Priyanka Sawant

The COVID-19 pandemic has affected numerous lives globally, pushing the world to adapt and embrace innovative models to ensure continuity of business operations. As we see many countries slowly progressing with the “New Normal,” pharma industry, researchers, healthcare providers are assessing newer digital, virtual approaches which could reinstate the much impacted, clinical trials.

Informed consent, being the first step and hence one of the most critical processes in the clinical trial journey, has also been affected directly by the pandemic, as typically this process is carried out at the site in-person. The impact is not just seen, for new (to-be enrolled) patients, but also, existing patients, who are required to provide re-consents in accordance with the COVID-19 led changes for the study conduct.

In addition to the restrictions for in-person site visit, due to social distancing norms, COVID-19 also brought out some other challenges in areas such as traveling (e.g. impacted public transport) and reduced availability of investigators and site personnel (e.g. increased workload due to COVID-19 requirements).

To overcome the myriad challenges of COVID-19 on clinical trials, an expedited introduction and onboarding of an electronic Consenting tool could be a solution.

The virtual approach will enable sites to connect with patients without the need for in-person visits. Patients too can access the informed consent information at their own pace, read and review the easy-to-understand, multimedia, and interactive material without any pressure and discuss virtually, using telemedicine, any concerns with the investigator prior to providing their electronic signature. Updates to the consent material based on study changes introduced by COVID-19, can also be shared remotely and electronically, and by this maximizing the trial continuity.

For studies already using electronic Consenting but deployed at the site, the shift towards the at home setting will be relatively easy. However, for majority of the studies, using the traditional paper-based process, this shift will require a significant change in way of working.

For Roche, the current COVID-19 scenario imposed an immediate threat having a detrimental impact on many of its ongoing and critical new clinical trials across different therapeutic areas. As a result, the team had to act fast to find a way to ensure business continuity of the impacted trials across all geographies. Rapidly deploying a remote consenting process both for ongoing and new studies, and in compliance with country regulations, could be a solution.

Roche collaborated with TCS ADD team and implemented the TCS Connected Clinical Trials (CCT)—eConsent solution, to quickly rollout the digital informed consent. A close collaboration between both teams was the key to ensure that the application and onboarding process was aligned with Roche’s processes and end user expectations. The eConsent solution, which typically takes three weeks to implement, was deployed in a simplified way and enabled in just seven days. This fast track eConsent model was accessible at home through any medium—laptop, smartphone or tablets, in the patient’s own language.

For sites, the eConsent solution also reduced the administrative workload—something that was highly appreciated in the COVID-19 times—and focus more on patient’s targeted questions and concerns. For patients, being able to review the consent in an easier to understand multimedia format and at their own pace and be better prepared for the conversation with the investigator, was welcomed. Currently, the eConsent solution has already been successfully rolled out for multiple studies across global sites, and many more are being planned.

“With the eConsent technology, our studies will seamlessly address the current challenges of providing access to patients. The response received from the sites so far, is truly positive and paves the way for efficiently onboarding eConsent technologies and virtual trials,” said Mandy Sodhi, Clinical Operations Leader, Genentech (Roche).

Implementation of eConsent involves multiple factors in a typical clinical trial setting. However, considering the huge impact of COVID-19 on new and ongoing studies, dynamic and expedited working models need to be leveraged for catering to specific needs.

Following considerations are crucial for implementing eConsent for studies that require the quickest turnaround time:

Highly configurable tool able to quickly handle various study templates

Device-agnostic intuitive material such as videos, images, infographics, etc. and text

Leverage email or SMS messaging option to share eConsent link.

Access at home from any device, e.g. smartphone, tablet or laptop

Tool with virtual contact feature for site—patient connect

Tool with electronic signature or uploaded of printed signed forms sent via regular mail

Real time insights and oversight across all sites, for all partners

24x7 local helpdesk available for any queries or difficulties

“The implementation model has been the key to onboarding studies impacted by the pandemic and ensures the consent information reaches patients at home. Faster turnaround time for the study setup is providing the much-needed push to re-instate the trial enrollments,” says Ramachandran Prasad, Technical lead for Genentech (Roche).

While COVID-19 has been a dramatic experience, it has also shown that technology and team collaboration can help in navigating the negative impact on clinical trials. The hope is that post COVID-19 pandemic, pharma companies will continue to leverage eConsent and other digital patient centric technologies and move towards real patient centricity.

is the Senior Industry Advisor, TCS Life Sciences and Healthcare (Former Transcelerate eConsent Workstream Leader.) 

http://www.transceleratebiopharmainc.com/wp-content/uploads/2017/11/eConsent-Implementation-Guidance.pdf

Articles

As many countries slowly progress with the “New Normal,” researchers and healthcare providers are assessing digital/virtual approaches that could reinstate clinical trials.

Priyanka Sawant

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Fast Track Implementation of eConsent: COVID-19 Paves the Way for Virtual Trials