Henrik Nakskov from NNIT discusses the importance of data integrity when you make clinical trials data mobile.
Gaining increased mobility has long been a goal of medical professionals and trial sponsors alike. Mobility holds promises of enhanced efficiency and may drive growth, but it also brings its own set of challenges that must be addressed. If we look at clinical trials, information is highly sensitive and subject to strict processes of validation. When you mobilise clinical trials data, medical professionals need to be able to have unconditional faith in the figures. The consequences of making a decision on a non-validated data foundation can be fatal – in terms of patient safety, and in terms of operational and financial jeopardy for companies developing drugs. Hence, the same strict regimen needs to be persevered in mobility in order to maintain the data credibility.
According to Henrik Nakskov, life science industry expert at NNIT, there are four areas the life science business must deal with in the process of going mobile:
In a previous article, ‘CDISC implementation is key to optimised clinical trials’, Nakskov presented how data standardisation is the necessary response to data growth. This article pursues standardisation and data management as a prerequisite to ensure data integrity in mobile data.
In an area as unpredictable as clinical trials, one can never guess how a single change can affect an entire system. As the trial process gets more complex and the number of variables increases, understanding causality, designing adequate processes and finding a way of mobilising the important pieces of data, at any time and through any mode, becomes vital.
For sponsors, who are held responsible if something goes wrong, data integrity is very much a matter of urgency. Also, they are not in a position to continuously monitor all the data associated with a trial. They want to be able to extract the most important information from a vast pool of dynamic data. “Safety considerations mean that data monitoring is a very big part of clinical trials today,” Nakskov explains. “Sponsors travel a lot and are increasingly eager to get the conclusive data on the fly – especially the deviant data, which is why signal detection and alerts when data deviate from the expected must be prioritised."
Being able to trust in data is also contingent on proper data management and the employment of metadata and master data governance. This method is widely adopted and allows you to track a data element all the way from the origin through to the receiver. “We view metadata and master data as tools, not just theory,” says Nakskov. “Each time a data element goes from one part of the chain to another, we attach metadata. This tells you where the data has come from and which processes it has been through. “It may seem ironic that in order to control the amount of sensitive data, more data is added. But it is the only way to ensure the integrity of data and allow increased mobility,” says Nakskov. “However, the problem with metadata and master data is that many companies don’t have a unified DM governance for all systems, so you may enrich with metadata and master data, but differently within each system. As a consequence, data integrity is at stake. This once again takes us back to the issue of standardisation – quite simply, there is no short cut if you want to be able to trust mobile data”. Apart from employing metadata and master data governance, companies as a minimum must consider:
Although it may seem simple to allow the exchange of data between people and systems or visualise data in an app, the back-end complexity is enormous. To achieve success in mobility, this complexity must be addressed directly: look at the back-end integrations, establish standards and processes, employ metadata and master data governance, align mobility strategy with corporate strategy and, first and foremost, ask yourself, ‘how do we wish to work and what does it take process and IT-wise to be compliant doing so?’. Then you will be able to mobilise the vital data and the people working with the data can have justified faith in the figures and solid grounds for making qualified decisions anywhere. This is the essence of mobility.