Guidance on the management of clinical trials during the Covid-19 pandemic

Posted on: 07.05.2020

Due to pandemic covid 19, we all face now new situations which change substantially our way of doing our routine work: impossibility of the patients to visit the site for performing the study visit, delays in the shipments of medication to site, questions regarding the stability of the study medication, monitors unable to visit the site, inspectors who cannot perform their routine inspectionsa at site, etc.

Since patients cannot follow their study visits normally , some pharmaceutical companies have developed new solutions or concepts such as remote-based monitoring, centralized risk-based monitoring, data analytics tools, e-consent, ePRO tools, telehealth and home visit optionality

The competent authorities FDA or EMA have issued some guidelines for helping the industry, investigators and patients to survive these covid pandemic period.

The “Guidance on the management of clinical trials duging the covid 19 (coronavirus) pandemic”, v.3, 28 apr 2020, says that “The impact of COVID-19 on ongoing trials, on opening new trial sites in an existing trial, on ongoing recruitment and continued involvement of participants in the trial, or on starting of new trials needs to be considered. This evaluation should take into account national recommendations”

We work not to prove, but to improve!