Three Questions on Data Management in Pharma

Pharma amasses volumes of data. But with a lack of uniform practices among industry players, it can be difficult to ascertain what good data management looks like. At this year’s Veeva Summit for R&D and Quality, we spoke to Richard Young, Vice-president of Vault CDMS at Veeva, about best practices.

Many industries have already embraced paperless systems. Why has it taken pharma so long to do the same?
 

The pharmaceutical industry can be very conservative. Consider the industry’s adoption of electronic data capture (EDC)  systems as one example; the first electronic records were first used in the 1970s by AstraZeneca. However, it took another 40 years for 50 percent of studies to shift to the use of EDC. 

Today, technology advancements are happening at an incredibly fast pace and companies will have to get used to the idea that there will be new models to embrace and adopt every 2-3 years. There will always be a better way of doing things and companies today can’t afford to buy a system with the hope that it will work for them unchanged for 10 to 20 years. 

It will be interesting to see how they react. But the growing volume of data we have will certainly play a key role in their response and choices when it comes to the adoption of new technologies.

Does there need to be a harmonization of practices when it comes to data management?
 

Absolutely. I think that data transparency acts and other initiatives that allow us to share data are vital. In recent years, there’s been a shift in the industry to determine what intellectual property is and isn’t, and companies are now more willing to share data, which would have previously been shrouded in secrecy.

Studies like I-SPY-2, a clinical trial developed to improve outcomes for breast cancer patients, have helped show that a different kind of research is possible within industry spheres. I-SPY-2  created an environment for clinical trials, whereby the real tie accumulation of clinical data, coupled with broad range demographics and medical history, altered the treatment options for future patients. It demonstrated that a much more aggressive form of clinical research could and in fact would accelerate the delivery of long-term treatments for patients, and that the key was the rapid use of data for real time decision making. Simply put, collaboration is helping to drive progress. The COVID-19 pandemic has also spurred more cross-industry partnerships than ever before and I think this attitude will stick. 

However, the industry needs to take a long hard look at its data standards, which are currently lacking. I can only estimate the amount of time, effort, and money we waste trying to reconfigure data that has no benefit. With decades worth of evidence highlighting the importance of clear, transparent data management, the industry should have already had these conversations and established robust guidelines. For example, in some countries, there are still questions about whether wet ink signatures are a requirement for trials when e-Consent platforms are available. If one company or industry group stands up and develops a model, the rest of us should be able to follow it. However, in my view, regulators need to come together with pharma and technology to drive this. 

At Veeva, we engage in regular dialog with regulatory agencies. What we have seen – particularly in the US – is that the discussion is evolving. A few years back, regulators would dictate what we would do with our data, but now they ask the industry about approaches and the benefits. So rather than being dictated to, we are briefing these agencies and establishing a different type of relationship. The fact that they are listening and developing positional papers on the subject is positive. 

We have contributed to a number of industry think tanks, as well as published several position papers of our own to help add to the conversation.But it’s essential that others respond to these types of resources. We don’t necessarily have to agree, but the conversation will be more dynamic and meaningful when more voices contribute to it.

What must the industry do now?
 

I think we have to be open-minded. For example, we’ve seen GSK and Roche come together to develop a crowdsourced group called, ADMIRAL. The initiative is helping companies manage the raw data that ultimately helps contribute to a submission. Trawling through these databases can often be a painful process, but this program could help the rest of the industry to better manage it. I love the fact that two companies are investing time and resources toward developing something where everyone – not just its developers – stands to gain. 

It would be a shame for other companies not to look into this. Though they may choose to reject it, the most important thing they can do is engage with others so that we can continue to see progress within the industry.