Having recently been named to the Top 10 eClinical Companies for 2019 by Pharma
Tech Outlook Magazine, ClinOne brings substantial
benefits to clinical trials with its BYOD ePRO module. The main,
overarching benefit: zero data loss.
Adoption of BYOD (Bring Your Own Device) ePRO in clinical trials has
been measured due to regulatory, security and technical concerns. Now
that these concerns have been addressed and regulatory bodies have
approved, sponsors and CROs are diving in. Now, there’s an even more
beneficial reason to bring your trial into the BYOD world, and that’s your
data.
The Good News
Site sponsors benefit from the use of BYOD ePRO because of the reduced
cost over hardware-derived ePRO solutions, as well as significantly
reducing the site burden of having to allocate and deal with provisioned
devices. The more remarkable value and ultimate cost savings lie in
knowing that without the third-party devices which other clinical trial
sites outside of ClinOne use, being allowed to use their own devices,
patients will experience very minuscule to virtually zero data loss.
This positively affects the bottom line for sites and sponsors,
ultimately, avoiding loss of data which can disqualify patients,
incurring re-enrollment costs to the site. Viewed more holistically, we
can say that this means that data loss being eliminated, the risk of a
trial’s retention rates decreasing, or enrollments being stalled or
extended for a longer period of time – costing additional trial dollars
– is taken out of the equation.
Getting Down to Brass Tacks
ClinOne’s BYOD ePRO can reduce PRO costs by as much as 75% over the cost
of paper (mainly the hidden costs) and 65% or more over existing
hardware-based providers. ClinOne’s fully validated, regulatory
compliant ePRO solution is part of the ClinTrialConnect suite of
patient-facing technologies. Patients can access, complete, review and
sign their diaries or questionnaires electronically, utilizing DocuSign,
all through the ClinTrialConnect patient portal, and exported to the
sponsor’s preferred EDC vendor. Patients and sites automatically receive
a completed version of the signed questionnaire to add to their EHR.
“Research has shown that 86% of patients prefer ePRO to traditional
reporting and diary entry,” according to Chris Watson, MD, PhD and
Director of Product Strategy, Digital Patient, at ERT1.
Our ePRO module can eliminate the major issue of data loss which
presents itself and causes such issues as highlighted by
Mercieca-Bebber, et al: “High rates of missing PRO data can reduce study
power, inflate risk of type 2 error, bias interpretation, and
potentially undermine randomization.”2
A review of 36 ovarian cancer trials in this same report, showed that a
full “41% of trial participants had avoidable missing data (not
illness-related),3” which extremely affects the integrity of
the critical results for these trials.
Invaluable Addition to an Already Multi-capable Platform
“Utilizing ClinOne’s ePRO solution for the appropriate trials can lead
to significant cost-savings, particularly for those trials requiring
routine diary entries, over several months or years,” Rob Bohacs, CEO
and co-founder, states. “We are also planning a wearable sensor
integration in Q3 2019, which will allow correlation of data between
ePRO and live sensor data – an industry first.” Now, with the added
benefit of zero data loss, sites and sponsors can be assured that their
patients have a much stronger chance of remaining compliant throughout
the entire trial, allowing them to rely on all on-boarded patients,
having a much higher retention rate, altogether. You can see how this
translates into making the use of BYOD ePRO for all trials well worth
the investment.
1. Watson, Chris, “Increase Clinical Trial Patient Engagement and
Compliance with ePRO,” ERT.com, June 26, 2018.
2, 3. Mercieca-Bebber, Rebecca; King, Madeleine; Calvert, Melanie;
Stockler, Martin; Friedlander, Michael, “The importance of patient
reported outcomes in clinical trials and strategies for future
optimization.” Patient Related Outcome Measures, 2018:9, 353-357.
About ClinOne
ClinOne offers a complete suite of mobile and web applications to
enhance patient, family, caregiver and site engagement. Currently, our
solutions help support close to 3,000 clinical studies, across 1,900
research sites in 54 countries. If you are interested in learning more
or scheduling a demo, contact us. Visit www.clinone.com
for more information.
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