Regulatory uncertainty and high costs may discourage decision-makers in biopharmaceutical companies from making full use of electronic patient-reported outcomes (ePRO) technologies in clinical trials, a new survey suggests.
Three out of four (75%) respondents in the survey commissioned by Premier Research, the clinical-development services company based in Philadelphia, US, reported having some recent experience with the use of ePRO technologies in clinical studies.
Yet 76% said they were confused about, or even unfamiliar with, the regulatory guidance for applying ePRO tools.
And while virtually all (98%) of the respondents said they were likely to use or were definitely going to use ePRO technology for clinical trials in the future, 45% also cited ePRO’s high cost as the primary obstacle to actual adoption, Premier Research noted.
A total of 51 high-level clinical development decision-makers in the field of analgesia, working for pharmaceutical and biotechnology companies primarily in North America and Europe, were interviewed for the survey during August 2012.
Hand-held best
Hand-held devices that feature ePRO technology were favoured by a more than four-to-one margin among the survey respondents, pointed out Premier Research, which also highlighted the particular utility of these tools in the pain arena.
The survey respondents largely agreed, with 71% acknowledging that ePRO applications were a valuable method of collecting data for analgesia clinical trials.
Only 6% of respondents preferred a telephone-based (interactive voice response) approach in this context, while 16% favoured web-based tools (interactive web response) and 12% traditional paper diaries.
Subjective data
“Pain studies rely on subjective data points which reflect the way study participants perceive pain – as to intensity, frequency, duration, and so on,” commented Michael Kuss, vice president, analgesia for Premier Research.
“Because pain studies lack objective measurements, such as a blood test, methodologies that optimise the objectivity of inherently subjective data are highly sought after.”
Moreover, time-stamped ePRO data can be monitored for compliance in real time, Kuss observed.
This is in contrast to paper diaries, which “are often presented to investigators days or weeks later”, he added. “The immediacy and thus the accuracy of ePRO is just huge.”
Still variable
Kuss did acknowledge, nonetheless, that immediacy alone cannot compensate for variability across different patients’ perceptions of pain.
