Clinical & Global Health Research Dr. Reza Nassiri MSU Institute of International Health COSGP Fall Quarterly Meeting OMED 2010, San Francisco, CA Monday, October 25, 2010

Clinical & Global Health Research This presentation: MSU Institute of International Health (MSU-IIH) Intro to Clinical Research 3. Global Health Research Opportunities

MSU Institute of International Health “Through multidisciplinary power of MSU academic and research tools, develop and implement human security approaches (Agriculture, Food Science, and Health) to addressing the challenges of global health.”

Institute of International Health Mission The IIH is a focal point at MSU for facilitating faculty and student international multidisciplinary health research and academic interests (health & medicine).

Institute of International Health Mission 2. The IIH works with health-related colleges, as well as with social, agricultural, and environmental scientists, nutritionists to foster and coordinate research, education, and development at the global level.

Institute of International Health Mission 3. The IIH collaborates with MSU-affiliated hospitals throughout the State of Michigan that are used for clinical training of MSU medical students.

Institute of International Health Mission 4. The IIH addresses health needs and problems of the world and serves as a center for health information exchange in the areas of: Social inequities & health Zoonotic diseases HIV/AIDS TB Environmental health Malaria Dengue fever Nutrition Global health policy issues

MSUCOM International Electives/Medical Missions Organizing international conferences in health & medicine, joint academic programs, and health development projects with international partners Global health organizations (eg., WHO, WHA) Global professional student organizations (eg., IFMSA)

International Elective Program Objectives: To expose MSUCOM students to various cultures. To offer students opportunity to see pathologies, which are uncommon in the United States. To enhance student’s clinical competencies and medical knowledge.

Health Exposure Trip Dominican Republic

Health Exposure Trip Dominican Republic

Health Exposure Trip Dominican Republic

International Physician Training in HIV Medicine

International Partners East London, South Africa Cecilia Makiwane Hospital Frere Hospital

International Partners ARNAS Civico Hospital, Palermo, Sicily

International Partners ARNAS Civico Hospital, Palermo, Sicily, Italy 4th year medical student clinical electives. Clinical/translational research Development of graduate health programs

International Partners Other Partners Australia New Zealand United Kingdom Germany Greece Egypt Brazil Turkey Mexico Haiti

CLINICAL RESEARCH

PERSIA

Clinical Research Avicenna (980-1037) Introduced experimentation into medicine and the idea of clinical trail. Avicenna’s tomb in Hamadan, IRAN

Clinical Research Avicenna (980-1037) TB Diabetes

Clinical Research Avicenna (980-1037) TB Diabetes

Avicenna: The Canon of Medicine The drug must be free from any extraneous accidental quality. It must be used on a simple, not a composite, disease. The drug must be tested with two contrary types of diseases, because sometimes a drug cures one disease by its essential qualities and another by its accidental ones.

Avicenna: The Canon of Medicine The quality of the drug must correspond to the strength of the disease. For example, there are some drugs whose heat is less than the coldness of certain disease, so that they would have no effect on them. The time of action must be observed, so that essence and accident are not confused.

Avicenna: The Canon of Medicine The effect of the drug must be seen to occur constantly or in many cases, for if this did not happen, it was an accidental effect. The experimentation must be done with the human body, for testing a drug on a lion or a horse might not prove anything about its effect on man!

What is Clinical Research? Clinical research (CR) refers to research conducted with human beings, including studies of specimens collected from specific patients. CR encompasses: Some laboratory research on the mechanisms of human disease Translational research (in which lab research and clinical activities are closely aligned) Clinical trials of preventive & therapeutic strategies Epidemiology Behavioral research Health services and outcome research

Conducting Clinical Research Academic qualification DO/PhD DO/MPH DO/MS Scientific qualification Cell & molecular Biostatistics Research methods Experience working in a research lab or conducting a research project

Clinical Research Guide Step 1: Develop an idea and formulate a hypothesis Coming up with an innovative idea is the first step. The idea should be focused (Start Small!), feasible, thought-provoking and contribute new information to the medical knowledge base. A research hypothesis should then be formulated. Based on your hypothesis, a list of specific aims can be developed to test your hypothesis.

Clinical Research Guide Step 2: Perform a thorough literature review To learn about other ongoing and completed research in your area To ascertain that your hypothesis has not been tested already by other researchers To build your case for funding requests

Clinical Research Guide Step 3: Search for funding opportunities Institutional seed money NIH Foundations International health organizations Health ministries Philanthropists Alumni

Clinical Research Guide Step 4: Develop a strong research team A proposal can be significantly strengthened by collaboration with other institutions. Having well qualified collaborators with complementary skills and experience will further strengthen your grant proposal.

Clinical Research Guide Step 5: Apply for a grant PI Co-PI Specific aims, goals, and objectives What the study is going to achieve in the short and long terms What will it bring to medicine e.g., new knowledge, new discovery, etc) Budget items

Clinical Research Guide Step 6: Institutional Review Board (IRB) for approval Request a lay individual (non-clinical or non-scientific) to read your IRB proposal If possible, be present at the IRB meeting or be available by phone Take advantage of the Pre-review system Plan ahead of time and check the IRB meeting schedule

Clinical Trials Treatment Prevention Early detection/screening Diagnostic Quality of life/supportive care

Clinical Trials Phase 1 How does the agent affect the human body? What dosage is safe? Phase 2 Does the agent or intervention have an effect on the diseases?

Clinical Trials Phase 3 Is the new agent or intervention (or new use of a treatment) better than the standard? Participants have an equal chance to be assigned to one of two or more groups.

Ethics of Clinical Research Aim to: Minimize the possibility of exploitation Ensure that the rights and welfare of subjects are respected while they contribute to the generation of knowledge

Ethical Framework Principles: Valuable scientific question Valid scientific methodology Fair subject selection Favorable risk-benefit evaluation Independent review Informed consent Respect for enrolled subjects J. Am. Med. Assoc., 2000; 283(20): 2701-11

GLOBAL EXAMPLES OF EMERGING AND RE-EMERGING INFECTIOUS DISEASES

GLOBAL EXAMPLES OF PEDIATRIC AND ADULT CANCERS

GLOBAL EXAMPLES OF GENETIC DISEASES AND DISORDERS

GLOBAL EXAMPLES OF ENDURING ENVIRONMENTAL DISASTERS

Global Health Priorities Prevent neonatal mortality Ensure healthier mothers and children Promote nutrition Reduce chronic diseases Cardiovascular Diabetes Stop AIDS pandemic

Global Health Priorities Stop the spared of tuberculosis Control malaria Combat tobacco use Environmental health Ensure equal access to high-quality care

Clinical Research in Haiti

Clinical Research in Haiti Dr. Coupet is the President of Doctors United for Haiti (DUFH). DUFH is an independent, academic non-profit organization developed to organize, coordinate, and thereby enhance healthcare systems and services in Haiti, including clinical res. DUFH has partnerships with Haitian health care professionals, hospitals and clinics throughout Haiti to help bring quality health care to Haitians through education and quality improvement.

Global Health Research MSU Institute of International Health is your passport! DUFH NIH CDC Institut Pasteur, Paris FIOCRUZ, Brazil

Thank you for your attention! Reza.Nassiri@hc.msu.edu GO GREEN!