eConsent for Decentralized Clinical Trials
Remote patient consent in clinical trials and beyond

eConsent for Decentralized Clinical Trials

Remote Patient Consent

The current COVID-19 situation has placed a great strain on medical center resources. Due to social distancing, it has emphasized the need for remote clinical trials. As such, many medical centers are relying more on digital tools and technologies. Through telemedicine and virtual care, medical centers can deliver healthcare from a distance.

Through this method, physicians are still able to perform quality medical-care services. Although, there is a degree of adaptation. Services range from medication history reviews, health therapy management, and health education to remote drug reviews. This can promote social distancing, reduce disease transmission, and reduce waiting times.

How Remote Patient Consent Impacts Clinical Trials During COVID-19

Remote patient consent actually presents several benefits to the progression of clinical trials. Traditional methods often face recruitment issues. For example, they may fail to get a suitable number of research participants. This causes a bottleneck in clinical trials. It can result in costly time extensions, underpowered results, and even early termination.

With COVID-19 comes the increase of remote clinical trials. Social media allows researchers to reach patients in remote locations and recruit them for trials. This increases the subject pool available for remote trials. In the case of traditional trials, this can be more difficult. Often, suboptimal recruitment is due to a laborious consent process and the inability to access participants in remote locations.

However, new electronic consent (eConsent) technologies can tackle this. They can improve readability and consent management. Whilst the process is similar, eConsent embeds the process of informed consent into a telemedicine session. This might be done by remote video conferencing between researchers and prospective participants.

Thus, the patient can go through the consent form in real-time in an interactive manner. Both individuals can sign the consent form and print the document for archiving. Such a method eliminates issues of traveling and social distancing that patients now face during the pandemic.

The Process Of Remote Patient Consent

As remote patient consent becomes more popular, it is predicted that they will follow a telemedicine process lifecycle. Usually, this begins with patients reading the information on the trial, before consenting and registering.

However, there are many international discrepancies in conformed consent laws for telemedicine. There are two types of consent for remote patients: written and verbal consent.

Some clinical trials need written informed consent where a patient must sign a form. Utilizing technology makes this process much easier through eConsent. Procedures that carry a more significant risk will require written consent.

If a treatment or procedure does not have significant risk, verbal consent may be sufficient. This would occur on a video call between the patient and the practitioner or relevant personnel from the clinical trial.

Final Thoughts

Adopting eConsent for clinical trials is not without risk, but the benefits cannot be ignored. By partnering with a dedicated platform, clinical trials can manage everything from one place. Through this, they can make the whole remote patient consent process easier for everyone involved. From eConsent and scheduling events and medication notifications to televisits, this is the future of healthcare.