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HOW TO BECOME A CLINICAL RESEARCH ASSOCIATE<br>clinical research experience<br>CLINICAL RESEARCH ASSOCIATE CERTIFICATION<br>

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  1. An Introduction To Clinical Research 1 Copyright ccrpcourse.com Axilogy Consultants LLC

  2. What Is Clinical Research? q Research conducted on humans or human tissues that makes use of patient data. q Includes study of : ▪ Disease mechanisms ▪ Therapeutic interventions ▪ Epidemiology ▪ Clinical trials q Aimed at understanding human disease and improving human health q Interaction between researchers and patient data is a key feature. 2 Copyright ccrpcourse.com

  3. Definitions Patient-oriented research: Research conducted with human subjects (or on material of human origin) for which an investigator (or colleague) directly interacts with human subjects. This area of research includes: q Mechanisms of human disease. q Clinical trials. q q q q Outcomes and health services research. Therapeutic interventions. Development of new technologies. Epidemiologic and behavioral studies. 3 Copyright ccrpcourse.com

  4. Contd…… Doris Duke Foundation Research conducted with human subjects, including: q Studies on the etiology and pathogenesis of human disease. q Clinical trials. q Therapeutic interventions. q Epidemiological studies. Disease control research Investigates how scientific information can be efficiently applied in: q Prevention. q Early detection. q Early diagnosis. 4 Copyright ccrpcourse.com

  5. Contd…… National Clinical Research Summit Project ▪ ▪ Component of medical and health research Intended to produce knowledge valuable for : ➢ Understanding human disease ➢ Preventing and treating illness ➢ A continuum of studies involving : • Interaction with patients • Diagnostic clinical materials or data or populations in the following categories : q Disease mechanisms q Translational research q Clinical knowledge 5 Copyright ccrpcourse.com

  6. Contd…… q Detection q Diagnosis q Natural history of disease q Therapeutic interventions including clinical trials q Prevention and health promotion q Behavioral research q Health services research q Epidemiology q Community-based research q Managed care-based research 6 Copyright ccrpcourse.com

  7. Importance of Clinical Research v Enhances our understanding of human physiology and pathophysiology. v Translates basic research into medical care. v Informs and drives basic research. v Improves diagnostic tools and preventive care. v Improves human health. 7 Copyright ccrpcourse.com

  8. Clinical Trial Phases ➢ Phase I Trials ▪ First time test of intervention ▪ Small group : 20-80 ▪ Evaluation of safety ▪ Determination of appropriate dosage ▪ Identification of side-effects ➢ Phase II Trials ▪ Intervention to larger group : 100-300 ▪ Evaluate effectiveness ▪ Evaluate safety 8 Copyright ccrpcourse.com

  9. Clinical Trial Phases ➢ Phase III Trials ▪ Large group : 100-3000 ▪ Confirm effectiveness ▪ Monitor side effects ▪ Compare to other treatments ▪ Collect information for allowance on safe usage ➢ Phase IV Trials ▪ Post- marketing studies ▪ Determination of risk and benefit ▪ Optimal use of an intervention 9 Copyright ccrpcourse.com

  10. Accomplishments of Clinical Trials? q Research in human physiology and pathophysiology translates basic research into knowledge of disease mechanisms and medical therapeutics. q Clinical trials establish safety and efficacy of new interventions. q Epidemiological and behavioral research identify high risk populations with potential to benefits for ▪ Prevention ▪ Early detection ▪ Therapeutic intervention q Outcomes and health services research assess the health impact and cost-effectiveness of interventions. 10 Copyright ccrpcourse.com

  11. Accomplishments of Clinical Trials Linking HIV to AIDS q Basic research into DNA, viruses and retroviruses paved way for identification of first human retrovirus in cancer patients. q Clinical studies showed that cancer causing retroviruses exert similar effects to AIDS on the human immune system. q This helped scientists to identify HIV, a retrovirus in the same family as the cancer causing retroviruses, as the one responsible for the development of AIDS. 11 Copyright ccrpcourse.com

  12. Accomplishments of Clinical Trials Helping Newborns Breathe q Tens of thousands of babies died annually from a mysterious respiratory ailment. q Clinical investigators characterized the patients and studied infant respiratory and human lung physiology. q Basic studies of surface tension and pulmonary physiology allowed researchers to identify and characterize pulmonary surfactant. q Clinical and basic scientists determined that the deaths were due to lack of surfactant, causing alveoli to collapse.. q Treatments were then developed in the lab and tested and applied to patients with great clinical success. 12 Copyright ccrpcourse.com

  13. Combating Breast Cancer q Basic research findings demonstrated the anti-tumor effects of Tamoxifen in lab animals. q Clinical researchers showed that Tamoxifen shrank breast tumors in afflicted women and reduced the risk of tumor recurrence. q Clinical researchers also demonstrated that healthy women treated with Tamoxifen were less likely to develop Breast Cancer. q Tamoxifen is now widely used in Breast Cancer treatment and prevention. 13 Copyright ccrpcourse.com

  14. Who Funds Clinical Research? v Federal Government ▪ National Institute of Health (NIH) ▪ Department of Veteran Affairs (DVA) ▪ Center for Disease Control and Prevention (CDC) ▪ Agency for Health Care Research and Quality ▪ Department of Defense v State and Local Governments v Private Organizations ▪ Foundations and other Not-for-Profits ▪ Industry 14 Copyright ccrpcourse.com

  15. National Institute of Health ➢ NIH Mission : ▪ Science in pursuit of fundamental knowledge about the nature and behavior of living systems ▪ Application of that knowledge to extend healthy life ▪ Reduce the burdens of illness and disability ➢ NIH is the major sponsor of clinical research. ➢ Clinical Research Initiatives : ▪ NIH Roadmap : Reengineering the Clinical Research Enterprise ▪ Clinical and Translational Science Awards 15 Copyright ccrpcourse.com

  16. NIH and Clinical Research 16 Copyright ccrpcourse.com

  17. NIH Spending on Clinical Research 17 Copyright ccrpcourse.com

  18. Clinical Research Enterprise q Improve medical diagnostics and treatment. q Enhance access to and haring of data through integrated clinical research networks. q Enhance clinical outcomes assessment by developing a computerized system to collect and store patient-reported outcomes data. q Expand and diversify clinical research workforce by optimizing training and career development programs. q Harmonize federal requirements regarding conduct of clinical research to facilitate compliance with regulations and policies. q Promote translational research by improving clinical research infrastructure ( Clinical and Translational Science Award Program) 18 Copyright ccrpcourse.com

  19. Clinical Research Enterprise 19 Copyright ccrpcourse.com

  20. Clinical and Translational Science Awards q Transforms academic health centers into definable academic homes for clinical and translational science, which work together to improve the conduct of clinical research. q Subsumes some General Clinical Research Centers (GCRC). q 38 academic health centers currently participating. q Funded from existing Clinical Research Programs and Roadmap Dollars. q No funds are taken from basic research. 20 Copyright ccrpcourse.com

  21. Department of Veterans Affairs q Medical and Prosthetics Research : Core of the VA Research and Development Program. q VA has four major R&D areas : ▪ Clinical Science Research and Development Service ▪ Health Services Research and Development Service ▪ Laboratory Research and Development Service ▪ Rehabilitation Research and Development Service q 75% of supported researches are clinician scientists. q More than half of all VA research is for investigator-initiated projects. q All R&D investment is intramural. 21 Copyright ccrpcourse.com

  22. Other Federal Sponsors of Clinical Research q Agency for Health Care Research and Quality ▪ Clinical practice ▪ Patient safety ▪ Health IT ▪ Population care ▪ Evidence-based medicine q Center for Disease Control and Prevention ▪ Infectious disease ▪ Disability ▪ Environmental health ▪ Health statistics 22 Copyright ccrpcourse.com

  23. Other Federal Sponsors of Clinical Research q Department of Defense ▪Congressional Special Interest Research Programs : Research on • Breast • Prostate • Ovarian cancer • Other diseases ▪ Deployment Health Related Research : • Research on conditions affecting deployed or military (e.g. PTSD) ▪ Defense Advanced Research Projects Agency : • Funding for applied biological research (e.g. exposure) previously deployed effects of bioagent 23 Copyright ccrpcourse.com

  24. Private Sponsors of Clinical Research q Not-for-profits • Foundations, voluntary health organizations, and research institutes. ▪ Bill and Melinda Gates Foundation ▪ Burroughs-Wellcome Foundation ▪ Juvenile Diabetes Research Foundation. q Industry • Pharmaceutical, biotechnology, and medical device firms. ▪ Pharmaceutical Research and Manufacturers of America (PhRMA). ▪ Biotechnology Industry Organization (BIO) §Total R&D spending by industry in 2006 estimated - $56.1 Billion §Total PhRMA spending on R&D in 2006 estimated - $43.4 billion 24 Copyright ccrpcourse.com

  25. How is Clinical Research Regulated? q Office of Human Research Protections • Protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services. q Food and Drug Administration • Regulates the approval process • Assures the safety, efficacy, and security of drugs, biological products, medical devices. q Local Institutional Review Boards • Conducts initial review of research proposals. • Ensures participants are not exposed to unreasonable risks and that they give the informed consent. • Conducts continuing review of approved research to ensure that human-subjects protections remain in force. 25 Copyright ccrpcourse.com

  26. Challenges q Difficulty balancing patient care and research responsibilities. q Expensive medical training q Lower salaries compared to private clinicians. q Long training time compared to medical school peers. q Burdensome regulations and paperwork. q Insufficient mentoring due to competing pressures. q Low success rate for CROs. 26 Copyright ccrpcourse.com

  27. Resources q National Institute of Health q Association of American Medical Colleges q Association for Patient-Oriented Research q Clinical Research Forum q Health Research Alliance 27 Copyright ccrpcourse.com

  28. Copyright 28 ccrpcourse.com

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