Medidata Blog

Taking ePRO to New Places

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Why in this day and age, with people connected 24x7 via smartphones and apps, do clinical trials still use paper to capture patient-reported outcomes (PROs)? ePRO solutions have been around for decades, but up to half of studies still use paper to capture patient assessments. Despite the site burden and costs Although a known entity, paper is not an easy medium to work with. Sites have to concern themselves with the logistics, transcription and archiving of the physical assets. Sponsors have to budget for these activities as well as having monitors perform source data verification (SDV). Despite regulatory guidance Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), stated recently that “Data quality in general needs industry’s attention.” The FDA, for example, “promotes capturing source data in electronic form.” Despite the “Parking Lot” effect Perhaps the most damning aspect of paper is the "Parking Lot" effect. Asking a patient to report their experiences on a piece of paper in today’s connected world leaves two impressions:

  • “They obviously don’t care all that much about the data.”
  • “This feels like homework. I’ll do it later.”

Even the best effort by patients to accurately recall their experience is subject to bias. And if they don’t complete their diaries until their next office visit, the added time pressure may lead to fabricated results. It’s time for industry to address this critical need. Watch the accompanying video to hear Anne Zielinski describe recent industry trends regarding patient-reporting outcomes and patient engagement. To join the discussion, register for the following upcoming free one-hour webinar:

  • The Voice of the Patient in Clinical Trials: Hearing It, Understanding It September 10, 2014 10:00 am-11:00 am ET Medidata’s global lead for patient engagement Anne Zielinksi delves into patient self-reporting, examining the use of paper and electronic patient-reported outcomes (ePRO) and how organizations can increase the quality of their patient-reported data to improve their clinical trials and the patient experience.  Register

*Guest blogger David McNierney is a product and solutions marketing director at Medidata. You can reach David by email or follow him on Twitter @davidmcnierney. TWEET THIS:

Up to half of #clinical studies still use paper for patient-reported outcomes. Why? Video & blog on recent trends:

— Medidata (@Medidata) August 6, 2014

Additional blog posts by David McNierney:

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