Testing new drugs is a difficult business. A late stage trial might well involve several thousand patients across the world. At the moment, these patients usually have to record information daily in a paper diary, handed to their doctor at monthly intervals. At best, the doctor then enters this information into her computer. More likely, the data will be sent to the trial organizers in paper form for processing.
Everyone involved knows the system is inefficient – and far from failsafe. According to Datamonitor analyst Maryann Lombardo, doctors say that a lot of diary information is entered in the parking lot just before patients come in. Remembering to write a daily record is hard at the best of times; if someone is also ill, expecting comprehensive entries just isn’t realistic. Even when the diary is complete, physicians will often find it illegible.
These problems are more than just a nuisance. Datamonitor estimates that delaying the launch of a blockbuster drug by a single day costs its maker in the region of $1-5 million. Problems collecting patient data could cost vast amounts of money. It’s clearly in pharma companies’ interests to find a better solution.
Ring ring… it’s time for your medicine
Mobile technology has obvious benefits, saving effort for patients and doctors and improving the quality of results. Mobile devices could be programmed to offer patients a simple, multiple-choice questionnaire, asking the same questions they would have entered in their diaries.
The technology is already here. Timo Ahopelto of Finland’s CRF Box, which sells wireless trial solutions, says his firm can program the mobile phone SIM cards and give it to the patient so that he or she can submit answers with our SIM card and use the other card for personal use. In Scandinavia and the UK, where more than two-thirds of people use mobiles, Mr Ahopelto’s solutions should be cheap and easy to use.
But mobiles aren’t just convenient. Since they are two-way devices, the trial can also remind patients to take their medication or to fill in data. Patients could use the phones to get help on how to enter the information, saving effort all round and ensuring better results.
Hackers keep out!
Security, however, is always a worry. Patients are unsurprisingly suspicious of trusting personal data to technology they don’t fully understand. As Ms Lombardo points out, Most wireless devices come with at least one option for providing security for the transmission of patient data, but to date these solutions are far from certain.
The PKI system that we use already more than meets the FDA standards for patient confidentiality, counters CRFBox’s Jaako Olilla. And after all, it’s much easier to read a patient’s diary than it is to tap into their mobile signal. Particularly since many systems transmit data without identifying context, meaning that even a determined hacker will be unable to turn the stream of numbers into meaningful data, it should become easier for pharma companies to reassure patients.
Mr Ahopelto is cautiously optimistic. Once the major players were committed, it only took two years to implement systems. The challenge for wireless is getting the major pharmas and the major IT players to commit to the technology.
Freeing doctors from their desks
Another popularly envisaged wireless opportunity doesn’t involve patients directly at all. Rather, the idea is to make life easier for physicians. At the moment, even if a physician does use IT in her surgery, she will still have to take details on a trial patient’s condition on paper and type them up into her PC later to send to the trial organizer over the Internet.
This cumbersome approach either ties physicians down at their desks or creates extra work for the physician or a clinical research associate. The obvious solution? Get rid of the fixed connections. Physicians could then use laptops or PDAs, connected to the Internet either by a mobile phone connection or by a wireless local area network (wLAN), to input trial data. Physicians would not need to interrupt their workflow to sit at a hard-line connected computer and fill in electronic case report forms.
Mr Ollila points out another advantage of this method, especially in the US. Big pharma companies already provide doctors with handheld devices, although more for CRM purposes than trials purposes at the moment, he says. As with consumers and mobile phones in Europe, if doctors already have and understand the devices, then integrating them into trials will be much easier. But Ms Lombardo points out, these marketing strategies provide handhelds to very small numbers of doctors, not necessarily the same doctors as those working in clinical research.
However, on a very basic level the majority of PDAs in use don’t have true wireless data capacity, requiring synchronization with a desk-based machine. And this kind of wireless trial doesn’t improve accuracy or compliance – it’s more equivalent to the general and gradual shift from desktop to mobile computing.
Slowly but surely…
It looks likely that physicians will eventually adopt wireless technology. But this will only happen because of the near-certainty that in all areas of business there will be a shift from fixed-line networks of desktop PCs to wireless networks of laptops and PDAs. Wireless networking is certain to be a major force over the next few years.
There’s no reason why physicians would be an exception to this rule, but they have been slower to adopt technology than enterprises have in the past. Only 5-10% of clinical trials are fully IT based at the moment, long after computers have become essential in many industries. And for the moment there aren’t really pressing advantages to conducting trials using PDAs over using Internet PCs – the saving in physician time just doesn’t justify the cost of the equipment and the training.
Eventually, though – and especially in Europe – mobile phones may well have the same ubiquity in clinical trials as in everyday life. Dear diary could be transformed into Hello handset.
