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Handheld Computers in Clinical Drug Trials

Without doubt, one area in which mobile information technology is making rapid headway is in the field of healthcare, and experts agree its future looks promising. Today's market includes software that facilitates the introduction of data into a patient's clinical history record to devices that measure respiratory function via a direct connection to the handheld PC. One field in the medical-pharmaceutical world in which technology has already moved from science fiction into a handy tool of trade is in field tests to evaluate the efficiency of drugs, also known as clinical trials.

Clinical trials form part of the process of investigation in which a group of physicians from various hospitals around the world gather data about the efficiency of a new treatment or medication in a group of patients, then compare it with a control group. The data collection phase is crucial for assuring the global quality of the study, and this is where pen computers come into their own.

Key to the success of a clinical trial is the design of a data-collection log (also called case report form, or CRF), the form which doctors use to write up data and note a patient's evolution. Traditionally, paper forms have been used, but this can present problems such as not being able to read what is written, filling out fields incorrectly or incompletely, and problems with data coherence that could be controlled by electronic gathering systems - prescribing contraceptive pills to a man, for example.

The need for posterior data digitalization, the slowness in transmitting information and, most importantly, the impossibility of checking data quality in real time, are what make the computerization of any step so important to the success of a clinical investigation.

For some years now, some companies have been developing applications that allow digital data entry and the resolution of inconsistencies and errors - the famous "queries" in common jargon, but only a few have introduced handheld PCs as key tools in this process. Until now, improvements in these applications were based on simple Internet (HTML) pages that contain some of the controls necessary for the initial validation of the information introduced by each doctor. The system consists of an handheld PC connected to a cellular phone through which information is sent and received.

However, this method has two significant shortcomings. The first is that data introduction and checking takes place by phone in real-time, which means phone bills can be considerable if the doctor has to be on-line while filling in a lot of information; and secondly, the applications are developed in HTML, with its inherent limitations compared to a conventional software application.

Recently, Infociencia Pty Ltd (you can pronounce it "info-science"), a young Spanish company currently developing this type of project in the pharmaceutical sector, has managed to fit miniature computers with the software needed to carry out the work formerly done by their grandparents, the table-top PCs. The development of this software, in the powerful programming language of Visual C++, has allowed the creation of applications capable of evaluating the medical information contained in a local database, which, after being verified in the handheld PC, is sent by the traditional mechanisms of the Internet to the study's monitors with a greater guarantee of success.

Dr Josˇ Manuel Mas, Ph.D., Technical Director of Infociencia, says, "Our system presents a series of advantages both for the doctor and for the pharmaceutical laboratory organizing the study. In the first place, it cuts the cost of data transmission because the doctor only goes on-line to send his or her local database and then again later to recover a file with the new information the study monitor has sent. The quality of the data is also improved as the information is validated and contrasted internally thanks to a special application developed in Visual C++ for Windows CE, which makes possible a host of things that couldn't be done in HTML. One example is you can now introduce a dictionary with instant access to more than 5,000 medical terms, or develop a complex algorithm to help the doctor decide what is the best treatment to follow with each patient. What this means is that we have made a handheld with the same technical capabilities as a portable PC, but at a quarter of the cost."

The choice of hardware is also crucial to the success of a project, says Dr. Mas, as "you need to have an apparatus that guarantees a perfect understanding between communications support and processor capability. Data memory back-up is also vitally important given the possibility - or rather, likelihood - of losing information due to batteries running out." To put it in plain words, the worst clinical remote trial is better and cheaper than the best traditional paper-based clinical trial.

There is a bright future ahead for clinical trials using handheld PCs, thanks to their ability to reduce the period a drug needs to be under evaluation before it can be commercialized. The improvement in data quality and the reduction in its digitalization time, along with the reduced cost of the apparatus clearly translate into lower global costs, something always to be taken into account. Needing fewer specialized personnel and reducing time spent obtaining valid information are important objectives, as it is possible even to computerize processes in such a way that statistical treatment runs parallel to data gathering. And, in the world of health investigation, rapid time-to-market saves money and can help alleviate suffering for many people.

Jordi Naval, Ph.D., is Development Director of Infociencia Pty Ltd. You can e-mail him at

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