PHT Europe - Collecting quality patient-reported outcome data for efficacy and effectiveness

Accurate patient-reported data collection during clinical trials can be a tough outcome to achieve. Valdo Arnera MD, general manager of PHT Europe, suggests how electronic clinical outcome assessment data systems could solve this problem for the future.

A transformation is taking place in clinical research programmes for drug development as pharmaceutical companies replace paper diaries for collecting patient data with electronic clinical technologies.

100% of the top 20 and most of the top 50 pharmaceutical companies invest in eClinical systems and analytics that lay the foundation for electronic clinical outcome assessment (eCOA) data systems. eCOA within clinical research programmes includes patient-reported outcomes (PROs), clinician-reported outcomes (ClinRO) and observer-reported outcome (ObsRO) data.

Electronic clinical (eClinical) technologies allow sponsors, CROs and investigational sites to collect objective and subjective assessments of patient experiences. They provide high-quality data, accurate timestamps and real-time access to compliance, enrolment and safety-monitoring information.

Currently there are five proven modes for collecting eCOA data from patients, clinicians and observers: smartphones, tablets, phones, digital pens and the web. The most commonly used systems are device-based and IVR systems, both of which transmit data to a central server.

Paper vs electronic diaries (eDiaries)

Paper diaries offer no control over data timeliness or quality. In fact, backfilling diaries is so prevalent with paper diaries that the term 'parking lot syndrome' is used to describe patients who complete their paperwork in the car park just prior to a site visit. Such paper diaries are often incomplete, illegible and illogical. Patients also forward-fill paper diaries. A study published in the British Medical Journal showed that 45% of patients in a pain study invented data by forward filling at least once.

The patient perspective

Global researchers and regulators now understand the importance of the patient's perspective in evaluating and assessing drug safety, efficacy and clinical outcomes. eCOA data collection ensures attributable data by allowing patient responses only during the times specified by the protocol, while system controls ensure complete, legible and logical reports.

Trial participants using daily electronic diaries average 90% compliance rates. Most eDiaries have built-in alarms to remind patients to complete their diary. Many researchers are concerned elderly patients will be unable to complete electronic diaries, but the research proves otherwise with numerous studies showing no correlation between age and compliance.

The business case for eCOA systems

Reduced data variance is another major advantage of an eCOA system, as it enables smaller and more cost-effective studies. In an insomnia trial presented by Merck at the ISOQOL 2004 symposium, patients were randomised to either a paper or an eDiary arm and treated with an approved therapy. The results were a significant reduction in data variance in the eDiary arm vs the paper diary arm without any statistically significant change in the mean.

This same effect of eCOA systems reducing data variance has been seen and published in other trials across indications including urinary incontinence, irritable bowel and asthma. In the Merck example, the same study could have been run using just the eDiary with 56% fewer patients achieving the same statistical power and reducing costs by $350,000. The benefit to patients and regulators is the reduction of subjects exposed to investigational new therapies when there are other proven medical alternatives.

The bottom line - an approved drug

The unilateral goal of pharmaceutical companies is to develop safe and efficacious treatments that exceed the current standard of care. eCOA systems can deliver more timely scientific conclusions and can be the difference between an approval and a request for more information.

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