Collecting data during clinical trials and within the laboratory environment is a time-consuming and laborious task. When trial or analysis is being conducted across the globe, and on thousands of subjects, it is a logistical nightmare where costs run into millions.
Researchers are now fixed on looking for ways to ease data collection and storage, while ensuring quality results and making this form of research a priority. To push this process forward, the world's experts are meeting at Munich in June during VIB's Laboratory Data Management conference. The focus is now on making research information easy to input and allowing multiple departments to access one another’s work.
Moving towards a paperless lab, however, has its challenges. Technical and semantic challenges still dominate controversial attempts to electronically store hospital patients' records, for example. But in the drug-development stage, a hybrid technology is now helping researchers to collate patient records and immediately share findings with colleagues around the world.
A Switzerland-based research firm, Actelion Pharmaceuticals, is pioneering the use of digital pen and paper technology in its laboratories around the world. Natalie Coomber caught up with head of systems development for biometry Massimo Raineri to find out how Actelion is using this technology to collect results on its in-house case report forms (CRFs) used to record patient findings.
Natalie Coomber: How does the digital pen and paper technology work?
Massimo Raineri: The technology has two parts. Firstly, in addition to having ink the pen also has an infra-red camera, a sensor and memory device installed in it. The second part of the technology is a way of covering normal paper with a random grid of small dots to form a unique pattern. While you write the camera is taking snapshots of the pen's exact position to the paper.
It also records the time and date in the same way as a very precise global positioning system.
A company called Anoto holds the licence for both the pen and the paper – for which you buy a section of the patent. Each CRF has a unique grid pattern on it and the pen writes in exactly the same way as a conventional device. Once you have finished, you transmit the data to a server.
NC: Are there any security issues with transmitting patient data across the internet?
MR: Our company uses a USB connection to upload the data, although you can use Bluetooth. Sending data across the internet is, of course, a very delicate matter but the pen and paper are encrypted.
Even if you could lift the data from the pen all you would see is a long list of grid coordinates because the layout of the form on which you are writing is not transmitted. Only by having the background and the results is it possible to recreate the full information.
NC: At which stages of the clinical trial do you most commonly use the digital pen, and why do you find it so useful?
MR: We mainly use it in phase II and phase VI, and in some cases phase I. The main advantage is that these are long trials, happening all over the world so having the data as soon as possible is very important.
It is useful because it gives the benefits of both paper collection and electronic data collection (EDC).
The advantage of EDC is that the sponsor gets the data quickly but the investigators are not always willing to retype findings into the computer because it is not their job.
NC: Are researchers more comfortable recording data in front of the patient by pen as opposed to typing information?
MR: The advantage of paper is that everyone is familiar with it and you can write while looking in the eye of the patient. The real problem is that researchers don't use anything in front of the patient – EDC or pen and paper. But, when they have to use something paper is much more natural than using a computer, for the researchers and the patient. The perception of the patient is that if you are typing you are neglecting them.
NC: Where in the world is the digital pen and paper being used the most?
MR: We are using it for clinical trials in the US, the Middle East, Asia and Europe. I think from a user point of view it is most popular in the Far East, and this is not just restricted to its use in clinical trials. This is because the alphabet is very complicated and typing on a keyboard is even more complex and time consuming.
NC: Does the pen lead to many errors when recognising characters?
MR: It depends on the kind of data. The error rate is extremely low on check boxes, digits and dates. It is higher on free text but there are techniques to reduce it which you can build into your software. For example, if you tell the system that in a particular box you expect a drug name, and in another you expect a different field of vocabulary then the error rate can be much lower.
Also, connected to this pen are many tools, one of which is intelligent character recognition that improves the quality of recognition and is similar to the established optical character recognition technology.
NC: Do the benefits clearly outweigh the costs of the technology?
MR: The pen itself is a cheap device and costs about €200 and €300. In addition, you have to buy the licence for the patent and then build or buy the software. At Actelion we have built ours in-house so the cost for this is difficult to quantify.
In clinical trials the most important thing is the quality of the data and the feelings of the user. If we have a system that makes the end-user happy and is delivering high-quality results, then that is what is most important.
NC: Do you see one single technology revolutionising the EDC space?
MR: There are many different contributors but I do not see one solution. I do not trust electronic hospital records although it is seen as the future. I see integrating them as too complex for at least the next 20 years. It is not just a technical problem but a semantic one with each hospital having a different data structure.