Study types: the shift we saw that may be here long-term
Prior to the pandemic, most studies were on-site, with decentralized trials being a more novel concept. However, during the pandemic, some trials remained on-site while others moved to a hybrid model and we saw an increase in interest in decentralized trials. Depending on the protocol, we can see a future of hybrid models.
Are efficacy endpoints impacted? Depending on the study design, it may be of interest to exclude subjects who have had COVID-19, especially with potential residual effects confounding product efficacy. In other cases, including only vaccinated participants may reduce potential SAEs. It truly depends on the research question and the study product.
Options for Sponsors
Part of this strategy includes offering customizable solutions based on project scope and Sponsor risk tolerance. For example, one of our Sponsors has chosen to do rapid testing on trial participants if symptoms occur during the study, or every two weeks otherwise, for the duration of the study.
In the following video, Nutrasource's VP of Clinical Design and Delivery, Joshua Baisley, shares which operational changes were made in response to the pandemic in order to keep the trial running smoothly.