approved the world’s first ‘digital pill’ from Otsuka which (literally) tracks adherence to medicines, and feeds back compliance data via a digitally enhanced dermal patch.
It’s a digital tsunami of real world data of various quality, compatability, verifiability, transferability and, indeed usefulness. But the demand is there. In a study recently commissioned by eyeforpharma ‘86% of PharmaCo agree they need more Real World Data on why medicines are/aren’t taken by patients’ – and it’s no surprise.
With a lack of new molecules, PharmaCo are increasingly fighting for market share for their branded, ethical and even generic medicines. New payer models are emerging from national healthcare providers and insurance payers based upon patient outcomes, rather than a race to the bottom on cost per pill.
Even today we are only at the tip of the transformational iceberg. ‘Properly analysed real world data can provide key insights that will help drive down medical costs, as well as improve both product safety and effectiveness.’
Regulators too are welcoming the additional, long term insight that real world data can bring post launch of a new medicine.
‘Pharmaceutical and medical device companies must now demonstrate evidence of successful real world outcomes to differentiate their products in a saturated and competitive environment, while also satisfying the additional scrutiny and demands of regulators, insurance companies, healthcare providers, and individuals to whom the products will be prescribed.’
By applying specific real world data questions and medical context to cohorts of interest, the outputs of real world data can be transformed into clinically relevant and useful, real world evidence.
The Academy of Medical Sciences, together with the Association of British Pharmaceutical Industries, recognise the challenges and opportunities that Real World Evidence, derived by the analysis of real world data, represents –
‘Real world evidence offers a complementary resource, or in some cases even an alternative, to the evidence generated by randomised controlled trials. Such evidence can enhance the evaluation of the safety and effectiveness of medicines for the benefit of patients, allowing treatments to be better tailored, tracked and understood for each individual.’
Some would say that real world data support for pharmaCo, medical device & service deliverers is becoming ‘the new norm’.
‘Proving safety and efficacy through an RCT prior to product launch is no longer enough to guarantee success and profitability in an increasingly competitive healthcare environment. Pharmaceutical and device companies must now demonstrate evidence of successful real world (data) outcomes to differentiate their products in a saturated and competitive environment, while also satisfying the additional scrutiny and demands of regulators, insurance companies, healthcare providers, and individuals to whom the products will be prescribed.’
As the amount, and way in which we handle real world data grows, real world studies are emerging with significant scale and the potential to determine how new drugs may perform beyond the scope of RCTs. By blending a number of real word data, and traditional data sources and mining with Artificial Intelligence, data analytics are providing the key to faster, more effective medicines solutions.
‘Real world evidence has the potential to greatly improve and accelerate the development and delivery of safe and cost-effective innovative medicines to patients and how we approach health and healthcare’
Regulators and manufacturers are embracing real world data’s ability to add valuable insight to RCTs, and using real world data to provide evidence of how a drug is actually used in the wild.
It is to be hoped that as real world data is more widely accepted as ethically acceptable care evidence, that we can rapidly and significantly transform the way healthcare is delivered around the world, giving more accurate predictors of health outcomes, reducing costs, and improving personalized medical care and welfare for all.