06 Jun 2020
Posted in Pharma
Clinical trials are adapting to a patient safety concerns over COVID-19
When clinical trials that were delayed since the beginning of the COVID-19 pandemic resume, it is highly probable that potential trial subjects will have a heightened sense of anxiety regarding COVID-19 and therefore may have reservations about participating, says GlobalData, a leading data and analytics company.
Mohamed Abukar, MSc, Clinical Trials Analyst at GlobalData, comments: “In order to combat these enrolment challenges, sponsors must ensure that patient safety remains paramount and that all available safety measures are implemented. This is especially likely in trials that require patients to be on site, as hospitals and clinics are thought to be areas where COVID-19 is highly prevalent, thereby reducing patient confidence and making them less inclined to enrol.
“Investigators must adapt to the new set of standards required for in-person trials by having a parallel set of measures to the trial protocol, including routine COVID-19 testing and an enhanced level of deep cleaning. Sponsors must also ensure that adequate personal protective equipment (PPE) is available.
“Providing subjects with safe transport to and from the site should also be considered where available, as a means of added incentive. All additional measures taken to prevent potential participants from contracting COVID-19 during their participation in a study must be relayed to the participants to increase their confidence in the safety of participating in trials.
“In addition, direct-to-patient drug delivery with remote monitoring could increase the participation of subjects and alleviate concerns of potential COVID-19 infection by in-person visits.”
Authorities such as the Food and Drug Administration (FDA) and Medicines and Heathcare Regulatory Agency (MHRA) have released new guidelines that promote the use of risk-mitigating strategies such as minimizing the number of participants at testing sites. Thus, a move towards decentralized clinical trials could mitigate the spread of COVID-19 while also being favorably regarded by the regulatory authorities.
Abukar concludes: “Moving forward, trial coordinators must take great care in selecting trial sites, giving priority to those that have previously utilized remote monitoring, as implementing new technology is typically a lengthy process. Trial coordinators should also look to increase the level of emotional support provided to patients to prevent feelings of frustration and isolation, which could ultimately lead to higher rates of patient drop out.”