DOC PREVIEW
Rice BIOE 301 - Lecture Notes

This preview shows page 1-2-3-19-20-38-39-40 out of 40 pages.

Save
View full document
View full document
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience
View full document
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience
View full document
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience
View full document
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience
View full document
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience
View full document
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience
View full document
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience
View full document
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience
Premium Document
Do you want full access? Go Premium and unlock all 40 pages.
Access to all documents
Download any document
Ad free experience

Unformatted text preview:

BIOE 301Overview of TodayREVIEW OF LAST TIMEProgression of Heart DiseaseHeart Failure ReviewWhich one is a healthy heart?Slide 7CLINICAL TRIALSTake-Home MessageSlide 10Slide 11Types of Clinical StudiesTypes of Clinical TrialsSingle and Two Arm StudiesPhases of Clinical TrialsCLINICAL TRIAL DATA AND REPORTINGExamples of Biological DataBiological VariabilityDescriptive StatisticsExample: Blood PressureEXAMPLE: ABIOCOR TRIALClinical Trial of AbioCorSlide 23Slide 24Consent FormEXAMPLE: VITAMIN EThe StudyFollow-UpPLANNING A CLINICAL TRIALSlide 30Planning a Clinical TrialExample – Planning a Clinical TrialDesign ConstraintsSample Size CalculationTypes of Errors in Clinical TrialSlide 36How do we calculate n?Drug Eluting Stent – Sample SizeHow to Get InvolvedAssignments Due Next TimeBIOE 301Lecture Twenty:Clinical TrialsMike [email protected] of TodayReview of Last Time (Heart Disease)What is a Clinical Trial?Clinical Trial Data and ReportingClinical Trial Example: Artificial HeartClinical Trial Example: Vitamin EPlanning a Clinical TrialREVIEW OF LAST TIMEProgression of Heart DiseaseHigh Blood PressureHigh Cholesterol LevelsAtherosclerosisIschemiaHeart AttackHeart FailureHeart Failure ReviewWhat is heart failure?Occurs when left or right ventricle loses the ability to keep up with amount of blood flowhttp://www.kumc.edu/kumcpeds/cardiology/movies/sssmovies/dilcardiomyopsss.htmlHow do we treat heart failure?Heart transplantRejection, inadequate supply of donor heartsLVADCan delay progression of heart failureArtificial heartWhich one is a healthy heart?Heart Failure Heart FailureHealthy Heart Atrial Fibrilationhttp://static.howstuffworks.com/gif/artificial-heart-abiocor-diagram.gif http://www.ps-lk3.de/images/ABIOCOR.JPGCLINICAL TRIALSTake-Home MessageClinical trials allow us to measure the difference between two groups of human subjectsThere will always be some difference between selected groupsBy using statistics and a well designed study, we can know if that difference is meaningful or notScience of Understanding DiseaseEmerging Health TechnologiesPreclinical TestingClinical TrialsAdoption & DiffusionAbandoned due to:• poor performance• safety concerns• ethical concerns• legal issues• social issues• economic issuesBioengineeringEthics of researchCost-EffectivenessClinical StudiesEpidemiologicClinical TrialsObservationalControlledTwo-ArmSingle-ArmTypes of Clinical StudiesEpidemiologic - Hypothesis GenerationObserve a group of patients and look for common factorsAIDS in the 1980sDr. Snow and the Broad St. PumpClinical Trial - Hypothesis TestingDetermine the difference, if any, between two groups of patientsTypes of Clinical TrialsObservational StudiesObserve two groups already existing, and review data to determine differing factors between groupsEx. What behaviors are prevalent in lung cancer patients but not in those without the diseaseProblems – Bias, and lack of controlControlled StudyIntroduce difference between two selected groupsSingle and Two Arm StudiesSingle-Arm StudyGive treatment to all patientsCompare outcome before and after treatment for each patientCan also compare against literature valueTwo Arm StudySplit patients in trial into a control group and an experimental groupCan blind study to prevent the placebo affectPhases of Clinical TrialsPhase IAssess safety of drug on 20-80 healthy volunteersPhase IIDrug given to larger group of patients (100-300) and both safety and efficacy are monitoredPhase IIIVery large study monitoring side affects as well as effectiveness versus standard treatmentsPhase IV (Post-Market Surveillance)Searches for additional drug affects after drug has gone to marketCLINICAL TRIAL DATA AND REPORTINGExamples of Biological DataContinuously variableCore body temperature, height, weight, blood pressure, ageDiscreteMortality, gender, blood type, genotype, pain levelBiological VariabilityVariabilityMost biological measurement vary greatly from person to person, or even within the same person at different timesThe ChallengeWe need some way of knowing that the differences we’re seeing are due to the factors we want to test and not some other effect or random chance.Descriptive StatisticsModeMost common valueMeanStandard Deviationn1iinxxn1i2n)x(xσExample: Blood PressureMeasurementGet into groups of 4 and take each others blood pressure for the next 5-10minReportingIn those same groups, calculate the mean, mode and standard deviation of the classAnalysisIs the data normally distributed?Is there a difference between sides of the classroom?Does it mean anything?EXAMPLE: ABIOCOR TRIALClinical Trial of AbioCorGoals of Initial Clinical TrialDetermine whether AbioCor™ can extend life with acceptable quality for patients with less than 30 days to live and no other therapeutic alternative To learn what we need to know to deliver the next generation of AbioCor, to treat a broader patient population for longer life and improving quality of life.Clinical Trial of AbioCorPatient Inclusion Criteria (highlights)Bi-ventricular heart failure Greater than eighteen years old High likelihood of dying within the next thirty daysUnresponsive to maximum existing therapies Ineligible for cardiac transplantation Successful AbioFit™ analysis Patient Exclusion Criteria (highlights)Heart failure with significant potential for reversibility Life expectancy >30 days Serious non-cardiac disease Pregnancy Psychiatric illness (including drug or alcohol abuse) Inadequate social support systemClinical Trial of AbioCorClinical Trial EndpointsAll-cause mortality through sixty days Quality of Life measurementsRepeat QOL assessments at 30-day intervals until death Number of patients Initial authorization for five (5) implants Expands to fifteen (15) patients in increments of five (5) if 60-day experience is satisfactory to FDAConsent FormLink to Consent Form:http://www.sskrplaw.com/gene/quinn/informedconsent.pdfLink to other Documents about lawsuithttp://www.sskrplaw.com/gene/quinn/index.htmlEXAMPLE: VITAMIN EThe StudyPilot StudyIn the early 1990’s, small study done which showed taking vitamin E reduced risk of heart diseaseRegularly taking high doses


View Full Document

Rice BIOE 301 - Lecture Notes

Documents in this Course
Load more
Download Lecture Notes
Our administrator received your request to download this document. We will send you the file to your email shortly.
Loading Unlocking...
Login

Join to view Lecture Notes and access 3M+ class-specific study document.

or
We will never post anything without your permission.
Don't have an account?
Sign Up

Join to view Lecture Notes 2 2 and access 3M+ class-specific study document.

or

By creating an account you agree to our Privacy Policy and Terms Of Use

Already a member?