The evolution of the coronavirus disease 2019 (COVID-19) pandemic and widespread community of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variants continues to present new challenges for early phase clinical trials and COVID-19 diagnostic strategies. Many regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to provide updated guidance on the operations of clinical trials during the pandemic. However, guidance is limited with respect to medical and scientific specific issues, such as COVID-19 diagnostics. Here we discuss, the challenges for early phase studies associated with COVID-19 diagnostics in the Omicron era and potential risk mitigation strategies in the face of continued widespread community transmission. We note how careful consideration and planning can help mitigating the risk of COVID-19 impacting the medical and scientific validity and patient safety in clinical trials. Clinical study design should consider mitigation strategies at the patient, investigator, and clinical research organization (CRO)/Sponsor level following evaluation of the overall for their specific study/investigational product and patient overall wellbeing. Specific language regarding COVID-19-related policies and procedures should be included in the study protocol. Special considerations should be taken for novel immunotherapeutics which may require interruption in the event of a subject developing COVID-19 or for investigative products that may have hazardous interactions with commonly prescribed anti-COVID-19 therapies. Moving forward, its essential for trials to remain adaptable to evolving nature of the pandemic.
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