Clinical trial data is critical to the approval and success of a new drug or medical device. Data collected in clinical trials plays a key role in making decisions about the viability and safety of new treatments as well as offering information that can be used to make important business decisions. One critical data point used in the clinical trial process is subjective patient reported outcomes. This includes quality of life information such as how a patient feels after taking a drug or symptoms that develop while using that drug. Handheld devices record patient reported outcomes that can be obtained in a clinic setting or in the patient's natural environment providing researchers with a wealth of valuable data.
Traditionally collecting patient reported outcomes is a long and drawn out process. Patients are typically assigned a paper diary that they use to record a wide variety of data at pre-determined times. For example, a patient enrolled in a clinical trial may need to write down their comfort level on a scale of one to ten at specified frequencies or at event driven moments such as taking a drug. This information is then collected by trial investigators, manually entered into a database and analyzed.
One of the newest and most exciting applications of handheld technology in healthcare is in clinical trial research. Electronic patient reported outcomes (ePRO) collected using handheld PDAs and larger tablet PCs have become a powerful tool for drug and medical device companies seeking real-time access to data and the best method for documenting and tracking the flow of information in the clinical trial process. This is especially critical in an age where this data comes under such scrutiny by the FDA and the safety of drugs and devices is in question.
Electronic patient diaries (EPD) are designed to be easy-to-use and are appropriate for use in studies ranging from geriatrics to pediatrics. In a clinical trial a handheld device or tablet PC can be used by many patients at a research site or individually by a patient at home. The software used for EPDs is graphically driven and provides the subject the option to respond to questions easily and quickly with the push of a button. This eliminates the stress of filling out a paper diary for some patients such as the elderly, younger patients, arthritis sufferers or others who have difficulty writing by hand. For example, patients can use images to click on parts of the body that experience discomfort. All of this information is then translated into data that is sent to a database through a regular telephone line at pre-determined times or uploaded through wireless means, connecting much like a cell phone. With this information available to the investigators and sponsoring drug companies so quickly, trends in data can be examined, giving researchers an early glimpse into potential safety and trial problems as they unfold.
By collecting data electronically, clinical teams can avoid many of the problems associated with paper-based collection such as patient compliance, maintaining clear and accurate audit trails, security, transcription errors and having limited or no access to data.
Unlike paper, handheld units can be equipped with a built-in reminder system (alarms, flashing lights, etc.) which can remind subjects when they must make a diary entry or when they are due for medication. This feature ensures that the subjects answer questions using information that is fresh in their minds as opposed to what they remember days or even weeks later. Technology has taken a key role in preventing patient reported outcomes that are non-compliant (e.g., back-filled or forward-filled). Because trial monitors have immediate access to the data and can monitor patient compliance, they can adjust enrollment to account for incomplete study data saving valuable time in new patient enrollment and screening.
Another challenge faced by trial researchers contributing to failed trials is subject dropout. By engaging patients in clinical trials through dynamic reminders patients are more likely to stick to the sometimes rigorous guidelines set forth by the investigative team. Patients have also reported they feel more comfortable responding to questions regarding sensitive topics to a nonjudgmental handheld device versus a face-to-face interview. In many cases, because of the convenience of the ePRO tools, subjects are less burdened by the many scheduled visits they would have made to a clinic by reporting results electronically. Built-in logic also ensures that checks are done after each question is answered making the entry of information more efficient. For example, some questions can be ignored if they are not applicable, such as those that are gender specific.
Vital to the clinical trial process is meeting requirements set by the FDA with a full audit trail. Because the time and date is automatically recorded after each question is answered, the data collected is much more accurate than that used in paper-based studies. It is important for investigators to track patient adherence to study requirements before spending time and money exploring other possible reasons for drug or device failure.
The entire research process benefits as data is collected and analyzed more quickly and frequently. Traditionally, forms completed by study subjects would need to be delivered back to the research coordinators, entered into a database and screened for errors. Researchers would have very limited access to data until the end of the study. By using ePRO tools, researchers have real-time access as patients upload data and can monitor their trial more closely.
This faster access to accurate data not only helps reduce the cost of the study but also enables researchers to identify any problems or safety issues while the study is going on. Should a patient have an adverse reaction to a drug, for example, the researchers can quickly intervene and address the problem. Also, should a study benefit from different questions being asked of the participants, a change can be implemented globally with very little effort compared to the manpower and cost it would take to reproduce paper diaries.
By doing away with paper patient diaries, the process of data clarification can be virtually eliminated. With close to $1.3 million lost each day an average drug is delayed to market, it is clear that timesaving tools like electronic patient diaries can have impressive returns on investment.
As the world's drug and device companies seek to acquire and evaluate clinical trial research data in the most accurate and expeditious fashion, expect to see technology used as a means to that end. While some new technologies are in full swing now, others are emerging and yet to be proven. Voice recognition software, for example, will become more robust and reliable. Perhaps we will see patients recording their information simply by speaking into a device. We may also see a time when important vital sign information will be automatically captured by plugging external devices into the PDA enabling information to be passed along immediately to researchers and caregivers in remote locations, allowing them to better monitor patient health.
Technology is advancing at what seems to be a blinding pace and there is no reason to believe this trend will not continue. Things we could not envision only a few years back have become part of our everyday lives. The use of PDAs in the clinical research area is a great example of this. There is no doubt that new technologies will proliferate throughout the healthcare environment, including the clinical trial research area, but what shape it will take is still largely unknown.
Richard J. Piazza, MS, PharmD is vice president, product strategy at etrials Worldwide, Inc. Dr. Piazza holds a BS in Pharmacy, Masters in Pharmacology, and Doctorate in Clinical Pharmacy (PharmD).