Conducting Clinical Research

What'sthebestwaytogetstartedinclinicaltrials?HowdoIrecruitvolunteers?HowdoItraversetheethicalandpoliticalissuesinvolvedinconductingdrugtrialstoday?Withthetremendousdemandforclinicalinvestigators--thousandsofnewinvestigatorsareneededintheUnitedStatesalone--theanswerstothesequestionsisvital.Dr.JudyStoneanswersthesequestionsandmoreinthisexperiencedandsuccessfulfirst-hand"viewfromthetrenches."Thebookrevealstheminefieldsandboobytrapstoavoidwhenenteringthisfield，summarizesthedrugdevelopmentprocess，describesthecomplexitiesofthemultipledisciplinesandpeoplethatneedtocometogethertosuccessfullybringadrugthroughtrial，FDAapprovalandtomarket.Thebookdetailsthebestpracticesinvolvedincarryingoutastudyfromlandingyourfirststudyandnegotiatingwithadrugcompanytorecruitingandtreatingvolunteers.Othertopicsincludenewregulationsaffectingresearch，subjectinjuryclauses，legalandpublicationlandmines，theuniqueneedsofdeviceandvaccinetrials，culturalcompetencyandhealthliteracy，theimpactofHIPAAonU.S.research，andhowtosurviveaudits."Successfullycovers...clinicaltrials.Practicalconsiderations...substantialbackgroundandresourceinformation...fillsanimportantneed."AnnalsofInternalMedicine