COVID-19 pandemic presents a significant challenge to clinical trials, including the rate of enrolling participants. Consequently, the industry leaders seek clinical partners who can offer patient recruitment services and speed up the enrollment process.
Site staff shortage or burn-out and possible COVID-19 exposure for patients during onsite study visits are two potential risk factors that stakeholders must mitigate.
How patients can be exposed to COVID-19 during onsite study visits
Participants may be unwilling to participate in clinical studies, especially site visits, due to their vulnerability to COVID-19. Such an issue compromises site visits and clinical studies in general. Ideally, patients now require greater care and will likely participate in lower-risk studies in the future.5
Similarly, documentation should encompass Risk Mitigation Statement Plans and Study Contingency that minimize COVID-19 exposure. This initiative may prioritize remote visits by replacing or reducing site visits without adversely affecting the data collection process.
These initiatives may include:
eConsent facilitates patient engagement in addition to being a convenient electronic version of the printed ICF document. The document improves such engagement in several ways, including:
- Use of multimedia tools to facilitate understanding
- Easy conversion to multiple languages
- Traceability of the consent
- Convenience, especially in providing information to individuals who are unable to attend clinics4
Covid-19 Embracing Technological Tools for Home Reporting
Remote data collection is possible by fitting patients with technology devices and automatically relaying the data to the EDC. Such tools can achieve various tasks, including collecting medical history, using electronic Patient Reported Outcome (ePRO) to pursue the quality of life and safety assessments and informed consent.6
Collection Bio-Samples from a Patient’s Home of Covid-19
While this approach does not offer complete protection against COVID-19, it may be recommended for some patient groups requiring regular safety monitoring.
Funding, data protection integrity, user instructions, and training sessions are essential prerequisites to effectively executing the above protocol. Legal impediments may emanate from a failure to uphold security and privacy standards in certain regions. According to the country’s legislative requirements, clinical studies must assess remote settings and procedures used for patient visits, such as technical specifications and validation profiles, etc.
In certain instances, regulatory restrictions bar clinical studies from seeking eConsent using an eSignature. A “print-to-sign” option may be viable under such circumstances. Stakeholders must have a backup “offline consent” alternative if tablets cannot be used for consent in a trial site. This approach should still capture such vital data as consent records and subjects even without eConsent.
It is essential to note the existing restrictions regarding remote patient visits and virtual technologies in a country of study. Such an initiative should begin as early as possible.
Dokumeds’ regulatory team provides such insight to the Sponsor during the country feasibility stage.
Shortage of Staff of Burn-out at the Site
Trial sites can experience staff shortage and burn-out. 3 Although some experts have uncovered ways to motivate and inspire their staff, achieving such a goal remains elusive. Clinical trials have been compromised globally in varying degrees, courtesy of the COVID-19 pandemic. The consequences of the pandemic on the recruitment process are inevitable. 6
Dokumeds seeks to engage the Enrolment Liaison Management (ELM) team to scale up enrollment risks assessments at all levels, formulate and execute mitigation strategies, and embrace viable initiatives to achieve site-specific targets. However, Dokumeds may engage a dedicated coordinator to address possible delays, such as backlog and other study-specific tasks
Dokumeds’ global reach and partnerships are here to help you overcome the challenges attributed to the COVID-19 pandemic. Contact our specialist team to discuss your clinical research needs during the COVID-19 pandemic.
Author: Janis Brix, CEO Wigwam