In most countries, regular care will be one of the first things to re-start post-Covid-19. With that, some of our clinical trials can re-start as well. We have discussed the re-start of trial recruitment with a lot of sites for a lot of studies in different countries and indications. This resulted in 4 pointers, for you to ensure the re-start of your trials and trial recruitment is as smooth as possible.
Of course, patient safety is key and postponing your study and/or study recruitment due to COVID-19 was required in many cases. But with the situation stabilizing in a lot of countries we need to consider if restarting our trial is possible. Some populations might be more at risk of staying at home than when they go to the hospital to receive their care and start/continue their trial. If your site(s) is(are) ready to re-start and they indicate they can receive the patients in a safe manner give them the opportunity to re-start your trial. As there can be major differences between countries and even between sites in a country, consider strategizing on a site level instead of on a country or study level.
Discuss upscaling possibilities with your sites. Are there any strategies to be added to the site's own recruitment activities? Perhaps some lost time can be made up. A multi-method recruitment strategy has proven to be very successful.
A lot can be done in preparation to optimize recruitment after the (re-)start. This is an ideal time to work on new/additional materials and the CEC/IRB submission. With all materials and approvals in place before the re-start, the sites can (re-)start study enrollment as soon as they are ready.
Probably this does not need to be said, but most of your sites have gone through a very stressful period. Please give them the time to get back to their routine. Discuss with your sites when they are really ready. You do not want to push sites to start recruitment when the sites are not entirely ready.
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