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Clinical trial protocol writing

u2022The clinical study protocol is defined as the procedures by which clinical research is conducted<br>u2022A clinical study protocol should provide a clear clinical study design to meet the objective of the clinical trial<br>u2022tA defined protocol must address the proposed medical question and protect the safety and rights of the clinical trial participant/patients<br> To Continue Reading : https://bit.ly/2W5AgGu<br><br>Contact Us:<br>Website : https://bit.ly/33Fwsye<br>Email us: sales.cro@pepgra.com<br>Whatsapp: 91 9884350006<br>

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Clinical trial protocol writing

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  1. CLINICALTRIALPROTOCOL WRITING:CHALLENGES ANDGUIDELINES AnAcademicpresentation by Dr.NancyAgens,Head,TechnicalOperations, Pepgra Group:www.pepgra.com Email:pepgrahealthcare@gmail.com

  2. Today'sDiscussion OUTLINEOFTOPICS InBrief Introduction ChallengesinWritingClinicalProtocol GeneralGuidelinesin Writingthe Clinical ProtocolConclusion

  3. InBrief Theclinicalstudyprotocolisdefinedastheproceduresbywhichclinicalresearchisconducted.Aclinicalstudyprotocolshouldprovideaclearclinicalstudydesigntomeettheobjectiveofthe clinicaltrial.Adefinedprotocolmustaddresstheproposedmedicalquestionandprotectthesafetyandrightsoftheclinical trialparticipant/patients.

  4. Introduction Clinicaltrialsareaimedatevaluatingnewpharmaceuticaldrugs,medicaldevices, andsurgicalmaterials. Clinicaltrialsarealsoconductedindiagnosingdiseasesearlytopreventtheseverityofthediseaseconditions. Everynewfindingofmedicaldrugsanddevicesgoesthroughfourphasesofclinicaltrialstofindtheappropriatedosagevalueandthecorrespondingsideeffects. PhaseI:Theclinicaltrialexperimentswillbecarriedoutwithasmallgroupof participantstestthesafetyandsideeffectstofindtheaccuratedosagevalue. Contd..

  5. PhaseII:Testingtheeffectivenessandobtainpreliminarydataofcuringrateandstudytheshort-termsideeffects.PhaseII:Testingtheeffectivenessandobtainpreliminarydataofcuringrateandstudytheshort-termsideeffects. PhaseIII:Thedrugwillbetestedinalargegrouptocollectmoredataonsafety,effectiveness,sideeffectsrelatedtodosagerangewithdifferentagegroupsanddiseaseseverity. PhaseIV:Willbepermittedtocarryoutwithadiversepopulationforaprolongedperiodforadetailedstudy.

  6. ChallengesinWritingClinicalProtocol Theclinicaltrialprotocolisawell-definedprocedureofthestudy,anditmustprovideaclear&concisedesigntomeettheobjectiveofthestudy. Thecontributionsofmedicalexperts,regulatoryexperts,statisticians,pharmacokineticistsandoperationalexpertsaremandatoryinprotocoldevelopment. Writingawell-communicatedclinicaltrialprotocolisoftenchallenging,andInternationalCouncilforHarmonisationGoodClinicalPracticeprovidedcertainrecommendationlikewhatneedstobeincludedintheprotocolanditsstructure.

  7. GeneralGuidelinesinWritingtheClinicalProtocol 1.INTRODUCTION: Theintroductionmusthavedetailedliteraturereviewcoveringtheexistingtherapeuticoptionsandtestmethods. 2.OBJECTIVE: Thissectionshouldstatetheobjectiveintheform"SMART". Therearethreecategoriestheyareprimary,secondaryandexploratory. Primarywilldelivertheaimstoanswerclinicaltrialpurposedirectly. Secondarywillexplaintheassociatedactionswiththerationale. Contd..

  8. Exploratorywillstatethehypothesis-generatingobjectivesthatcanbeanalysedwithadditionalstudies.Exploratorywillstatethehypothesis-generatingobjectivesthatcanbeanalysedwithadditionalstudies. Figure1:Smart Contd..

  9. 3.POPULATION: Thetargetedpopulationwillbeusedforthetrialincludesthegeographicalregionandadetailedlistofinclusionandexclusioncriteriawhichspecifiesage,sex,BMI,etc. 4.ENDPOINTS: Itisdefinedasanindicatorinmeasuringabiologicalsample. Thereshouldbeanendpointwhichexactlymatchestheobjectiveofthestudyto ensurethatthecorrectvariablesaremeasured. 5.TRIALDESIGN: Theclinicaltrialdesignwillindicatetheparticipant'streatmentandthenumberofrequiredgroupsfortreatmentanddatacollections. Contd..

  10. 6.CONTROLGROUPS: Thissectionexplainsthecontrolgroupsandthetargetpopulationshouldbeclearlyidentifiedandjustified,andthecontrolgroupmustbealignedwiththeclinicaltrialdesignandobjective. 7.STATISTICALCONSIDERATIONS: Thissectionintheprotocolshouldexplaintherationaleforthecalculatedsamplesizewiththeclinicalandstatisticalassumptionsbasedontheprimaryendpoint. Weprovidestatisticiansupport,andwhenapplicableweofferothersupport,andwehaveexpertslikepharmacodynamicsexpertsandclinicalwritingexpert.

  11. Conclusion Theclinicalprotocolistheprocedurebywhichthetrial isconducted,andthewritingrequiresawideamountofassessmentonallconcepts relatedtothetrial. Pepgrahasunderstoodthecomplexityofdevelopingacomplete clinical trialprotocolwithexperts. Ourteam ofexpertswillthusprotectthescientificintegrityofthetrial andthesafetyoftheparticipants.

  12. ContactUs UNITEDKINGDOM +44-7424810299 INDIA +91-9884350006 EMAIL pepgrahealthcare@gmail.com

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