The End of Paper?
Paperless clinical trials have gained momentum but what barriers need to be cleared before we say goodbye to paper forever?
Paperless clinical trials offer so many benefits over traditional paper-based processes that a recent survey of those involved in pharma drug development
placed the importance of going paperless as 4.2 out of 5.
However, the survey – carried out by SCORR Marketing alongside Applied Clinical Trials – also showed that adoption of paperless processes has been inconsistent. While a quarter of clinical trial ‘users’ reported that three-quarters of their data collection was paperless, another quarter reported that less than 20 percent of their processes had done away with paper.
One GCP data integrity expert at a major European pharmaceutical company who wished to remain anonymous – and a self-confessed evangelist of paperless technologies – has run a series of pilots using eSource. “We wanted the paperless clinical trial, where, instead of being transcribed from a piece of paper collected during a site visit, data was directly entered into a system,” he says.
He sees two major drivers of the trend to paperless. The first is the rapid pace of technology: “I witnessed the move from fully paper-based trials to electronic data capture (EDC) but the promise of eliminating paper was never fully realized. However, with electronic record systems in hospitals, ubiquitous broadband wireless not just in hospitals and sites but in patient homes, and mobile technology and apps, it is looking possible.”
You do not have the ability to detect things that might be foreseen or happening with the drug as early as you do with electronic devices.
The second driver is a heightened focus from regulators on data integrity. “If you look at the observations made by regulators such as the FDA and EMA during clinical site inspections, some of the highest frequency are problems with the source. They can’t find the source, data has been backdated, data is missing, data is not legible,” he says.
Tom O’Leary, Chief Information Officer at drug development service company ICON, is even more outspoken about the inefficiencies of paper-based processes. “With paper, the biggest problems are the time it takes to gather the data and the transcription errors that take place. For the longest time, all clinical trials used paper, where the time from patient assessment at the physician’s office to the data being analyzed was weeks, if not months.”
The slow pace of the paper trail meant errors or oversights weren’t picked up quickly, he says. “You do not have the ability to detect things that might be foreseen or happening with the drug as early as you do with electronic devices.”
Fear of change
Those involved in the shift to paperless have seen a range of issues arising – concerns over data security (29 percent) and data quality (13 percent) and worse external collaborations (9 percent) – although just over a quarter experienced no problems at all (27 percent), according to the SCORR survey.
The anonymous data integrity expert admits that it won’t to be a smooth transition. “When you add technology, you need to navigate a learning curve; the human animal does not always respond well to change and the regulators feel the same way. A lot of handholding is needed when you change a well-worn process.”
He describes an understandable ‘not my trial’ attitude that pervades pharma culture. “If you introduce something new, where the process is not totally defined, you are introducing risk to a team’s objectives. Until we get the metrics together and get our studies locked down, that attitude will remain.”
Indeed, the SCORR survey found that ‘fear of change’ and ‘lack of interest’ were key factors hindering paperless, although the largest issue was the cost of the technology (40 percent of respondents).
The anonymous researcher, whose company has completed phase I paperless trials and has moved to phase II, III and IV, says lessons learned include the need for buy-in from management and ensuring you use the right supplier. “These systems must be well-validated and well-supported. As a pharmaceutical sponsor, you can’t also host the data yourself, you are not even allowed to see the source data. Well-written and clearly understandable standard operating procedures and working practices are essential.”
He sees his job as a ‘fixer’ who reacts to problems as they arise. “Any quality issue, no matter how small or insignificant, will not instill or maintain confidence in the new technologies,” he says.
Up in the cloud
A leader in the field of paperless trials is mHealth solutions provider, Medidata, whose president and co-founder, Glen de Vries, well remembers the bad old days. “These bits of physical paper moving around, I was one of the people who did it. We did a good job of being compliant and responsible and as transparent as you can be when you are depending on pieces of paper in a big clinical trial that could be sitting in 50 different countries and a couple of hundred doctors’ offices,” he says.
De Vries also worked as a research scientist in Columbia Presbyterian Medical Center, with “stacks of laptops” for a single trial. “The technology was put on top of the clinical trial – each piece of software was loaded on to a different laptop,” he says.
Although he agrees that there is a mindset problem, he is keen to emphasize the pioneering work being done to address regulatory compliance issues in different jurisdictions, which can vary considerably. “We must have an underlying understanding of and practical ways to address legislative and regulatory environments so we can take advantage of the technology,” he says, citing a data center the company recently opened in Germany specifically to meet legislative data requirements.
To ensure data quality, Medidata employs machine learning algorithms to inspect data in real-time for quality or accuracy issues. “The people who wrote [the algorithm] used to be data reviewers at the FDA. We are trying to help people think in new ways by bringing in industry people who know how it works. The level of transparency and reliability and quality you can get around data in an electronic clinical trial far exceeds that in paper clinical trials,” he says.
If you look at the key performance indicators in a clinical trial – such as the cost, how hard it is to do – our clients are achieving 30, 40, as much as 60 percent improvement versus paper or another electronic platform. You can make clinical trials faster, cheaper and better quality – you can accomplish all three.
Cloud-based solutions can also keep track of any changes to the data, removing any data integrity questions, he says. “Our cloud shows when anyone interacts with a piece of data to do with a clinical trial wherever they are in the world, whether they are entering or reviewing it or changing it, that is something that is not only comforting to our clients, it is comforting to regulators as well.”
Paperless technologies are having positive impacts on trials and how they are run, says de Vries. “If you look at the key performance indicators in a clinical trial – such as the cost, how hard it is to do – our clients are achieving 30, 40, as much as 60 percent improvement versus paper or another electronic platform. You can make clinical trials faster, cheaper and better quality – you can accomplish all three.”
For the anonymous data integrity expert, we live in very exciting times. “There is a lot of activity and a lot of adventure in clinical trials right now, even though it is such a conservative industry. We may be slow to adopt but the imagination can run wild, with an eye on proper validation and qualification of systems. I will pop the cork on a bottle of champagne the day the first truly paperless trial happens.”
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