Medidata Blog

Taking ePRO to New Places – Replacing Paper

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According to a recent report from the Tufts Center for the Study of Drug Development, 64% of industry professionals believe ePRO is more expensive than paper and the remaining 36% believe paper is more expensive. Traditional ePRO solutions can actually demonstrate a positive return on investment (ROI) versus paper for trials with large volumes of assessments (the number of questionnaires/diaries multiplied by the number of patients).

However, special-purpose ePRO systems are simply too costly to consider for the majority of studies with smaller volumes of assessments and tighter budgets. Without a better alternative, sponsors resort to the old standard of paper data capture. But sponsors now have an alternative. Patient Cloud, a new model for ePRO, provides an ROI that allows sponsors to ditch the old kicks. As a starting point, it’s important to consider the fully loaded costs of using paper for patient data capture:

  1. Direct costs include (1) transcription of the paper forms into EDC by study coordinators and (2) the subsequent source document verification by CRAs.  These costs can easily reach into many hundreds of thousands of dollars depending on the number of assessments.
  2. Related costs include running queries for monitoring purposes and data cleansing by study teams.
  3. Others costs associated with paper include printing, shipping, kit administration, binding and storage
  4. The last and perhaps most significant cost of paper PROs relates to lower data quality. It is widely accepted in the industry that ePRO increases patient compliance because patients know they can’t “eFudge” the data. Increased compliance results in higher data quality and the need for smaller patient populations.

And further, what do patients, who increasingly have smartphones in their pockets, think when you tell them the accuracy of their PRO data is vitally important and then hand them a piece of paper to capture it? They no longer take you seriously. As the flagship for the new model for ePRO, Patient Cloud is cost effective at extremely low volumes of assessments: By replacing paper with Patient Cloud, sponsors benefit from eSource patient data and better engaged patients. Take ePRO to new places - try Patient Cloud.

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