PharmaTimes talks to Elaine Irving on the merits of real-world evidence and her role as GSK’s senior director & head of Real-World Study Delivery

What is your background and current role?

I am head of Real-World Study Delivery at GSK. Real-world data is data collected about a patient gathered during their everyday care. Real-world evidence is derived from this data through the application of scientific research methods. GSK uses multiple types of study approaches to generate real-world evidence. I lead a group of researchers focused on the implementation of clinical studies conducted in the routine care setting.

We aim to answer questions that conventional randomised controlled trials (RCTs) may not be able to, such as how a medicine behaves in patients with more than one medical condition, or if a patient forgets to take it when they should. This helps us better understand the effectiveness of our medicines when taken as part of a patient’s daily care rather than a clinical trial.

I have over 20 years’ drug discovery and development experience leading multiple early clinical development programmes. I studied pharmacology and have a PhD in neurodegenerative research.

What drives your passion for your area of work?

Getting regulatory approval for a medicine is a huge achievement, but there are many challenges beyond that point. The trials that support approval can’t always answer all the questions decision-makers have when assessing the value of our medicines compared to existing therapies.

I’m passionate about the design and delivery of studies that bridge the gap, providing information to help doctors make more informed decisions about treatment options and, ultimately, ensure patients can access the medicines they need.

What does your day-to-day work involve?

Conducting research within a routine care setting requires minimal intervention in patients’ lives and minimising burden on doctors. My team develops novel ways of capturing data during patients’ routine appointments and their everyday activities, such as electronic health records, apps and devices. Every study is different and has its own operational challenges which involve multiple brains to solve. Thankfully, my fantastic team thrives on problem-solving!

Can you outline the promise of real-world studies for medicines development?

RCTs are considered the ‘gold standard’ of evidence-based medicine. Through standardisation and blinding they deliver data to determine if a medicine’s benefit/risk profile supports its regulatory approval.

Real-world studies aren’t a replacement for RCTs as their design can’t always account for bias or confounding factors. However, they can provide complementary information on a medicine’s effect when used in routine care, in more heterogeneous patient populations, or with less standardised treatment protocols. This can help decision-makers assess the value and impact on healthcare systems.

What are the key challenges for pharma companies wanting to increase use of large real-world studies in their R&D?

While regulators and payers seek to understand how real-world evidence can support decision-making there is no clear guidance on how it should be generated or what decisions it can impact yet.

There’s also a lack of guidance on assessing the quality of data sources or methods for managing bias. Large-scale real-world studies can be costly and complex to run, so uncertainty around their impact deters a lot of other companies.

This is a big focus area for the Innovative Medicines Initiative (IMI) ‘GetReal’ Initiative which I lead. We’re trying to seek agreement between stakeholders on optimal analytical approaches and bring transparency and consistency to the methods used.

What are the key challenges of conducting RW studies in the respiratory space in particular?

The specific measures that determine a respiratory medicine’s effect, for example exacerbation rates or lung function, can be difficult to extract from electronic health records resulting in a need to conduct a study specifically designed to collect this information. Although they’re challenging, we think it’s particularly important to conduct real-world studies in respiratory. We estimate as few as 7% of COPD patients and 3% of asthma patients are eligible for traditional RCTs. Factors like age, smoking history or the presence of other illnesses mean most patients won’t meet the enrolment criteria. Our studies can help show how the effect of our medicines seen in RCTs translate into the overall patient population.

How have learnings from the pioneering Salford Lung Study been applied to current research?

The Salford Lung Study (SLS) was a world-first, using integrated electronic medical records to monitor patients remotely so they could continue their daily lives whilst participating in research. Although they have different designs, SLS paved the way for our research today. Since Salford, we have found ways of expanding our data collection so instead of taking place in one city, today’s studies are being conducted across multiple treatment centres and countries across the globe.

Can you summarise findings of the REALITI-A trial and what they might mean for the field?

REALITI-A is a real-world study in patients with severe eosinophilic asthma. It is exploring our biologic treatment mepolizumab in a routine care setting, looking primarily at its effect on the rate of exacerbations (asthma attacks or flare-ups) patients’ experience before and after starting treatment. Exacerbations are devastating events for patients, so reducing them is a key treatment goal.

The study’s ongoing but interim results show that, compared to the year before patients started mepolizumab, after 12 months of treatment there was a significant reduction in the rate of exacerbations, and oral corticosteroid use. Safety results are consistent with previous studies. While these are interim results, they’re encouraging and show the potential impact on patients’ everyday lives. We’re looking forward to the study completing in 2021.

What do you see as the key recent advances in the field?

We can now collect information from electronic health records, apps and wearable devices in a way that we couldn’t a few years ago. In REALITI-A we are using a ‘bring your own device’ strategy that allows patients to download a smartphone app to capture, record and transmit data. This lets us capture a broad range of information with minimal study-related interaction with patients, allowing them to continue their daily routine.

Overall, what do you think could have the most impact on improving pharma R&D success rates?

Developing medicines is challenging and the percentage that finally reach the patient is very small. To increase our probability of success, at GSK we follow the science and look for the best opportunities to help the greatest number of people, regardless of therapy area or modality. This means being guided by science and data, so evidence generation is as critical as ever. Data will help us take smart decisions, focusing on medicines that show the greatest potential for success and terminating assets where results don’t support progress. This frees resource for other R&D opportunities that will hopefully translate into medicines that make a difference to patients where there is high unmet need.

What are your passions outside of work?

I’m married with two girls, aged 11 and 15. Most of my life revolves around running them to different sporting activities. I spend my life at the side of a netball, hockey or tennis court/pitch.

If you could invite anyone (alive or dead) over for dinner, who would it be and why?

George Clooney! I’m sure my reasons are pretty clear!