Industry leaders understand that keeping sufficient enrollment speed in clinical trials amidst the COVID-19 pandemic is a challenge. They are looking for clinical partners who can mitigate the impact of COVID-19 and achieve patient recruitment targets.
Two potential risks to patient enrollment have to be considered and mitigated:
The possibility of patients being exposed to COVID-19 while visiting the site constitutes a significant barrier to their willingness to participate in a study.
Current trends show that clinical studies are progressively moving towards greater complexity. This moves counter to patient expectations, who now request greater convenience of care.\(^5\) This means that patients will be more motivated to participate in studies that carry a lower risk of exposure to COVID-19 due to protocol procedures than in the studies with higher risks of infection exposure.
Likewise, documentation should include Study Contingency and Risk Mitigation Statement Plans that outline options to enhance existing protocols. This may include possibilities to reduce the number of on-site visits or to replace them with remote visits, without impacting critical data collection. Possible measures include:
eConsent is not simply a conversion of a printed ICF into an electronic document. It also holds the promise of improving participant engagement in clinical trials through a variety of features, which include the use of multimedia tools to enhance comprehension, ready conversion into multiple languages, a means to track consent in a highly portable manner; and the opportunity to provide information in a more convenient way to persons with an inability to attend clinics.\(^4\)
By outfitting patients with technological devices that can be used for home reporting, a study can collect data remotely and transfer it to the EDC automatically.
At present, several activities can be potentially provided by electronic tools. This includes informed consent, medical history collection (especially when addressing eligibility criteria during the screening procedures), and quality of life or safety evaluations using electronic Patient Reported Outcome (ePRO).\(^6\)
Such an option does not protect patients fully from COVID-19 exposure. However, it can be considered for specific patient populations treated in studies that require very frequent safety control.
Implementation of all these procedures requires funding, user guidelines, training sessions, and data protection integrity. The lack of privacy and security standards in some regions will also play an important role in the legal challenges. Any environment and process used for remote patient visits has to be evaluated alongside country-specific regulatory requirements (e.g. validation profile, technical specifications etc.).
In some cases, eConsent procedures using an eSignature, (where patients and witnesses sign directly on the tablet and the signatures are captured electronically) may not be allowed. In such cases, a “print-to-sign” option can be considered. If a site is unable to use tablets to consent for any reason, a backup process of “Offline consent” must be implemented. This should still capture the study subject number and consent record without using eConsent.
From a Sponsor’s perspective, it is critically important to be aware of restrictions related to virtual technologies and remote patient visits in each country where the study is planned. This should start from the earliest stage. Dokumeds’ regulatory team provides such insight to the Sponsor during the country feasibility stage.
COVID-19 related health service staff shortages and burn-out can happen on site.\(^3\) Some Principal Investigators have found ways to keep their staff active and inspired, but in some cases it is very hard to achieve.
Following the COVID-19 pandemic, we saw a global disruption of clinical trials across the world. Varying effects on recruitment are unavoidable.\(^6\) In addition to traditional recruitment techniques and support provided by assigned CRAs and PMs. Dokumeds also proposes engaging our expert Enrollment Liaison Manager (ELM) team to ensure enrollment risks analysis at the global/country/site levels, developing and implementing mitigation plans, and developing targeted peer-to-peer approaches to individual sites requiring additional support to ensure their enrollment targets are met. In the event of a critical backlog at the site in data entry or any other study-specific activities, Dokumeds can help by assigning a dedicated clinical research coordinator to provide external support to the site, which can help reduce the backlog within the shortest possible timelines.
The global position of Dokumeds and its partnerships are here to help you offset the challenges put in place by the COVID-19 pandemic. Contact our specialist team to discuss your clinical research needs during the COVID-19 pandemic.