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Medical device manufacturers rely on clinical trials and research studies to ensure their devices get approved for mainstream use. Clinical trial managers have to be very careful about gaining the consent of participants, recording that consent, and ensuring patients are informed of any changes that could affect their willingness to participate.
The COVID-19 pandemic drove the increased use of eConsent, and taught us all the importance of considering remote alternatives. Therefore it is important that medical device companies know how to use electronic consent modules efficiently, effectively, and with patients’ experience in mind.
eConsent (electronic consent) means simply giving consent to participate in research activities, such as clinical trials, electronically. It’s a digital replacement for a traditional “wet” or ink signature.
In one of our recent webinars, a poll showed that most participants had not used eConsent before. However, many were familiar with at least the concept of eConsent. There has certainly been recent accelerated use of eConsent in direct-to-patient (DTP) studies and decentralized clinical trials (DCTs). Clinical trial managers may find that gathering information digitally is safer, and simpler, than handing in documents face-to-face or sending them through the post. However, not all eConsent is done remotely.
Some of the advantages to using eConsent are:
With electronic signatures, medical device manufacturers can store, and back up respondents’ data electronically. This gives administrators ease of access to individual records, or an overview of everyone who participates in a particular study. Two-step authentication provides a high level of security for this data.
Electronic data capture tools also allow study participants to be shown necessary privacy law requirements, such as the GDPR, and keep a record that they confirmed they’re aware of their rights.
Finally, one last consideration for digital consent is that it reduces the requirement for in-person monitoring. However, even face-to-face consent that allows participants to engage with investigators brings all the advantages highlighted above.
Consent may fall under ISO 14155:2020 and ISO 20916:2019, which cover good clinical practice and good study practice relating to medical devices for human subjects. These documents comprise the fact that participants in studies must give informed consent. ISO 14155:2020 section 3.27 describes informed consent as:
“[The] process by which an individual voluntarily confirms willingness to participate in a particular clinical investigation, after having been informed of all aspects of the investigation that are relevant to the decision to participate.”
This is key for all clinical studies, there are no shortcuts with consent, and there shouldn’t be. Implementing eConsent requires that these guidelines are taken into account, providing potential participants with every bit of information they need in order to make an informed decision.
Any eConsent module should also encourage adherence to the principles of informed consent, such as not allowing participants to continue if they haven’t reviewed the relevant information. Too many apps permit users to skip past the Terms & Conditions (T&Cs). eConsent cannot allow this and remain fit-for-purpose.
The following are several key considerations that support medical device companies in using eConsent efficiently.
The first use case we’re looking at is for an implantable device, where a participant would visit the physician’s office. It is assumed they use Greenlight Guru Clinical (formerly SMART-TRIAL) with the eConsent module. The details of this case are as follows:
The significance of the participants’ age is that many of them could be less comfortable with the technology required for digital consent. They have to visit the site, but they may not own devices or bring any with them. Therefore, the site must provide web-based access for patients where necessary.
The other important factor is the mid-study protocol change. ISO 14155:2020 section 5.8.2 (j) specifically states, as part of the consenting process, to ‘’ensure important new information is provided to new and existing subjects throughout the clinical investigation, which may relate to the subject’s willingness to continue participation in the clinical investigation.
In other words, participants must be given information regarding any changes as well as the option to opt out of further participation. Greenlight Guru Clinical offers the functionality to update and inform participants within an hour or less.
Greenlight Guru Clinical (formerly SMART-TRIAL) provides various efficiencies in this use case, including:
The advantages over paper consent forms are clear and go far beyond the obvious storage and environmental factors of storing hundreds of sheets of paper securely.
The next use case consists of a much larger group, with more complex factors. The key points for this study are:
In this case, a renewal of the CE marking is required, meaning additional evidence is needed. The American study won’t conclude until after the CE marking submission is made, and it’s not possible to simply remove the device from the European market. So, there’s a huge volume of data available from users in Europe, but they’ve not given consent to provide their data as evidence.
Greenlight Guru Clinical can in this case be used to set up a registry database and request consent from existing and new patients. That consent can then be monitored by a central review team. The same registry works for existing patients (patients from the American study), and any new patients or study participants to keep the data as useful as possible. This really speeds up the process for medical device manufacturers without the losses of taking a device off the market.
Clinical trial managers and medical device manufacturers need simpler processes that take the patient experience into account without cutting corners. Find out more about how Greenlight Guru Clinical’s services can empower you to do just that.
Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.