Urgent search to integrate eConsent and provide virtual tools for clinical trial use.
If traditional clinical trials were already on the spot for a digital upgrade, the pandemic/lockdown situation made it now a top priority for the global healthcare industry. Especially, if researchers want to pursue their studies while keeping participants safe at home, they have to go digital and adopt eConsent.
Yet, what can be easily done when meeting in real life can be difficult to achieve technically. This is especially true for consent.
Consent under trials
“Informed consent” is the solid basis for any clinical trial. That is, the consent that an investigator must obtain prior to any experiment on a participant. Within the EU, this process is governed by the Clinical Trials Directive, soon to be replaced by the Clinical Trials Regulation (CTR).
According to the Directive, “informed consent” shall be defined as follow: “decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent”. As for the CTR, it provides us with a similar definition: “informed consent means a subject’s free and voluntary expression of his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the clinical trial that are relevant to the subject’s decision to participate”, and also adds that “informed consent shall be written, dated and signed”.
Thus, in order to enrol participants in a clinical trial, investigators must obtain their consent first, and are obliged by the law to provide them with all relevant information. We certainly all can picture how it would look like when an investigator and a participant meet in real life. The participant will come where the study takes place. Shake hands with the person in charge. See with his eyes how everything happens. And then they will talk.
At some point, some paperwork will be involved, and all the processes will be documented as it is required by the law. The participant will then be left with the choice to consent or not.
Now how do you implement that virtually? This is where eConsent solutions come in.
Electronic consent (eConsent) is the virtual equivalent of consent. So instead of having people meeting each other in order to exchange information and sign a piece of paper, everything is done remotely. Which is exactly what we need in a time of a pandemic disruption, and also to increase the potential and success of clinical trials in general, as it would open infinite possibilities for real world data collection and worldwide participants recruitments.
eConsent allows patients to continue consenting and enrolling in clinical trials when not being able to present in person, whether due to an isolation, physical condition or geographic location.
However, contrary to popular belief, eConsent is way more than a “checking a box” option – especially within the context of a clinical trial.
Even virtually, the law applies and obliges investigators to inform the participants, document everything, and so on. But more importantly, if you are looking to enroll participants into a decentralized and remote clinical trial, you will have to build a digital trust.
Solution: Pryv.io Privacy & eConsent Solution to build trust for your remote clinical trial.
Building a digital trust is the key to unlocking the difficulties of remote recruitment. When running a digital trial, you have to keep in mind that basically, you are asking people that you’ve never met to consent that you experiment on them. That certainly doesn’t bring much confidence.
So be innovative, adopt technology, provide more value. Just because you “have to” go digital doesn’t mean that you can not take this as an opportunity to push back the barriers and overcome the limitations of the current traditional on-site paper-based clinical trials.
Make a call. Use telehealth solutions to meet virtually. Build a virtual path to follow that will put your participants in the same situation that they would be if they would come to meet you.
Now how can we help you? Companies can deploy Pryv.io as a foundation for their digital clinical trials. Our software is specifically engineered to empower CRO and Pharma organizations to design and run decentralized, remote and patient-centric clinical trials.
While you focus on designing the perfect user interface for your patients, we provide you with a data management platform ready to welcome unlimited types of data from unlimited devices. So you can use IoT, medical devices and wearables to capture real-world data at any time, enabling you to unleash new discoveries during your trial.
We don’t access or host any data. You and your participants can even choose in which country you want the data to be stored – our platform is specifically designed to run multi-centric clinical trials at ease. Once stored, the data will be kept per-user, so you can easily show each participant his trial dataset and engage them in the process, sending a strong message of transparency and inclusivity.
Our Pryv.io platform also comes with eConsent and auditing tools so you can rapidly cook-up your own digital informed consent in compliance with CTR and GDPR. Our eConsent mechanism will allow you to keep track of every consent and related data-access per participant, while our audit solution will enable you to document the full process and retrace every access to the data.
Stephanie & Evelina @Pryv.