Don’t fall at the last hurdle: drugs are only as strong as your clinical trial data

By Paul Acton, SAS Ireland

There’s been a lot of talk about pharma M&A recently, with Pfizer’s failed takeover bid for AstraZeneca taking up most of the column inches. GSK and Novartis announced a major commercial tie-up; while, closer to home, ICON completed its acquisition of Aptiv Solutions.

This changing landscape is exciting news for the pharma industry. But, as clinical trial data is the pulse of any life sciences company, it’s imperative they give serious thought to how to integrate their huge data repositories, standardise, and ensure data quality. With risks including drugs not making it to market, delays and litigation, the financial and reputational risks of not doing so are high.

Of course, it’s not just acquisitive companies that need to think about the challenges around data integration. Every life sciences organisation must be able to answer tough questions from regulators and auditors, not to mention the public. So it’s imperative to manage and integrate data from across the whole of R&D: from drug discovery to real-world use.

A recent example of the importance of data integration is the flu drug Tamiflu, which made the headlines in the UK after a report by The Cochrane Collaboration questioned its efficacy. The claims came after Cochrane reviewed all the trial data, rather than just the publicly available clinical study reports (CSRs). There was no suggestion that Tamiflu manufacturer Roche had done anything wrong; it's legal, common practice to leave data out of CSRs for any number of reasons. And the debate over the validity of Cochrane’s report continues.

Yet questions were raised around why it was so difficult and time-consuming for Cochrane to find and interpret the missing data; files were in disparate locations, while data was incomplete and unstandardised. Again, this is not unusual. But it could have been avoided if all the data were integrated, cleaned and readily available when needed.

The good news is that data integration doesn’t have to be a major undertaking. SAS® Clinical Data Integration organises, standardises and manages clinical trial data from multiple sources to give life sciences organisations consistent, trusted and verifiable clinical information.

Plus, better data integration can lead to enormous benefits, beyond regulatory compliance or research validation, such as providing a platform for big data analytics. McKinsey found that better use of big data could help pharma better identify potential drug candidates and develop them into effective, approved and profitable medicines more quickly.

And it names data integration as the first step in that journey: “Effective end-to-end data integration establishes an authoritative source for all pieces of information and accurately links disparate data regardless of the source – be it internal or external, proprietary or publicly available.”

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