Regulations aren’t keeping pace with technology when it comes to security and privacy issues and wearable medical data devices, and that can spell trouble for researchers in clinical trials, warns Marti Arvin, vice president of audit strategy with Cynergistek and a former chief compliance officer for an academic research center.
It isn’t as if researchers aren’t concerned about complying, Arvin stresses. The bigger issue is helping researchers understand how to comply.
“If you don’t make it easy for them, they are less likely to make it a top priority,” she says, in part because they won’t recognize when they might be veering out of regulatory compliance.
Meantime, the Clinical Trials Transformation Initiative (CTTI) just released a new set of recommendations for how best to develop novel endpoints generated by mobile technology for use in clinical trials. It outlines how doing this right will enhance patient centricity, efficacy, and overall efficiency.
Webinar: There’s an App for That: Security and Privacy Issues with Increased Use of Connected Devices, Apps, and Social Media in Research – On September 19, Arvin will review the various privacy and security issues and implications that need to be considered when research projects involve the use of connected devices, apps, and/or social media. Arvin will address issues such as IRB consideration, informed consent, and compliance with HIPAA regulations. View Program Details
Specifically, it recommends:
- Focusing on measures that are meaningful to patients.
- Selecting the device after selecting an outcome assessment.
- Using a systematic approach to identify key novel endpoints.
- Fostering collaboration among key stakeholders.
- Creating technical standards for mobile technology–derived assessment.
- Engaging with regulators.
- Including novel endpoints as exploratory endpoints in existing clinical trials and observational cohort studies.
- Thinking critically about how to optimally position novel endpoints in interventional trials.
“I think there’s a lot of overlap here between regulatory security compliance and CTTI’s recommendations,” Arvin says. “This is a good step in the right direction.”
Author: Michael Causey