Research oriented medical education - the essentials:
Gespeichert in:
| Weitere Verfasser: | , , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Chandigarh, India
White Falcon Publishing
2023
|
| Ausgabe: | First edition |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis Klappentext |
| Beschreibung: | xxiv, 252 Seiten Illustrationen |
| ISBN: | 9781636408149 |
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| adam_text | Table of Contents Í J ^V- Ч иі 1. Madhav Deo P Máničkám and Sanjay Mehendale Nikhil Gupte Table of Contents ЛЦѴ» Introduction Physician-Scientists and MD-PhD MD-PhD and Developing Nations Moving Academy of Medicine and Biomedicine Research-Oriented Medical Education (ROME) Impact of Workshops Participants’ Feedback Study Designs in Clinical and Epidemiological Research 1. 2. 3. 4. 5. 6. 7. 3. · Research-Oriented Medical Education 1. 2. 3. 4. 5. 6. 7. 2. ill Introduction Research Question, Hypothesis and Objectives The Life-cycle of Research Types of Epidemiological Study Designs Critical considerations in relation to design, implementation and interpretation of various research studies Developing Clinical Research Protocols Summing up 1 1 1 2 3 3 6 7 9 9 11 11 15 24 28 29 Data Management and Biostatistics ЗО 1. 2. 3. 4. 5. 6. 7. 8. 9. зо 31 31 32 35 36 36 37 37 Data Management Types of Variables Measures of Data Summary Exploratory Analysis Normal Distribution Population and Sample Central Limit Theorem Testing of Hypothesis Common Statistical Tests
Table of Contents vi ♦ 4. 5. 6. 7. Roli Mathur Rita Mulherkar Madhuri Thakar Avinash Deo Ethics in Biomedical Health Research 42 1. Introduction 2. Historical Perspective 3. International and National Guidelines 4. General Principles 5. Ethics Committees 6. Conclusion 42 42 43 44 52 54 Commonly used Laboratory Procedures 56 1. 2. 56 63 Immunodiagnosis - The Tools 67 Introduction Types of Immunodiagnostic Assays Nature of Results Obtained from Elisa Immunofluorescence Test Lateral Flow Assay Chemiluminescent Immunoassays (CLIAs) Limitations of Immunodiagnosis for antibody detection 8. Flow Cytometry as Immunodiagnostic tool 9. Quality Control in Immunodiagnostics 10. Immunodiagnostics: Requirement of Collaboration from all arms of Healthcare 67 68 72 73 73 73 1. 2. 3. 4. 5. 6. 7. Implications of Information Technology to Medical Research 1. 2. 3. 4. 5. 6. 8. К Satyanarayana and Madhuri Somani Nucleic Acid Based Techniques Basic Techniques for Studying Proteins Outline Introduction to Information Technology Information lechnology in Modelling Information Technology in Data Management InformationTtechnology in Clinical Research Information Technology in Information Management Preparing Research Proposal to Seek Funds from Public Sector Entities 1. 2. 3. 4. 5. 6. 7. Background Funding Opportunities in India Planning the Proposal Project Format Statutory Requirements/Codal Formalities/ Declarations Writing Process Responding to Revisions/How to handle Rejection 74 74 78 78 80 80 80 82 83 85 87 90 90 91 92 93 104 105 106
♦ v։։ Table of Contents 9. Vani Srinivas and Prashant Mathur Writing a Research Protocol for Non Communicable Diseases 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 10. Renu Bharadwaj Mégha Joshi Shreerang Joshi Arun Bhatt 112 115 116 119 119 119 120 120 121 121 121 122 122 123 Introduction What, Where and How Before Writing Quantitative Study Qualitative Study The Basics of Scientific Writing Common Reasons for Rejection 125 126 127 129 133 135 Good Laboratory Practices Introduction Evolution of Regulatory Laws Essential Components of a Good Laboratory Designing Informed Consent Proforma 1. 2. 3. 4. 5. 6. 13. 109 in 112 125 1. 2. 3. 12. 109 The Art and Science of Scientific Writing 1. 2. 3. 4. 5. 6. 11. Overview Approach to NCD Research Domams of NCD Research (Figure 9.2) Types of NCD Research (Study Designs for NCD Research) Community Intervention Trials (CITs) Format ofNCD Research Protocol [9, 10] Ethical Considerations Administrative Approvals Budget Required Outcome Referencing Annexures Report Writing Sharing Results with Study Participants Dissemination Other Aspects of Research Conclusion Introduction History Medical Research Ethics Guidelines Informed Consent Process of Informed Consent Exceptions 137 137 137 138 142 142 142 143 144 146 147 Good Clinical Practice Ethical and Scientific Standard for Clinical Research Conduct 148 1. 2. 148 148 Introduction Evolution of 1CH-GCP
Table of Contents viii ♦ —3. 14. Priyanka Raichur and Vidya Mave Evolution of Indian GCP 4. 5. ICH-GCP Guidelines Responsibilities for GCP Compliance 6. 7. Essential documents Conclusions ___________________ Designing a Clinical Protocol I. 2 3 4. Introduction Need for Clinical Research Protocol Steps in Conducting a Research Study Essential Components of a Clinical Trial Protocol 5. Title Page for Clinical Protocol 6. Introduction of the Protocol Topic 7. Participant Enrolment and Withdrawal 8. Study Intervention 9. Study Procedures and Schedules 10. Safety and Adverse Event Reporting 11. Monitoring Procedures 12. Statistical and Analysis Plan 13. Source Documents and Access to them 14. Quality Management 15. Ethics/Protection of Participants 16. Data Handling and Record Keeping 17. Protocol Deviations 18. Publication and Data Sharing Policy 19. Study Administration 20. Conflict of Interest Policy 21. Literature References 22. Appendices 23. Publication and Registering a Clinical Protocol 15. 16. Shubha Phadke Avani Nadkarni Mulherkar 150 151 154 159 159 161 161 162 162 163 163 164 165 165 166 166 167 167 167 167 168 168 168 169 169 169 169 169 169 Genetics in Medicine 172 1. History of Medical Genetics 2. The Classification of Genetic Disorders 3. Clinical Presentation of Genetic Disorders 4. Diagnosis of Genetic Disorders 5. Treatment of Genetic Disorders 6. Genetic Counselling and Prenatal Diagnosis 7. Representative Cases 172 174 175 178 180 182 182 Molecular Medicine and Gene Therapy 185 I. 2. 3. 4. Small Molecule Inhibitors Monoclonal Antibodies Gene Therapy
Conclusions 185 190 192 195
Table of Contents 17. Nilima Kshirsagar ■փ· Drug Development 1. 2. 3. 4. 5. 6. 7. 8. 9. 18. Narendra Chirmule and Amitabh Gaur Vaccines Against Infectious Diseases 1. 2. 3. 4. 5. 6. 7. 19. Vikram Gota, Manjunath Nookala Krishnamurthy, Sharath Kumar Suresh Chari Introduction Vaccine Development - Key Immunological Concepts Vaccine Development Vaccines Approved or in Development in the Last Five Years Lessons Learned from Vaccine Development Vaccine against SARS-CoV-2 (COVID-19) Summary Indian Regulatory Scenario in Drug and Vaccine Development 1. 2. 3. 4. 5. 6. 20. Introduction History Steps in Drug Discovery and Development Process Challenges and Opportunities in Drug Development Opportunities Strategies to Overcome Challenges What is New? Clinical Trials Design and Analysis Conclusions Brief history Regulatory Bodies and Their Functions Drug Development Process Role of Regulatory Bodies in the Process of Drug Development Import of Drugs Waivers Power of Powerful Presentation 1. Introduction 2. Presentation 3. Butterflies in the Stomach 4. Stage Fright 5. Steps to Control Stage Fear 6. Important Steps while Making a Presentation 7. Evaluating or Looking for Feedback 8. Mie: Devil or Friend? 9. Tips for a Powerful Presentation 197 197 197 199 201 203 203 205 206 206 208 208 209 209 211 214 215 219 223 223 224 225 227 233 233 235 235 235 236 236 237 237 243 243 243 їх
RESEARCH ORIENTED MEDICAL EDUCATION Creative minds are evenly distributed irrespective of caste, creed or geography. However, research, the mother of innovations, is highly neglected, especially in the developing nations, where young minds are often knowledge-starved and hardly exposed to current research culture.The ROME (Research Oriented Medical Education), is a mobile, short duration, in-study program of mobile research workshops on advanced medical and biomedical topics, hosted in medical colleges all over India, developed by the Moving Academy of Medicine and Biomedicine, Pune, India. The topics covered are clinically oriented such as study designs, biostatistics, ethics and application of information technology in medical research, as well as commonly used immunology, protein and nucleic acid technologies. The book, which is based on ROME, is aimed at promoting research culture in young creative minds.
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| adam_txt |
Table of Contents Í J' ^V- ' Ч иі 1. Madhav Deo P Máničkám and Sanjay Mehendale Nikhil Gupte Table of Contents ' ЛЦѴ» Introduction Physician-Scientists and MD-PhD MD-PhD and Developing Nations Moving Academy of Medicine and Biomedicine Research-Oriented Medical Education (ROME) Impact of Workshops Participants’ Feedback Study Designs in Clinical and Epidemiological Research 1. 2. 3. 4. 5. 6. 7. 3. · Research-Oriented Medical Education 1. 2. 3. 4. 5. 6. 7. 2. ill Introduction Research Question, Hypothesis and Objectives The Life-cycle of Research Types of Epidemiological Study Designs Critical considerations in relation to design, implementation and interpretation of various research studies Developing Clinical Research Protocols Summing up 1 1 1 2 3 3 6 7 9 9 11 11 15 24 28 29 Data Management and Biostatistics ЗО 1. 2. 3. 4. 5. 6. 7. 8. 9. зо 31 31 32 35 36 36 37 37 Data Management Types of Variables Measures of Data Summary Exploratory Analysis Normal Distribution Population and Sample Central Limit Theorem Testing of Hypothesis Common Statistical Tests
Table of Contents vi ♦ 4. 5. 6. 7. Roli Mathur Rita Mulherkar Madhuri Thakar Avinash Deo Ethics in Biomedical Health Research 42 1. Introduction 2. Historical Perspective 3. International and National Guidelines 4. General Principles 5. Ethics Committees 6. Conclusion 42 42 43 44 52 54 Commonly used Laboratory Procedures 56 1. 2. 56 63 Immunodiagnosis - The Tools 67 Introduction Types of Immunodiagnostic Assays Nature of Results Obtained from Elisa Immunofluorescence Test Lateral Flow Assay Chemiluminescent Immunoassays (CLIAs) Limitations of Immunodiagnosis for antibody detection 8. Flow Cytometry as Immunodiagnostic tool 9. Quality Control in Immunodiagnostics 10. Immunodiagnostics: Requirement of Collaboration from all arms of Healthcare 67 68 72 73 73 73 1. 2. 3. 4. 5. 6. 7. Implications of Information Technology to Medical Research 1. 2. 3. 4. 5. 6. 8. К Satyanarayana and Madhuri Somani Nucleic Acid Based Techniques Basic Techniques for Studying Proteins Outline Introduction to Information Technology Information lechnology in Modelling Information Technology in Data Management InformationTtechnology in Clinical Research Information Technology in Information Management Preparing Research Proposal to Seek Funds from Public Sector Entities 1. 2. 3. 4. 5. 6. 7. Background Funding Opportunities in India Planning the Proposal Project Format Statutory Requirements/Codal Formalities/ Declarations Writing Process Responding to Revisions/How to handle Rejection 74 74 78 78 80 80 80 82 83 85 87 90 90 91 92 93 104 105 106
♦ v։։ Table of Contents 9. Vani Srinivas and Prashant Mathur Writing a Research Protocol for Non Communicable Diseases 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 10. Renu Bharadwaj Mégha Joshi Shreerang Joshi Arun Bhatt 112 115 116 119 119 119 120 120 121 121 121 122 122 123 Introduction What, Where and How Before Writing Quantitative Study Qualitative Study The Basics of Scientific Writing Common Reasons for Rejection 125 126 127 129 133 135 Good Laboratory Practices Introduction Evolution of Regulatory Laws Essential Components of a Good Laboratory Designing Informed Consent Proforma 1. 2. 3. 4. 5. 6. 13. 109 in 112 125 1. 2. 3. 12. 109 The Art and Science of Scientific Writing 1. 2. 3. 4. 5. 6. 11. Overview Approach to NCD Research Domams of NCD Research (Figure 9.2) Types of NCD Research (Study Designs for NCD Research) Community Intervention Trials (CITs) Format ofNCD Research Protocol [9, 10] Ethical Considerations Administrative Approvals Budget Required Outcome Referencing Annexures Report Writing Sharing Results with Study Participants Dissemination Other Aspects of Research Conclusion Introduction History Medical Research Ethics Guidelines Informed Consent Process of Informed Consent Exceptions 137 137 137 138 142 142 142 143 144 146 147 Good Clinical Practice Ethical and Scientific Standard for Clinical Research Conduct 148 1. 2. 148 148 Introduction Evolution of 1CH-GCP
Table of Contents viii ♦ —3. 14. Priyanka Raichur and Vidya Mave Evolution of Indian GCP 4. 5. ICH-GCP Guidelines Responsibilities for GCP Compliance 6. 7. Essential documents Conclusions _ Designing a Clinical Protocol I. 2 3 4. Introduction Need for Clinical Research Protocol Steps in Conducting a Research Study Essential Components of a Clinical Trial Protocol 5. Title Page for Clinical Protocol 6. Introduction of the Protocol Topic 7. Participant Enrolment and Withdrawal 8. Study Intervention 9. Study Procedures and Schedules 10. Safety and Adverse Event Reporting 11. Monitoring Procedures 12. Statistical and Analysis Plan 13. Source Documents and Access to them 14. Quality Management 15. Ethics/Protection of Participants 16. Data Handling and Record Keeping 17. Protocol Deviations 18. Publication and Data Sharing Policy 19. Study Administration 20. Conflict of Interest Policy 21. Literature References 22. Appendices 23. Publication and Registering a Clinical Protocol 15. 16. Shubha Phadke Avani Nadkarni Mulherkar 150 151 154 159 159 161 161 162 162 163 163 164 165 165 166 166 167 167 167 167 168 168 168 169 169 169 169 169 169 Genetics in Medicine 172 1. History of Medical Genetics 2. The Classification of Genetic Disorders 3. Clinical Presentation of Genetic Disorders 4. Diagnosis of Genetic Disorders 5. Treatment of Genetic Disorders 6. Genetic Counselling and Prenatal Diagnosis 7. Representative Cases 172 174 175 178 180 182 182 Molecular Medicine and Gene Therapy 185 I. 2. 3. 4. Small Molecule Inhibitors Monoclonal Antibodies Gene Therapy
Conclusions 185 190 192 195
Table of Contents 17. Nilima Kshirsagar ■փ· Drug Development 1. 2. 3. 4. 5. 6. 7. 8. 9. 18. Narendra Chirmule and Amitabh Gaur Vaccines Against Infectious Diseases 1. 2. 3. 4. 5. 6. 7. 19. Vikram Gota, Manjunath Nookala Krishnamurthy, Sharath Kumar Suresh Chari Introduction Vaccine Development - Key Immunological Concepts Vaccine Development Vaccines Approved or in Development in the Last Five Years Lessons Learned from Vaccine Development Vaccine against SARS-CoV-2 (COVID-19) Summary Indian Regulatory Scenario in Drug and Vaccine Development 1. 2. 3. 4. 5. 6. 20. Introduction History Steps in Drug Discovery and Development Process Challenges and Opportunities in Drug Development Opportunities Strategies to Overcome Challenges What is New? Clinical Trials Design and Analysis Conclusions Brief history Regulatory Bodies and Their Functions Drug Development Process Role of Regulatory Bodies in the Process of Drug Development Import of Drugs Waivers Power of Powerful Presentation 1. Introduction 2. Presentation 3. Butterflies in the Stomach 4. Stage Fright 5. Steps to Control Stage Fear 6. Important Steps while Making a Presentation 7. Evaluating or Looking for Feedback 8. Mie: Devil or Friend? 9. Tips for a Powerful Presentation 197 197 197 199 201 203 203 205 206 206 208 208 209 209 211 214 215 219 223 223 224 225 227 233 233 235 235 235 236 236 237 237 243 243 243 їх
RESEARCH ORIENTED MEDICAL EDUCATION Creative minds are evenly distributed irrespective of caste, creed or geography. However, research, the mother of innovations, is highly neglected, especially in the developing nations, where young minds are often knowledge-starved and hardly exposed to current research culture.The ROME (Research Oriented Medical Education), is a mobile, short duration, in-study program of mobile research workshops on advanced medical and biomedical topics, hosted in medical colleges all over India, developed by the Moving Academy of Medicine and Biomedicine, Pune, India. The topics covered are clinically oriented such as study designs, biostatistics, ethics and application of information technology in medical research, as well as commonly used immunology, protein and nucleic acid technologies. The book, which is based on ROME, is aimed at promoting research culture in young creative minds. |
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| spelling | Research oriented medical education - the essentials Editors: Madhav G. Deo, Renu Bharadwaj, Rita Mulherkar First edition Chandigarh, India White Falcon Publishing 2023 xxiv, 252 Seiten Illustrationen txt rdacontent n rdamedia nc rdacarrier Medizinstudium (DE-588)4038291-6 gnd rswk-swf Medizinische Ausbildung (DE-588)4169212-3 gnd rswk-swf Arzt (DE-588)4003157-3 gnd rswk-swf Arzt (DE-588)4003157-3 s Medizinische Ausbildung (DE-588)4169212-3 s DE-604 Medizinstudium (DE-588)4038291-6 s Deo, Madhav G. ca. 20./21. Jh. (DE-588)1290949026 edt Bharadwaj, Renu edt Mulherkar, Rita edt Digitalisierung UB Augsburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034167620&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Augsburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034167620&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext |
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| title | Research oriented medical education - the essentials |
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| title_full | Research oriented medical education - the essentials Editors: Madhav G. Deo, Renu Bharadwaj, Rita Mulherkar |
| title_fullStr | Research oriented medical education - the essentials Editors: Madhav G. Deo, Renu Bharadwaj, Rita Mulherkar |
| title_full_unstemmed | Research oriented medical education - the essentials Editors: Madhav G. Deo, Renu Bharadwaj, Rita Mulherkar |
| title_short | Research oriented medical education - the essentials |
| title_sort | research oriented medical education the essentials |
| topic | Medizinstudium (DE-588)4038291-6 gnd Medizinische Ausbildung (DE-588)4169212-3 gnd Arzt (DE-588)4003157-3 gnd |
| topic_facet | Medizinstudium Medizinische Ausbildung Arzt |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034167620&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034167620&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT deomadhavg researchorientedmedicaleducationtheessentials AT bharadwajrenu researchorientedmedicaleducationtheessentials AT mulherkarrita researchorientedmedicaleducationtheessentials |