dr kamal dhaliwal

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CLINICAL RESEARCH ASSOCIATE ENTRY LEVEL HOW TO BECOME A CLINICAL RESEARCH ASSOCIATE clinical research experience CLINICAL RESEARCH ASSOCIATE CERTIFICATION

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1 An Introduction To Clinical Research Copyright cc rpc ours e .c om Axilogy Consultants LLC

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Copyright ccrpcou rse.com 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.

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Copyright ccrpcou rse.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 Therapeutic interventions. Development of new technologies. Epidemiologic and behavioral studies. Outcomes and health services research.

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Copyright ccrpcou rse.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.

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Copyright ccrpcou rse.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

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Copyright ccrpcou rse.com 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

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Copyright ccrpcou rse.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.

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Copyright ccrpcou rse.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

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Copyright ccrpcou rse.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

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Copyright ccrpcou rse.com 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

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Copyright ccrpcou rse.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.

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Copyright ccrpcou rse.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.

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Copyright ccrpcou rse.com 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

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Copyright ccrpcou rse.com 14 Who Funds Clinical Research v Federal Government ▪ National Institute of Health NIH ▪ Department of Veteran Affairs DV A ▪ 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

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Copyright ccrpcou rse.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

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Copyright ccrpcou rse.com 16 NIH and Clinical Research

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Copyright ccrpcou rse.com 17 NIH Spending on Clinical Research

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Copyright ccrpcou rse.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

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Copyright ccrpcou rse.com 19 Clinical Research Enterprise

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Copyright ccrpcou rse.com 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

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Copyright ccrpcou rse.com 21 q Medical and Prosthetics Research : Core of the VA Research and Development Program. q VA has four major RD 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 RD investment is intramural. Department of Veterans Affairs

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Copyright ccrpcou rse.com 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

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Copyright ccrpcou rse.com Other Federal Sponsors of Clinical Research q Department of Defense ▪Congressional Special Interest Research Programs : Research on • Breast • Prostate • Ovarian cancer previously deployed effects of bioagent 23 • 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

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Copyright ccrpcou rse.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 RD spending by industry in 2006 estimated - 56.1 Billion §Total PhRMA spending on RD in 2006 estimated - 43.4 billion

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Copyright ccrpcou rse.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 ef ficacy 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.

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Copyright ccrpcou rse.com 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

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Copyright ccrpcou rse.com 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

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Copyright ccrpcourse.com 28

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