Rachael King is chief executive officer of CRF Inc.
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In today's technology focused world, paper-based administration is quickly becoming outdated. Despite the obvious benefits
of adopting a paper free approach to data capture, the clinical trials industry continues to be apprehensive about using electronic
methods. Patient reports can be the only way to reliably collect assessments pertaining to subjective information, such as
the perception of pain and fatigue. It is essential that this data be captured accurately, using the most efficient instrument
medium.
Approximately half of the 20-year patent protection period is spent on the drug development process. One of the largest cost
and time commitments during this time is clinical trial testing and the associated data collection and reporting from the
patients in the trial. On average, approximately $6 million to $11 million is spent on paper-based patient reported outcomes
(PRO) capture. With regulatory costs and government levies on the rise, the industry may need to adopt a more streamlined
and cost effective method of patient reporting.
The industry is familiar with the three main methods used in clinical trials to collect the important information from patients
as they progress through a trial. Interactive Voice Response (IVR), electronic PRO (ePRO), and paper-based instruments are
the primary ways to capture patient reported data. Each method has its own advantages for the clinical study management team,
but it is fair to argue that in terms of accuracy, compliance, and efficiency, ePRO is outperforming its main rival: the paper
questionnaire.
Paper vs. ePROLast year CRF Inc. conducted a study into compliance rates when using ePRO methods. The results were unequivocal: patient
compliance when using electronic diaries is more than three times that for paper-based trials. As we know, paper-based trials
usually have a patient compliance rate of around 30%. Compare this to the ePRO rate of 89.5% and this alone makes the argument
for using electronic capture extremely persuasive.
Six Areas of Distinction
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So why is paper still proving more popular? The traditional argument against ePRO has been cost. Investing money into the
purchase of eDiary devices from the outset can be off-putting for some. However, more and more clinical trials are moving
to ePRO as sponsors begin to recognize the savings that come down the line through improved efficiency, speed, and accuracy
of the data. In addition, the eDiary devices themselves can be reused for subsequent studies, lowering the effective cost
of the hardware over time.
Risk is a major factor for the clinical trial team when deciding on the medium to use for PRO instruments. The traditional
reluctance in using electronic data capture (EDC) methods has been attributed to an estimate of risk, with doubt over the
security and stability of using an electronic device to capture the patient data. However, the risks associated with paper
are far greater, with the potential for loss, damage, and inaccuracies.
ePRO reports can be sent to the study team in real time, removing the risk of losses in transit. All manner of accidents can
happen, leading to the paper being damaged or even lost before ending up back in the hands of the study management team. ePRO
also provides substantially more discretion and privacy for the patient; there is no possibility of a curious friend or relative
inadvertently or intentionally browsing through a diary left lying out.
The FDA's ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) criteria for patient data in labelling claims
have helped to substantiate the argument for using ePRO, as patient data is far more accurate when collected electronically.
