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General steps of biomedical research

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A summary of the scheme of biomedical research.

Veröffentlicht in: Gesundheit & Medizin

General steps of biomedical research

  1. 1. Health Research Overview of the General Scheme of Ahmed Negida Fifthyearmedical Student,MBBCh candidate FacultyofMedicine, ZagazigUniversity,Egypt
  2. 2. 1. Developing a research idea Clinical Practice Reading Literature
  3. 3. 2. Searching the literature Textbooks Electronic databases Conference proceedings
  4. 4. 3. Formulating the hypothesis • Alternative hypothesis (H1) The hypothesis which the research is trying to prove. • Null hypothesis (H0) The hypothesis which the researcher is trying to disprove.
  5. 5. The drugs X is effectiveThe drugs X is not effective In a clinical trial to test the efficacy of drug (X) for the treatment of obesity, what are the null and alternative hypotheses?
  6. 6. 4. Planning phase (protocol writing) Which data can answer my research question? Which research design is suitable for my situation? Source of data? How can we collect these data? How will we analyze these data?
  7. 7. Research protocol  Systematic description of your research study  Must meet regulatory requirements to justify research and protecting research participants  Reviewed and approved by Ethics committee Research proposal  Statement of work (statement of purpose)  Must meet the requirements of the funding agency  Reviewed and approved by funding agency
  8. 8. Importance of research protocol  Planning is the most important step in research  Applying for ethical approval  Applying for funding (using a proposal)  International registration of research studies  PROSPRO for systematic review  Clinicaltrials.gov for clinical studies
  9. 9. 10.Discontinuation of the Study 11.Statistics 12.Quality Control and Assurance 13.Ethics 14.Data handling and Recordkeeping 15.Publication Policy 16.Project Timetable/Flowchart 17.References 18.Supplements/Appendices 1. Title Page (General Information) 2. Background Information 3. Objectives/Purpose 4. Study Design 5. Selection and Exclusion of Subjects 6. Treatment of Subjects 7. Assessment of Efficacy 8. Assessment of Safety 9. Adverse Events Components of research protocol
  10. 10. 5. Pilot study What? How? Why?
  11. 11. 6. Gaining Ethical approval Any research involving human subjects must be approved by appropriate ethics reviewers IRB (institutional review board) Ethics committee Why?
  12. 12. 7. Study implementation Screening Subjects’ enrollment Data Collection Data Entry Implementing the intervention
  13. 13. 8. Data analysis
  14. 14. 9. Writing the report (manuscript)
  15. 15. 10. Publishing your work