Critical evaluation of the protocol early in the study will also identify if the inclusion criteria are too restrictive, proactively avoiding mid-study protocol amendments. For example, a study seeking hospital in-patients with a high oxygen saturation is unlikely to find them, as the national protocol for treating COVID-19 recommends primary care first and hospitalization only for more severe cases. Some protocols may require equipment that is not available at most sites; then, there should be up-front consideration for supplying that equipment or filling gaps (e.g., lack of cold storage for samples), potentially through third-party vendors.
Even when a study is ongoing, it’s not too late to address site selection and recruitment to ensure the success of a program. Our clinical teams use their experience from other disease outbreaks worldwide to inform the strategies for patient recruitment in ongoing COVID-19 trials. Download our brochure to learn more about our COVID-19 services.