Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations
It may seem to us to be mundane.
We have a goal of 10,000 steps a day. When the Fitbit buzzes, we?look, and see the Fitbit has logged 10,000 steps. Hurray!
But is that right? Should we trust this technology blindly?
My Fitbit can also function as an Oximeter - providing me data about my blood oxygenation levels.
The leap to leverage this Oximeter data in a clinical trial in support of a new Asthma medicine, for example, is very short.
I am part of the All Of Us program. I opted to have my Fitbit data?automatically surrendered for the good of the program. Many of the other participants have done the same.
How do you know whether the data gathered from these Fitbits, or in a distributed clinical trial, in a remote location, is valid?
If it is easy to manipulate or falsify, without detection, there may be an incentive?to make things look better than they are? Bad news, such as not being able to meet clinical trial primary end points?have a tendency to depress your company's?stock prices.
Distributed Clinical Trials (DCT) became the?way we continued running clinical trials during the pandemic. This approach of bringing the clinical trial to the patient, rather than dragging the patients all the way to the clinic, has become more popular in part also due to the expansion in use of health sensors - smart watches, Fitbits, smart phones, etc.
Have you considered:
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FDA have defined these types of devices as Digital Health Technology (DHT).
"A DHT is a system that uses computing platforms, connectivity, software, and/or sensors for health care and related uses. DHTs may take the form of hardware and/or software.?In many instances, DHT software may run on general-purpose?computing platforms (e.g., mobile phone, tablet, or smart watch)."
In addition to defining DHT, the FDA also provided a DRAFT Guidance: Questions and Answers Guidance for Industry at the end of March.
More recently they also hosted a webinar in support of this DRAFT guidance issuance.
In the Draft Guidance they provide a pretty broad definition for the data originator (Section III. D. Q20):
"The data originator may be a person, a computer system, a DHT, or an EHR that is authorized to enter, change, or transmit data elements via a secure protocol into a durable electronic data repository, such as an EDC (Electronic Data Capture) system, a clinical investigation site database, and/or a vendor database (e.g., database of the CRO (Contract Research Organization), IT service provider, DHT manufacturer)."
"If a participant manually enters data into the DHT and the data are then uploaded into a durable electronic data repository, the clinical investigation participant should be identified as?the data originator.?In cases where another individual (e.g., clinical investigation personnel,?health care provider, parent, or other caregiver) enters data on behalf of the clinical investigation participant, the individual entering the data should be identified as the data originator, and the reason should be documented."
"If a DHT, such as an activity tracker or a glucose sensor, transmits data automatically to the?durable electronic data repository without any human intervention, the DHT should be identified?as the data originator. In these cases, a data element identifier should be created that automatically identifies the particular DHT (e.g., name and type) as the originator of the data?element. Other information associated with a data element, such as the date and time of entry?and the unique identifier of the participant to whom it applies, should be recorded in the durable electronic data repository."