We plan to use wearable sensors for a clinical trial. What are regulatory expectations?
Dr Sanath Devraj
Wearable sensors are classified as digital health technology (DHT). These system use computing platforms, connectivity, software, and/or sensors, for healthcare and related uses.
Regulatory agencies like FDA except the DHT should undergo verification, validation, and usability studies. Verification is confirmation by examination and provision of objective evidence that the physical parameter that the DHT measures (e.g., acceleration, temperature, pressure) is measured accurately and precisely over time. Validation is confirmation by examination and provision of objective evidence that the selected DHT appropriately assesses the clinical event or characteristic in the proposed participant population.
FDA’s December 21 draft guidance recommends: Verification and validation may begin with bench top studies, progress to testing in healthy volunteers, and continue in individuals representing the population to be studied in the clinical investigation. These studies should include demonstration that the clinical event or characteristic is consistently and appropriately measured in the population.
Usability studies assess the ability of future participants to use the DHT as directed in the trial protocol. Usability testing should assess whether users are able to enter all data before being logged out of a DHT.
We are an IT company. We plan to provide free EMR to clinicians. Can we use data collected for research purpose?
Rushiraj Sharma
Data belong to the patients. The clinician, who collects the patient's data, should comply with requirements of good clinical guidelines. The clinician should obtain patient consent prior to any data collection and/or use and obtain ethics committee approval, as applicable. The clinician is the controller of the patient's data collected and should ensure secure and safe storage in his/her server or cloud.
What are important considerations in planning registry studies?
Dr Naresh Mahera
Registries should include: 1) demographic information, 2) clinical information, 3) treatment information, and 4) health-related outcome information for patients enrolled in the registry.
FDA draft guidance of November 21 stresses on the need for quality and reliability of registry data. This requires considerations of processes and procedures to govern registry operation, education and training of registry staff, resource planning, and common practices that help ensure the quality of the registry data. The FDA recommendations include:
• Established rules for the validation of queries and edit checks of registry data.
• Data dictionary to include: a) process of defining data elements, b) ranges and allowable values for the data elements, and c) reference to the source data for the data elements.
• Defined processes and procedures for
? Data collection, curation, management, and storage,
? Source data verification of registry data
• Compliance with 21 CFR part 11, as applicable, including maintenance of access controls and audit trails to demonstrate the provenance of the registry data and to support traceability of the data
• Adherence to applicable human subject protection requirements - privacy of patient health information, ethics committee approval, informed consent, plans for future use.
• Ensure data integrity.
• Ensure privacy and security controls to ensure preservation of confidentiality and security of data
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