For the clinical research industry, COVID-19 poses immediate and longer-term challenges. For ongoing studies, sponsors and sites are looking for ways to modify protocols and keep patients engaged, especially as face-to-face interactions are being limited and access to facilities is discouraged. For the numerous COVID-19 trials that have been or will be started up on an urgent basis, sponsors and sites are seeking to apply digital technologies in new and faster ways.
All of us who have chosen to devote our careers to the pharmaceutical and medical device industries feel the weight of our responsibility to do all we can to hasten the end of this global pandemic in order to save lives and ensure healthcare continues to work the way we need it to. One of the ways we can do that is by enabling the continuation of clinical trials and the connection of patients with providers, investigators and opportunities, even as distancing remains in place.
Sharing experiences is vital to our industry, now more than ever. For the past month, my team has been responding to myriad questions regarding the potential application of electronic consent technology to both ongoing and new COVID-19 trials, and I want to share the ones most frequently asked about IQVIA eConsent, along with our responses, since it may be of value to your organization at this time.
Question 1: How can an electronic consent solution help me right now?
eConsent is a secure web application that works on almost any device, so it eliminates paper and pens, potentially reducing the risk of transmission of COVID-19 and other viruses. Utilizing remote consent capabilities, study participants can use their own devices in many cases, whether at home or in the hospital, further reducing the need for sharing and sanitizing. Seeking reconsents for protocol amendments remotely may be feasible in ongoing studies; and obtaining initial consents for new COVID-19 or other trials may also be conducted remotely. Our team can discuss and help evaluate your studies to answer this question in detail and make specific recommendations.
Question 2: How does remote consent work?
The IQVIA eConsent solution enables the investigator to transmit a site-specific URL to a potential participant, by text, email, or verbal communication. From there, the investigator or delegate can walk through the informed consent form (ICF) with the patient while on the phone and make sure everything is understood.
It’s important to remember that informed consent is not a “contract” that simply needs to get signed - it’s a process through which the investigator and patient discuss the ramifications of clinical trial participation and ensure those ramifications are thoroughly understood. In this regard, the signed ICF is simply an artifact that demonstrates the process took place. eConsent can fulfill that obligation more robustly by automatically generating an irrefutable audit trail that provides far more information and understanding than a bottom-line signature.
Question 3: How long does it take to set up eConsent?
For new high-priority studies, we’ve been asked to meet some very short timelines; and my team has established a number of ways to expedite delivery – down from weeks to days – and enable patients or legally authorized representatives (LARs) to consent quickly. We can adapt this to the specific needs of each study, and our team has extensive experience to support IRB and health authority approvals.
Question 4: What are the downsides of using verbal consent?
Verbal consent has all the downsides of the physical paper consent process, including the lack of automated tracking and reconsenting, plus the added burden of documenting the conversation between investigator, patient or LAR, and witness in an auditable fashion. Although the COVID-19 regulatory guidance appears to provide a relaxing of requirements, the investigator remains responsible for documenting that a proper informed consent process took place, and the sponsor remains responsible for overall study conduct. Remote consent is a tool that sponsors can provide to their investigators to help them ensure quality and traceability and demonstrate that patients were properly consented.
Question 5: Are there additional benefits to remote consent?
eConsent is a solution that benefits patients, sites, and sponsors in numerous ways under “normal” clinical trial conditions. For ongoing studies and new trials during the COVID-19 crisis and beyond, remote consent is providing these additional advantages:
- Allows remote monitoring by CRAs and study monitors
- Reduces travel burden and fear of exposure in patients and staff
- Gets patients consented or reconsented in a simple, cost-effective way
- Securely transmits signed eConsent forms
Every trial brings its unique challenges. For some sponsors, time is of the essence; for others, regulatory acceptance of electronic consent outside the US is the larger concern. Please don’t hesitate to reach out to my team directly by sending an email to TDSE_solutions@iqvia.com to engage our eConsent experts as early as possible and discuss all potential solutions to your specific situation.
IQVIA is doing all we can to help reduce the impact of the global COVID-19 crisis. Let’s keep sharing information to hasten the development and delivery of treatments and vaccines to the world.