PHT Corporation managing director Valdo Arnera MD and senior marketing manager Christine Hall compare the five devices used to acquire attributed patient-reported data, and examine why selecting the best one for clinical trials is an important decision.

The specialised industry of collecting electronic clinical outcome assessments (eCOAs), including patient-reported outcomes (PROs), is growing exponentially. This is because global government regulators want to hear directly from the patient, and because electronic collection (compared with paper collection) improves data quality and efficiency for analysis and trial management.

The ‘FDA Guidance for Industry . Patient-Reported Outcome Measures’ states: "The degree of respondent burden that is tolerable for instruments in clinical trials depends on the frequency and timing of PRO assessments in a protocol, and on patient cognition, illness severity, or treatment toxicity. For example, if the questionnaire contains instructions to skip one or more questions based on responses to previous questions, respondents may fail to understand what to do and make errors in responding, or find the assessment too complicated to complete. Sponsors should consider missing data and the refusal rate as possible indications of inappropriate respondent burden or inappropriate items or response options."

This means that the FDA does not want sponsors to place undue burden on patients. eCOA systems minimise respondent burden with features that make even complicated questionnaires simple for patient populations of all ages.

Globally, there are five proven ways to collect eCOA/PRO data – smartphone, interactive voice response (IVR), web browser, pen and tablet. The device or combination of devices most suitable depends entirely on the protocol requirements, so the following questions must be asked:

  • Where will the eCOA/PRO data be collected – in transit, at the clinic, or both?
  • Will the eCOA/PRO data be collected using simple or complex questionnaires and/or diaries? ‘Simple’ means short and brief questions that require dichotomous responses; ‘complex’ means long diaries, many questions, questions using body graphics, and/or visual analogue scales.
  • Will eCOA/PRO data be collected frequently, episodically, or infrequently? ‘Frequent’ refers to timed assessments, on a fixed schedule, daily or several times a day. ‘Episodic’ refers to event-driven data collection. ‘Infrequent’ means periodically, seasonally or annually.

Conclusion

Each type of eCOA device has been used for successful data submission to regulatory agencies, and each has specific utility for protocol requirements. Selecting the best device or devices for a clinical trial should be a decision based on these requirements.

Regardless of which ones are used, eCOA devices are proven to collect attributable, legible, contemporaneous, original and accurate data – the standard for evidence that is expected by regulatory authorities for accurate clinical outcome assessments.