1. Conducting Investigator-Initiated Research Lydia A. Bazzano, MD, PhD

2. What is Investigator-Initiated Research? Any type of research initiated by an investigator rather than a drug or device company, foundation or government agency Clinical research – involves humans – Human subjects protection

3. Why is Investigator-Initiated Research Important? Why do it? Drug and device companies fund a large part of biomedical research What about prevention? What about predictive factors? What about treatment decisions for a specific individual ? What about research that does not seek to change a drug or device indication?

4. A Special Case: Investigator-Initiated Trials (IIT) Clinical trials are not, and cannot be, designed to determine all of the potential uses for a medication. IITs expand knowledge, identify new ways of using existing treatment and expand knowledge on the safety and efficacy of treatment Cardiac Arrhythmia Suppression Trial

5. Steps to Getting Research Started at Ochsner: 1.Identify your topic, design your study, consult with biostatistician 2.Write your plan in a protocol 3.Determine if you need IRB approval - x83535 4.Register for ERSA, create submission, upload documents, submit 5.Once approved, implement your plan

6. Where do Questions Come From? From patient-centered routine clinical practice: – diagnosis “What do I have, doctor?” – etiology “Is it because I did X?” – prognosis “How long do I have?” – treatment or prevention “Will Y do me any good?” From new treatments or diagnostic tests “Are they better than what we have?” From physician and patient experiences “What causes quick consultations?”

7. FINER Criteria for Research Feasible – Adequate number of subjects,technical expertise – Affordable in time and money, Manageable in scope Interesting – Interesting to the investigator Novel – Confirms or refutes previous findings – Extends previous findings, Provides new findings Ethical Relevant – To scientific knowledge, clinical and health policy – To future research directions

8. Designing Research Don’t go it alone - Find collaborators Consult with mentors Consult with a biostatistician - estimate sample size, determine analysis methods

9. Writing a Protocol detailed protocol template that can be adapted is available https://ersa.ochsner.org in the Forms and Templates section

10. Outline of a Protocol a. Protocol Summary/abstract b.Introduction (Background and Rationale) c.Study Objectives (Hypotheses) d.Study Design Overview e.Subject Selection (Inclusion & Exclusion Criteria) f.Study Methods and Procedures g.Statistical plan – analysis/power h.Data handling and record keeping (confidentiality) i.Ethical Considerations (Risks/Benefits/Consent) j.References