SELECTION OF THE MOST APPROPRIATE EPRO MODE- CONTRIBUTING TO THE SUCCESS OF PATIENT-CENTERED CLINICAL TRIALS

Author(s)

Ross J, Holzbaur E, Rothrock T
Almac Clinical Technologies, Souderton, PA, USA

Throughout the more recent years, clinical trials have become more patient-centered, where patients are now the principal factor in the study’s success.  Patient-centeredness in clinical trials is essential because it enhances the evidence needed to make more informed decisions relating to drug development. Patient Reported Outcomes (PRO) in measuring treatment efficacy, safety, and clinical trial endpoints make a significant contribution to the patient-centeredness of clinical trials as the responses come directly from the patients.  As the benefits of collecting PRO data electronically far outweigh paper, the use of electronic Patient Reported Outcomes (ePRO) systems are also becoming more prevalent. Common ePRO modes used in clinical trials include Web, Phone, and study-provisioned handheld devices. Technology advancement has brought about the novel approach of Bring Your Own Device (BYOD), where rather than the sponsor provisioning a study-dedicated device, the patient uses their own device (such as their own personal smartphone) to enter their PRO responses.  As PROs are often used as study endpoints, and with having both the traditional sponsor provisioned device and novel BYOD approaches available, choosing the most appropriate mode remains a critical decision to the trial’s success.  In considering the patient-centeredness of the clinical trial, the choice should focus on what is best for the participating patient population while still rendering appropriately and capturing quality data. The ePRO selection process should be based on the following considerations: the study’s patient population characteristics, study design, study logistics and instrument characteristics. Making the appropriate ePRO mode choice will lead to enhanced patient experiences, higher quality data and higher compliance. This conceptual paper will describe the available ePRO modes, discuss key considerations of the ePRO selection process, and provide examples on how to choose the most appropriate ePRO mode.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PRM214

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Multiple Diseases

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