Why Do Clinical Research

1、Why Do Clinical Research?,Satisfaction of answering important questions which will improve the health of our patientsStatus of researchersSkill advancementProfessional advancementSalary and Job Security,What is Research?,Research is the endeavor to discover new facts, procedures, methods, and techniques by the scientific study of a course of critical investigation,Clinical Research,Clinical research involves working with human subjects to answer questions relevant to their well-beingPatient orie

2、nted research is where the rubber meets the road!,How To Do Research,Start with defining the questionWrite down a clear aimDivide the problem into smaller, answerable questions,How To Do Research,Develop hypothesesDecide what data is needed to test the hypothesesRefine the above and check the line of thought,Good Research,CLEAREssential for both the problem and the answerACCURATEExactness and precision come from hard work and responsible effortRELIABLEIf repeated will the answer be the same?,Goo

3、d Research,OBJECTIVEThe researcher exposes all possible prejudices at the onset of the study design and strives to overcome themWill the research be untarnished by personal gain, biases, vested interests, etc?,Researcher Qualities,KnowledgeableObservantLogicalOpen-mindedHonest,MotivatedIndependentFlexibleCareful,Researcher Qualities,CuriousInquisitiveEager to learnSkepticalPerceptive,PersistentPatientOriginalCreative,Getting Started,Learn your subjectRead, Read, ReadStart general and then focusB

4、egin with the problem,Getting Started,Formulate the problem as a research questionReduce the question to a single unambiguous question that is well-defined and answerable,Stages in Creativity,SENSERealize the need for a studyPREPAREGather relevant informationINCUBATEThink through the problemILLUMINATEImagine possible solutionsVERIFYEvaluate the solutions you have generated,Hypothesis,Thesis is the position that you believe represents truthHypothesis is the foundation on top of which you build yo

5、ur thesis,Hypothesis,Hypothesis is a tentative construct to be proved or disproved according to the evidenceThe hypothesis is sometimes expressed as a null hypothesis,A Good Hypothesis Should:,Be testableConvey the nature of the relationship being testedState exactly what variables form this relationshipReflect all variables of interestBe formulated early on in the planning stage,Study Types,Will you test a hypothesis or describe a phenomenon?Observational LongitudinalCross-sectionalRandomized,

6、double-blind, parallel group, placebo controlled trial,Epidemiology vs RCT,Epidemiology allows the study of the real world and the development of hypothesis regarding disease statesRandomized, controlled trials allow the rigorous testing of hypothesis in a well characterized manner that is less real world in nature,Study Design,Study PopulationAgeGenderEthnicity/RaceDisease characteristicsExclusionsNumberStratificationRandomization,Human Subjects,The safety and rights of human subjects must be p

7、rotectedStudy DesignInstitutional Review BoardInformed consentData Safety Monitoring/Medical Monitors,Key Questions,What is the main purpose of the trial?What treatments will be used and how? What is the participant risk?What are the possible benefits?How will patient safety be monitored?,Key Questions,Are there alternative treatments?Who is sponsoring the trial?What is the participant burden?How long and where?What do the participants have to do?Will there be any discomfort even if there is no

8、risk?,Methods,Define methods carefullyDecrease variabilityCheck reliability/reproducibilityAre you testing what you think you are testing?,Methods,Try to walk through the study and consider as many likely scenarios as possible.Try to design in any variations in treatment or data collection that you think will occur before the study starts,Operationalize Concepts,Specify how you will repeatably and reliably measure the variables you are using to answer the questionAn operational definition specif

9、ies how your concepts will be observed and measuredThis should allow your research to be reproduced,Data,Data are the facts you measureThey should be carefully recorded in an unbiased mannerThey should be measured in a manner that minimizes random variationThey should be derived from the operational definitions you have developed,Data Validation,Do the data make sense?Look critically at the dataHighest and lowest valuesData entry errorsDistribution: Normal or skewedCheck selected data entries with original data forms,Data Interpretation,Do not interpret/analyze data until after study is completedDo not unblind subjects until the study is completed other than for safety reasonsDo not interpret/analyze data until after data has been validated and the data set closed,Data Interpretation,Use the research question and hypotheses to guide analysesUse a priori definitions for any sub-set analysesExploration of epidemiologic data sets is OK, but need to avoid data mining,

《Why Do Clinical Research》由会员lizhe****0001分享，可在线阅读，更多相关《Why Do Clinical Research》请在金锄头文库上搜索。