Clinical Epidemiology and Clinical Research – Pubrica

1. CLINICAL EPIDEMIOLOGY AND CLINICALRESEARCH An Academic presentationby Dr. Nancy Agens, Head, Technical Operations, Pubrica Group: www.pubrica.com Email:sales@pubrica.com

2. Today'sDiscussion Outline Inbrief What is Done in ClinicalEpidemiology Three Kinds of Diseases in Clinical Epidemiology Types of ClinicalResearch Four Phases of Clinical Research Conclusion

3. InBrief Clinical epidemiologyaims at preventing, detecting and treating diseases in an efficient manner. Clinical epidemiology focuses on medicines to improve health, especially in the present world, when individuals are encouraged to take care of their own health. Either a patient population could be chosen or some other community based population can also be considered which has the conventional numerator and denominator values of an epidemiologicalstudy.

4. What is Done in ClinicalEpidemiology The image given below illustrates what is done in clinicalepidemiology: Figure 1: Distribution and Determinants ofDiseases in HumanPopulation Contd..

5. The distribution and determinants of diseases in human population is investigated in these studies and clinical epidemiology serves as the right tool in thisrespect. Clinical epidemiology cannot be considered as an independent science because several skill sets are required in this field such as biostatistics, health social science and clinicaleconomics. A gold standard testing procedure is used in clinicalepidemiology. Results are the strength of relationship between two events which are measured through ratios, rates and proportion tests in clinicalepidemiology. This relationship data is presented in a table wherein the number of false positive and true positive diagnostic test results isvisualized. Contd..

6. Figure 2: False Positive and True Positive Diagnostic TestResults Contd..

7. Figure 3: Illustrating Clinical Epidemiology Study Results ofPatients Suffering from Covid-19 in Wuhan,China Contd..

8. Three Kinds of Diseases in ClinicalEpidemiology Endemic disease - it affects the population at a relatively constant and expected rate within a specific region. The spread of pathogens and vectors, which are the reservoirs of disease is the main cause of an endemic disease. Example includes Malaria inAfrica. Epidemic disease -the population is affected at an unusually fast or unexpected rate. It occurs due to the increase in infectivity of a pathogen, poor living conditions such as crowded areas and improper sanitation systems. Example includes Ebola fever in West Africa. Pandemic - it is defined as a worldwide epidemic, the reasons being global trade and worldwide travelling and the increased infectivity of pathogens due to antigenic shift and gene mutations. Example includesCovid-19.

9. Types of ClinicalResearch Treatment Research : It involves an intervention such as medication, psychotherapy, new devices, new approaches to surgery and radiationtherapy. Prevention Research: Finds out better ways to prevent the development or the return of diseases. Medicines, vitamins, vaccines, minerals and lifestyle changes are usually studiedhere. Diagnostic Research: This refers to the practice to look out for better ways for the identification of a particular disorder orcondition Contd..

10. Screening Research: It aims to find the best possible ways for the detection of particular disorders or typical healthconditions Quality of Life Research: This explores ways to improve comfort levels and the quality of life for individuals suffering from a chronicillness Genetic Studies: These studies aim to improve the prediction of disorders through identification and understanding of the relationship between genes and illhealth. Epidemiological Studies:They seek to identify the patterns, causes and control of disorders in different groups ofpeople. Contd..

11. Given below is an illustration of clinical researchstudy results on the causes, clinical manifestation, epidemiology, control and prevention of Covid-19 at the outbreak of thedisease: Figure 4: Illustrationof Clinical Research StudyResults

12. Four Phases of ClinicalResearch Clinical research involves conducting of clinical trials. These are done in fourphases: Phase I: An experimental drug or treatment is tested in a small group of people for the first time. The safety of treatment is determined by the researchers and they suggest a safe dosage range of the drug, with the identificationof sideeffects Phase II :The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate itssafety Phase III:The experimental drug or treatment is given to large groups of people. The effectiveness is confirmed, side effects are monitored, and these are compared to commonly usedtreatments. Phase IV: Post marketing studies are conducted after a treatmentis FDA approved. It provides additional information about the risks, benefits and best usage of the drug ortreatment.

13. Conclusion The factors considered in a clinical research study include age, gender, underlying disease and healthhistory. Clinical trials are carried out in hospitals, clinics, individual physician’s chambers, university health centres and community health centres, and patient privacy is essentially maintained during any clinicaltrial.

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