Informed consent, an integral part of clinical research, ensures that clinical trial participants are well-informed about all the relevant aspects of the clinical trial and that their participation is voluntary.

However, as clinical studies get more complex, informed consents are getting longer and less clear, defeating their intended purpose. According to a survey, 35% of patients who dropped out of a clinical study early mentioned it was difficult to understand the material contained in an informed consent.

Electronic informed consent, or eConsent, as it is commonly referred to, is the digital version of informed consent where paper is replaced with electronic consent. Allowing patients to consent remotely and avoid visiting the trial site can significantly reduce barriers and quickly enroll patients.

Benefits of eConsent include:

1. Interactive tools such as embedded pictures, audio, and video make the consent process more understandable and easier to read
2. Electronic signatures, version history tracking, and audit trails increase compliance
3. Template-driven document authoring for standardization and reusability across multiple studies and regions accelerate turnaround time
4. Collapsible document sections increased focus and retention
5. Document archiving and reduced paperwork

With the onset of Covid-19, the adoption of decentralized trials and hybrid trials are on the rise. This has led to an impetus to the use eConsent for clinical trials. Regulatory authorities also saw the benefits of using eConsent during the pandemic. They developed a free eConsent platform to help investigators obtain informed consent remotely when face-to-face interactions are not feasible. It previously only developed guidelines on the use of eConsent.

The increased focus on eConsent and its benefits is tremendous for patients and life sciences companies alike. We will continue to see that it increases patient engagement, leads to better patient retention, and improves clinical trial data quality.

If you are interested in enhancing the site and patient experience, please don’t hesitate to reach out.

There is a paradigm shift happening now in how clinical trials are being conducted. With the onset of COVID-19, physical access to the patients has been challenging, resulting in challenges in collecting, analyzing, and monitoring patients. However, every adversity comes with an opportunity. The pharmaceutical industry saw decentralized clinical trials (DCT) as a way to maintain clinical trial conductivity without any disruption.

Traditionally, when patients are enrolled in a clinical trial, they must travel to the designated site. And it’s not unheard of for someone to have to travel two or more hours for a visit. The investigator or a study team member would record the clinical data in the case report form. In DCT, this focus is shifted primarily to having less dependency on keeping the trial centralized and moving the clinical data collection activity to where the patient is located.

Decentralized trials are not new, and sponsors have been exploring and conducting these trials before the pandemic. In 2011, Pfizer successfully completed its first Decentralized Clinical Trial, “Research on Electronic Monitoring of OAB Treatment Experience (REMOTE),” where the Clinical trial Data was collected using mobiles phones and web technologies. Since then, significant progress has been made in this field, and DCTs have garnered much more attention since the beginning of COVID-19.

One major challenge of conducting any clinical trial is the complexity of recruiting patients. According to a 2019 study, 80% of clinical trials are estimated to fail to meet their required patient enrollment on time. Several factors can limit patient recruitment, namely:

• Finding the right patient: Sponsors and CROs are often not equipped to identify patients that meet the eligibility criteria
• Patient logistics: Volunteers are reluctant to enroll in a study that requires frequent travel to the clinics/sites, finding daycare for children, losing pay at work, etc.

Modern digital data capture methods and technologies, including e-Consent, wearable medical devices, eCOA/ePRO, online surveys, telehealth visits, medication home delivery, local lab testing, and remote monitoring, enable DCTs and help alleviate many issues that prevent patients from participating and completing trials.

Advantages of DCT:

1. Choice: Patients who would otherwise hesitate to join a clinical trial could now have an option to enroll without worrying too much about logistics
2. Convenience: In a “virtual” trial, the data can be accessed anytime, anywhere with 24×7 support.
3. Diversity: They enable participation from different population groups like the elderly, poor people, people living in remote locations, or minority ethnic groups that traditionally may not opt-in for a study.
4. Collaboration: Using digital tools, all stakeholders can collaborate on a near real-time basis, which reduces redundant back-and-forth communication.
5. Cost: With faster enrollment, the clinical study can be completed in a shorter duration, leading to significant cost benefits for the sponsors.

Even with the many advantages of DCTs, a few challenges still need to be addressed for widespread adoption to happen. For one, regulatory guidance for DCTs needs to be more precise. Second, as wearable devices have recently gained traction, it is important to create an ecosystem where data from different devices and technologies can be standardized, validated, and exchanged without data integrity issues. Another challenge is training site personnel and patients on using these digital tools/devices to ensure full compliance with the study protocol.

While there are challenges, the industry is quickly moving towards adopting DCTs. According to an Oracle Survey, “with patients unable to physically visit clinical trial sites, 76% of survey respondents noted that the pandemic sped their adoption of decentralized clinical trial methods. The same percentage (76%) reported at least some of their trials have already been decentralized, and 38% indicated more than half is decentralized.” This clearly indicates how the industry is swiftly evolving to the changing needs of conducting clinical trials and keeping patients at the center of this evolution.