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AssessingCOVID-19SymptomsinClinicalTrials
March26,2024
Theonsetofthecoronavirus,orCOVID-19,createdhavocacrosstheglobesinceits emergenceinDecember2019inWuhan,China,andfastspreadingpotential Thoughno longerconsidereda“publichealthemergency”(undersection319ofthePublicHealth ServicesAct),thevirusanditsnewstrainsarestillactivelycirculating.Thisrequires rigorousclinicaltrialstoevaluatedrugsandbiologicalproductsforitspreventionand treatment.
Trialsponsorsandinvestigatorscontinuetocarryoutclinicaltrialsforoutpatient preventionortreatmentforCOVID-19 Theseareconductedinadult&adolescent populationsthatexhibitCOVID-19symptoms.However,manychallengesexistwith respecttotheassessmentofsymptoms
U.S.FoodandDrugAdministration(FDA)issuedaguidanceaddressingthemeasurement andanalysisofCOVID-19-relatedsymptomsinoutpatientadultandadolescentsubjects Tomakethesponsorsaware,theFDAissuedrecommendationsdirectedtooptimizing trialdesignandfacilitatetimelyproductdevelopment.
Challenges relating to COVID-19 symptoms.
Withtheongoingclinicaltrials,challengespersistinassessingCOVID-19symptoms comprehensivelyandefficientlyincludingidentifyingmethodstoassessthevariancein
Fieldsmarkedwithan*arerequired
