There are organizations that still use paper to conduct clinical trials, so why make the switch?
April 12, 2017 | by Sandra “SAM” Sather, MS, BSN, CCRA, CCRC Regulatory and Quality, TrialConsentTM, CRF Health VP, Clinical Pathways
The State of eConsent 2017 Report released by CRF Health surveyed 100 biotech, pharmaceutical, CRO, and IRB organizations who shared their opinions on Electronic Informed Consent (eConsent) and its ability to produce greater levels of efficiency, effectiveness, and patient engagement in clinical trials.
With so many industry leaders moving to eConsent, others are left wondering why? There are organizations that still use paper to conduct clinical trials, so why make the switch? The 2017 report points to some interesting statistics about why more companies are adopting eConsent.
In our upcoming webinar, we’ll discuss the following eConsent Report benchmarks:
- Drivers of eConsent. Respondents were asked to rate the drivers of eConsent from most influential to least influential.
- Design and deployment functionalities. Standout benefits in electronic compared to the traditional paper method are compared.
- Participant engagement benefits. What eConsent features do study teams find most useful for participants?
- Reporting and analytics. Is measuring site and participant performance easier with eConsent? How?
- eConsent benefits. A look at the #1 benefit of eConsent, according to respondents.
- ROI measures. Did our respondents find positive ROI with eConsent?
- Current use and projected future use of eConsent. Overall trends in eConsent, both currently and in the future, are analyzed and discussed.
Also, the survey respondents reported that by 2020, an impressive 82% of pharmaceutical companies will have adopted eConsent and 66% of the top 50 pharmaceutical companies are already engaged with or planning to adopt an eConsent solution in the near future.
Further supporting these claims is the December 2016 U.S. Food and Drug Administration’s (FDA) final guidance document on use of eConsent in clinical trials. The guidance emphasizes the need for informed consent to be more effective and efficient in providing support to the participant so that they understand the content and can make an informed voluntary decision. The guidance clearly states that research shows when information is presented in a multimedia format, as opposed to the traditional paper linear format, informed consent is more effective. This is just one instance of support for eConsent. But with so many claims made about the impact eConsent has on a clinical trial, CRF Health wanted to know how key leaders in the industry perceive it. What are their experiences with eConsent? What do they think about its features and future use?
Join our webinar, “Electronic Informed Consent: 2017 Industry Survey Results,” to hear how the industry measured eConsent by proving or dismissing common assumptions. Plus, learn about what’s in store for the future.
Keywords: Electronic Informed Consent, Clinical Trials, FDA
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