Our Video e-Consent tool not only reduces costs for sponsors and CROs but also saves time
DENVER: The costs and timelines to conduct clinical trials continue to increase, as does study complexity. While much of the focus in clinical trials has been on improving data quality and overall study efficiency in order to address cost/timeline/complexity issues, less attention has been paid to the impact of patient non-compliance to drug treatment.
It's estimated that after just three months on trial, patient dose compliance drops to 75 percent and at 10 months, that compliance rate drops to 60 percent. Consider the implications of this non-compliance:
• In order to maintain the power of the study, more patients must be recruited
• This often requires opening additional sites
• Drug accountability at time of study close-out can prove to be more burdensome
• All of which mean extending the study timeline
• All of the above mean the study will cost significantly more to conduct
ClinOne has introduced Dose Manager, a cost-effective mobile solution to help address this problem. Utilizing simple text messaging, automated reminders are sent to patients (as well as caregivers, as needed) to encourage them to take their medication. Similarly, research sites receive alerts to signify the need for follow-up. Sponsors and CROs benefit from reports that are designed to highlight sites where non-compliance may be a concern, thus allowing for more focused monitoring visits.
"It's estimated that 91 percent of mobile users keep their phone within arm's reach 24/7, while 90 percent of all text messages are read within three minutes of receipt, so this is a highly effective means of engaging the patient and driving better dose compliance," says Rob Bohacs, ClinOne's founder and CEO.
DENVER: There's been much discussion over the last several years regarding use of BYOD (Bring Your Own Device) ePRO in clinical trials. Adoption has been slow due to regulatory, security and technical concerns. Now that these concerns have largely been addressed sponsors and CRO's are taking the plunge.
They recognize that sponsors benefit from the use of BYOD ePRO because of the reduced cost over hardware derived ePRO solutions, as well as significantly reduce site burden of not having to deal with provisioned devices. Site staff also aren't tasked with providing training and supporting patients on the use of the device. For patients, they get to use the device they use every day, which drives much higher compliance, typically in the range of 90% or better versus 25% or less with paper.
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 sponsors EDC vendor of choice. Patients and sites also receive a completed PDF version of the signed questionnaire to add into their EHR solution.
The ClinTrialConnect patient portal can also support patient training on how to complete ePRO instruments. Documents and videos can be uploaded to ensure proper completion to help further enhance compliance.
As Rob Bohacs, CEO and co-founder says, "Utilizing ClinOne's ePRO solution for the appropriate trials can lead to significant cost-savings, particularly for those trials requiring routine diary entries (daily or weekly) over several months or years. We are also planning our wearable sensor integration in Q2, 2019, which will sponsor to correlate data between ePRO and live sensor data – an industry first."
ClinOne offers a complete suite of mobile and web applications to enhance patient, caregiver and site engagement. Currently, our solutions help support close to 3,000 clinical studies, across 1,900 research sites in over 50 countries. If you're interested in learning more or scheduling a demo, contact us. Visit www.clinone.com for more information.
DENVER: More than a billion plaintext passwords from third-party breaches are freely available over the internet. Let that sink in, especially if you are one of the 59% of users who still use the same password everywhere.
These numbers are particularly sobering when considered in the context of the highly regulated clinical research arena. As clinical research becomes more mobile, sponsors and CROs are being pressured to provide tighter security measures to protect against unauthorized access to clinical data.
Biometric authentication allows technology platforms to replace passwords with physical validation of who the person is by using identifiers such as a fingerprint or facial recognition. Currently, 62% of all companies use biometric authentication and an additional 24% plan to incorporate the technology in the next two years.
ClinOne now brings biometric authentication through fingerprint and facial recognition to its iOS and Android mobile applications. This provides a significant improvement in security over using a password, stopping instances where a password is borrowed, sold, or stolen.
Biometric authentication paired with ClinOne's two-factor authentication (2FA) drastically decreases the risk of a data breach. It also favorably adheres to data protection laws, such as HIPAA and the EU's GDPR.
"Passwords are no longer considered enough in protecting sensitive data within clinical research. ClinOne's biometric and multi-factor authentication capabilities significantly increase security and privacy controls around accessing clinical data in the virtual environment," says Eric Schraufnagel, CTO and co-founder of ClinOne.