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Clinical Research Practice

Clinical Research Practice. Epidemiology & Biostatistics 1. Epidemiology & Biostatistics 1. This course will introduce you to basic concepts of: the study of disease (who gets sick, where disease occurs, why people get disease, what factors affect disease).

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Clinical Research Practice

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  1. Clinical Research Practice Epidemiology & Biostatistics 1

  2. Epidemiology & Biostatistics 1 This course will introduce you to basic concepts of: • the study of disease(who gets sick, where disease occurs, why people get disease, what factors affect disease). • research methods for studying disease (how disease studies are designed). • how research can be used to improve public health. 2

  3. Objectives • Define epidemiology. • Identify the key roles of epidemiology in public health. • Given a study protocol, restate the question to be answered in your own words. • Differentiate between retrospective, cross-sectional and prospective studies. 3

  4. Objectives • Identify the advantages of prospective studies for answering a research question. • State the advantages of a randomized controlled study as compared to other types of study design. • Define the term evidence-based medicine. • List the steps in the evidence-based medicine process. 4

  5. Epidemiology? Doesn’t that have something to do with epidemics? 5

  6. What is Epidemiology? Epidemiologyis a branch of medical science that studies a group of people to see: • who has disease (young/old, male/female) • where is the disease occurring (urban/rural, Africa/Europe, etc.) • why people get disease (environmental, genetic, etc) • what is associated with disease and health(diet, other disease, environment, etc) With the goal ofpreventing disease and promoting goodhealth. 6

  7. Epidemiological StudiesExamine Public Health Issues • Surveillance of disease and general health – ongoing survey to see who gets sick. • Investigation of disease – study outbreaks of disease. • Analytic studies – how and why people get sick. • Evaluation of health programs – study effectiveness of public health programs. Photo courtesy of the Stop TB Partnership. 7

  8. Epidemiology Research Process • Define the hypothesis or question.State in detail what question you need answered. • Choose the appropriate study design.Decide the best way to answer research question. • Do research & collect data.Conduct investigations as appropriate for the study design and record all the information specified. • Analyze the data. Use biostatistics to examine data. • Report your findings. Share what you learn so that findings are used to improve public health. 8

  9. Epidemiology Research Process • Define the hypothesis or question.State in detail what question you need answered. • Choose the appropriate Study Design.Decide the best way to answer research question. • Do research & collect data.Conduct investigations as appropriate for the study design and record all the information specified. • Analyze the data. Use biostatistics to examine data. • Report your findings. Share what you learn with research community so that findings are used to improve public health. 9

  10. The Research Question The hypothesis or question to be answered is outlined in the study protocol and usually stated as an assumption to be tested. Sample Hypothesis: The annual risk of infection with M. tuberculosis in adults over 21 in the greater Worcester community of South Africa will be 4% or more. 10

  11. What Does It Mean? Break the hypothesis down into parts: 11

  12. What Do You Think This Means? The incidence of TB among neonates (newborn infants up to a month old) in multiple sites from South Africa and India in an actively monitored group will be estimated to be at least two-times greater than in the group that is not actively monitored. Photo courtesy of Aeras Global TB Vaccine Foundation. 12

  13. What Do You Think It Means? Break the hypothesis down into parts: During the 2 year study, the incidence of TB among neonates (newborn infants up to a month old) in multiple sites from South Africa and India The number of new cases of TB that occur in newborns participating in the 2-year study in South Africa and India in an actively monitored group will be estimated to be at least two-times greater than in the group that is not actively monitored. will be 2 times greater in the group that is tested regularly for TB than the group not tested regularly for TB. 13

  14. Your Turn In the Boland Overberg region Babies vaccinated with BCG by two different methods will have the same rate of TB until 2 years of age, with 2.5% infected with TB in both groups. 14

  15. Epidemiology Research Process • Define the hypothesis or question.State in detail what question you need answered. • Choose the appropriate Study Design.Decide the best way to answer research question. • Do research & collect data.Conduct investigations as appropriate for the study design and record all the information specified. • Analyze the data. Use biostatistics to examine data. • Report your findings. Share what you learn with research community so that findings are used to improve public health. 15

  16. How Will The Question Be Answered? • Retrospective Study:Collect data from the past. • Cross-sectional Study:Collect data at the present point in time. • Prospective Study:Collect data from start of the study & follow into the future. 16

  17. Retrospective Study or Case-Control Study Why do people have lung cancer? Was smoking a factor? • Retrospective study design looks backwards in time, selecting patients who have lung cancer and asking how much they smoked. • Since lung cancer takes decades to develop, this study design offers a quicker way to get an answer. 17

  18. Retrospective Study Design Asks… What were people exposed to in the past? Advantages • Relatively quick and easy to conduct study. • Allows a look at the relationship between disease and other factors. Disadvantages • Difficult to measure exposure to disease accurately. • Unable to conclude what factors cause disease. • Information can be biased when participants recall past events inaccurately. 18

  19. Cross-Sectional Study Design What is the current prevalence of diabetes? What factors affect diabetes? • Cross-sectional study design provides a current picture of how many people have diabetes. • In this type of study design you collect information about who has diabetes and other factors like health status, weight, economic status, environment, that could be linked to diabetes. 19

  20. Cross-Sectional Study Design Asks… How much disease is there now? Advantages • Relatively quick and easy to conduct study. Disadvantages • Will not show trends of disease over time. • Allows for association of disease factors, but does not allow one to determine cause-effect relationship. 20

  21. Prospective Study Design What is the affect of lead paint exposure? • Prospective study design provides a way to examine people from a known point (exposed or not exposed) and follow them forward in time to find out what happens. • It allows one to watch cause and effect as it develops over a period of time. 21

  22. Prospective Study Design Asks… What happens over time after an intervention or exposure occurs? Advantages • Allows an association of cause and effect. • Permits a precise measurement of exposure and disease diagnosis. • Minimizes recall bias. Disadvantages • Takes a lot of time. • Expensive to conduct. 22

  23. Why Is A Prospective Study Better? • Allows one to distinguish between cause and effect of factors affecting disease. • Can control exposure/intervention (dose, route, frequency) • Ensures that exposure/intervention comes before disease. • Permits a precise measurement of exposure and disease diagnosis. • Regulate handling of interventions. • Use same methods for diagnosing disease. 23

  24. The Best Way To Conducta Prospective Study A Randomized Controlled Trial is the most reliable way to set up a study to ensure valid research results by: • Assigning participants to study groups arbitrarily to avoid bias. • Comparing experimental groups to a control group receiving a standard intervention. 24

  25. Epidemiology Research Process • Define the hypothesis or question.State in detail what question you need answered. • Choose the appropriate Study Design.Decide the best way to answer research question. • Do research & collect data.Conduct investigations as appropriate for the study design and record all the information specified. • Analyze the data. Use biostatistics to examine data. • Report your findings. Share what you learn with research community so that findings are used to improve public health. 25

  26. Doing the Research • Research and data collection methods will vary according to the requirements of the study design. • Research for an Epidemiology study can be very similar to clinical research. • GCP and GLP guidelines should be followed to protect participants and ensure valid and reliable results. 26

  27. Epidemiology Research Process • Define the hypothesis or question.State in detail what question you need answered. • Choose the appropriate Study Design.Decide the best way to answer research question. • Do research & collect data.Conduct investigations as appropriate for the study design and record all the information specified. • Analyze the data. Use biostatistics to examine data. • Report your findings. Share what you learn with research community so that findings are used to improve public health. 27

  28. Analyze Data Using Biostatistics • To analyze data we use statistics to interpret what is seen. • Put simply, biostatistics is statistics applied to biological or medical questions. • Biostatistics is the application of statistical techniques to scientific research in health-related fields and the development of new tools to study these areas. 28

  29. Biostatistics and Epidemiology • Biostatistics is an indispensable tool to help epidemiologists improve health and reduce illness. • Biostatisticians design studies, analyze data and create methods to attack research problems as diverse as: • the determination of major risk factors for heart disease, lung disease and cancer. • evaluation of potential environmental factors harmful to human health, such as tobacco smoke, asbestos or pollutants . 29

  30. Epidemiology Research Process • Define the hypothesis or question.State in detail what question you need answered. • Choose the appropriate Study Design.Decide the best way to answer research question. • Do research & collect data.Conduct investigations as appropriate for the study design and record all the information specified. • Analyze the data. Use biostatistics to examine data. • Report your findings. Share what you learn with research community so that findings are used to improve public health. 30

  31. Using Results From Epidemiology Studies Evidence-based medicine uses results from epidemiology studies and other research to good use… improving public health and providing the best care to patients. Photo courtesy of Aeras Global TB Vaccine Foundation. 31

  32. Using Research Results toImprove Health and Health Care Evidence-Based Medicine (EBM) is the process of systematically reviewing clinical research findings and using the most significant results to aid the delivery of optimal healthcare to patients. Photo courtesy of the Stop TB Partnership. 32

  33. When you are sick… How does a doctor or nurse find out what causes your sickness? How does the doctor or nurse decide on the best treatment for you? How DoesEvidence-Based Medicine Work? Photo courtesy of the Stop TB Partnership. 33

  34. How Are Decisions MadeAbout Diagnosis & Treatment? Most doctors and nurses make decisions based on: • what was learned during training. • previous personal experience. • traditional practices and approaches. • advice from experts or textbooks. • other factors, such as cost, time and personal prejudice. 34

  35. A Better Way to Treat Patients: Evidence-Based Medicine Process When treating patients, the doctor or nurse: • Defines the hypothesis or question.Thinks in detail what needs to be answered related to a condition or intervention strategy. • Looks for research & other data.Search in current research findings for guidelines and information needed to answer the question. • Analyzes the data. Critically evaluate evidence in clinical research results looking for the most significant findings. • Uses evidence to treat patients.Draw conclusions and use interventions based on research findings and best practices. 35

  36. Asking a specific question about the best treatment or intervention. Searching for best evidence in available journals, etc. Evaluating available evidence and making a judgment on best course of action. Treating the patient based on the evidence. Evaluating the success. Back In the Clinic… Doctor or nurse makes decisions based on evidence from clinical research by: Photo courtesy of the Stop TB Partnership. 36

  37. Practical Evidence-Based Medicine Approved guidelines from expert medical groups, simplify the process by providing evidence-based summaries of latest research data. * Typical Evidence Ratings on Guidelines: I = randomizedcontrol trialII = trial data not randomizedIII = expert opinion A = Preferred B = Acceptable alternative C = Use when A & B can’t be given E = Should never be given 37

  38. How Does It Work? Example From a Current Study • Define the hypothesis or question.The rate of TB in infants will be the same regardless of the method used to administer the BCG vaccine. • Do research & collect data.5,500 infants received BCG vaccine by method 1, 5,500 by method 2. TB rates are being monitored to see if there is a difference in the rate of TB in the two groups. • Analyze the data.TB rates monitored over 2-4 years. Results analyzed to determine effectiveness of methods. • Use the information to treat patients.Results will be used to select vaccination method for new TB vaccines under development by Aeras. 38

  39. Review • Epidemiology is a branch of medical science that studies a group of people to see who has disease, how much disease they have and why they have disease. • Typical studies for epidemiology include surveillance of disease, investigation of a disease outbreak, analytic studies of disease patterns, evaluation of public health programs. 39

  40. Review • Interpreting a study hypothesis into plain English requires breaking it down into parts. • Study design is a critical step in the process. It ensures you get the right information to answer your research question. • Three common study designs are: • Retrospective - collect data from the past. • Cross-sectional – collect data from the present. • Prospective – collect data from the present into the future. 40

  41. Review • Prospective studies yield the best results because it allows for more precise and unbiased results. • A randomized controlled study is the best method for conducting a prospective study with convincing results. • Evidence-based medicine (EBM) is the process of using clinical research results to deliver the best possible healthcare to patients. 41

  42. Epidemiology & Biostatistics 2 This presentation is produced by Aeras Global TB Vaccine FoundationSM in collaboration with the University of Cape Town and the South African Tuberculosis Vaccine Initiative. A special thanks to Professor Greg Hussey, Dr. Tony Hawkridge, MBChB, Dr. Hassan Mahomed, Marie Buchanan, Marijke Geldenhuys, MSHS CRA, Marwou De Kock, B.Tec., Dr. Sylvia Silver, D.A., Jen Page, M.Ed. Dr. Larry Geiter, PhD, and Peggy Goetz, MPH, for their contributions and support for this presentation. 42

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