Anyone working within the pharmaceutical industry will understand the challenges that COVID-19 has presented to clinical trials. Keeping enrollment speed up is difficult whilst avoiding exposure COVID-19 during on-site visits; whilst the rate of staff shortage is likely to be higher, the process may be far less streamlined. The key to mitigating the impact of COVID-19 on a clinical trial is choosing a clinical partner who can assist with this.
In this article, we’re going to explore not only the impact of COVID-19 on clinical trials, but the ways we can overcome this.
Avoiding COVID19 Exposure During On-Site Visits
The concern surrounding being infected with COVID-19 can put patients off participating in a study; research has shown that patients are more driven to participate in studies that carry a lower risk of exposure.
Though stringent methods are, of course, followed in order to avoid this, patients expect to see clearly the steps that are being taken. Clinical trial documentation should include Study Contingency and Risk Mitigation Statement Plans. You may choose to reduce the number of on-site visits as far as you can without impacting critical data collection. Some ways in which you can do this are:
- To Implement eConsent
eConsent allows you not only to capture consent to a trial without a printed ICF but to improve participant engagement through a range of features. Multimedia tools that can convert between languages can enhance comprehension and aid the delivery of information, for example.
- Utilize Home Reporting
Technological devices can be used for home reporting; this lowers the need for on-site visits as data is collected and transferred remotely and automatically. At present, electronic tools can handle everything from medical history collection to quality of life or safety evaluations using ePRO.
– Collect Biosamples At The Patient’s Home
Whilst this approach cannot guarantee a lack of COVID-19 exposure, it does allow specific patient populations additional safety control.
Minimizing On-Site Visits:
Implementation of these procedures will require not only funding but adherence to user guidelines and training sessions, as well as data protection integrity. Every process and environment that is utilized for remote visits must be evaluated alongside country-specific requirements.
It is worth noting too that in some situations eConsent procedures are not allowed; in this case, “print-to-sign” is the best option.
Being aware of each of these restrictions and regulations is key to gaining sponsor approval. From the earliest stages, regulatory teams should provide insights on all of this. Dokumeds work to accelerate clinical trials by providing this information and offering clinical trial feasibility services.
The Impact Of Staff Shortage Or Burnout
It’s important to keep staff active and inspired, but the reality is that COVID-19 has disrupted ways of working in clinical trials; this is not only due to staff shortages but due to the impact from other pressures.
Traditional ways of managing this include the recruitment of extra staff and the offering of additional support to existing members. In addition to this, Dokumeds also engage their expert Enrollment Liaison Manager (ELM) team in order to ensure enrolment risk analysis at both a global and countrywide level is considered.
They are consistently working to develop and implement mitigation plans and targeted peer-to-peer approaches with those sites that require additional support to meet enrolment targets. In the case of a critical backlog, Dokumeds will assign a dedicated clinical research coordinator to provide external support to the site. As always, they are committed to meeting the shortest possible enrolment times.