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Published on : Jul 20, 2021 | Views : 1695 | Downloads : 0

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Slide 1-

Basics of Clinical Research Beth Elinoff, RN, MPH, CCRC Human Immunology Research Coordinator
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What is Clinical Research/Human Subject Research? Department of Health and Human Services (DHHS) Definitions (45 CFR 46.102): 1. Human Subject Research In order for activities to be deemed “Human Subject Research” by the DHHS, they must meet the definition of “research” and involve one or more “human subjects” as defined by DHHS regulations.
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DHHS Definitions (con’t) A. Research “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Belmont Report Definition of Research “Any activity designed to test a hypothesis, permit conclusions to be drawn and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).”
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DHHS Definitions (con’t) B. Human Subjects: “A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.”
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DHHS Definitions (con’t) Intervention: Includes both the physical procedures by which data are gathered (eg. blood draw) and manipulations of the subject or the subject’s environment that are performed for research purposes Interaction: Includes communication or interpersonal contact (eg. questionnaires, interviews) between the investigator and subject
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DHHS Definitions (con’t) Private Information: Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (eg. medical record). Private information must be individually identifiable (eg. the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
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Food and Drug Administration (FDA) Definition of Human Subject Research FDA has different definitions of “research” and “human subjects” FDA guidelines must be followed when using a drug or device in the study
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History of Development of Human Research Protections Public Health Service Syphilis Study ’32-’71 Better known as the “Tuskeegee Syphilis Study” Originally designed to make treatment available to African-American men with syphilis, even though there was no known effective treatment Issues: Men were recruited without their consent Misinformation about procedures, ie spinal taps After penicillin was proven an effective treatment ’40’s), men were denied antibiotics and prevented treatment from military and local physicians
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History of Development of Human Research Protections US Food, Drug and Safety Act (1938) 107 people died after taking sulfanilamide, a cold remedy that contained anti-freeze. This act enforces manufacturers to demonstrate drug safety.
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History of Development of Human Research Protections Nuremberg Code (1947) Result of the trial of Nazi doctors and scientists from WWII – no guidelines for human research Guidelines: Need for informed consent Research should be based on prior animal work Risks should be justified by anticipated benefits Only qualified scientists must conduct research Physical and mental suffering must be avoided No research where death/severe injury is expected
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History of Development of Human Research Protections Nuremberg Code (con’t) Problems: Little impact on research done in the US – thought to condemn Nazis No strength of the law behind it Only applied to non-therapeutic human subject research
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History of Development of Human Research Protections Declaration of Helsinki (1964) Code of ethics developed by the World Medical Association (now known and World Health Org) Broader than Nuremberg Code Geared towards therapeutic medical research Recommended informed consent Precursor to IRB requirement Journals required all published research to follow Declaration’s guidelines
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History of Development of Human Research Protections The National Research Act (1974) Culmination of hearings by US Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Purpose of The National Commission: Identify basic ethical principles underlying the conduct of human subject research Develop guidelines to ensure conduct of human subject research in accordance with those principles
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History of Development of Human Research Protections The National Research Act (con’t) 45 CFR 46 – “Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research”; Issued by the Department of Health, Education and Welfare (later renamed DHHS) Revisions made in late 1970’s and early 1980’s By 1991, 16 other federal agencies/departments applied 45 CFR 46 to research they fund/conduct Referred to as the “Common Rule”
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History of Development of Human Research Protections The Belmont Report (1979) Issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Purpose: resolve ethical problems that surround the conduct of human subject research One principle does not outweigh another; each has equal weight
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History of Development of Human Research Protections The Belmont Report (con’t) The three principles: Respect for Persons – treat people as autonomous creatures and not a means to an end; provide extra protection for those with limited autonomy Requires informed consent Requires respect of privacy of research subjects
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History of Development of Human Research Protections The Belmont Report (con’t) The three principles: Beneficence – minimize harm and maximize benefit Requires use of the best possible research design to maximize benefit and minimize harm Requires researchers to be able to perform the procedures and manage the risks Prohibits research without a favorable risk-benefit ratio
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History of Development of Human Research Protections The Belmont Report (con’t) The three principles: Justice – treat all people fairly and ensure burdens and benefits are shared equitably Requires equitable selection of research subjects Requires avoidance of exploitation of vulnerable populations or populations of convenience (ie pregnant women; children; incarcerated populations)
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History of Development of Human Research Protections International Conference on Harmonisation - ICH (1990) Joint regulatory/industry project to improve process of developing new products between Japan, Europe and United States Allows for international research studies to follow same rules/regulations Conference convenes to update regulations Established “Good Clinical Practices”
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Good Clinical Practices Known as GCP’s Misnomer – they are rules/regulations for the conduct of research Sometimes called “Good Research Practices” Standard for the design, conduct, performance, monitoring, analyses and reporting of research Even though established for drug studies, they dictate appropriate conduct for all research
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Innovative Practice vs. Research Innovative clinical practice is an intervention designed solely to enhance the well-being of an individual patient or client. The purpose is to provide diagnosis, preventative treatment, or therapy to particular individuals. Considered “research” only if previous criteria is met. At UPMC, the introduction of innovative procedures or therapies into clinical practice (when research is not involved), requires review by department chair and the UPMC Technology Assessment Committee/Innovative Practices Sub-Committee prior to implementation.
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Quality Assurance vs. Research Precise definitions to permit the distinction between research studies and quality assurance projects are difficult and have not been established. In general, a quality assurance project is a project that is focused primarily on improving patient care within a given patient care environment and, as such, the outcome may not be generalizable to other patient care environments. Both UPMC and CHP require the submission of all quality assurance projects for review.
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Questions to distinguish QA from Research(any yes response indicates research) Is there a commitment, in advance of data collection, to a corrective plan given any one of a number of study outcomes? Does the PI of the study have both clinical supervisory responsibility and the authority to impose change? Is the research being sponsored/funded by an external agency? Does the proposed study involve the prospective assignment of patients to different procedures or therapies based on a predetermined plan? Does the proposed study involve a “control group” in whom the therapeutic or study intervention is intentionally withheld to allow an assessment of its efficacy?
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Questions to distinguish QA from Research Will the study intervention be delivered in a blinded fashion wherein neither the physician nor the patient knows to whom the study intervention or comparative intervention (eg. standard care, placebo) was given? Is the assessment of outcome blinded to the study intervention for purpose of establishing the efficacy of the intervention? Does the proposed study involve the prospective evaluation of a drug, biologic or device that is not currently approved for general use by the FDA? Will patients involved in the proposed study be exposed to additional risks or burdens beyond standard clinical practice in order to make the results of the study generalizable?
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Types of Study Designs Observational Designs
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Types of Observational Studies Cohort Studies A group of subjects followed over time Purpose: defining the incidence and investigating potential causes of a condition (incidence) Can be prospective – investigator chooses a sample group and measures characteristics in each subject over a period of time that might predict outcomes Can be retrospective – same as prospective, except all data collection and follow-up has happened in the past; only possible if adequate data is available
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Types of Observational Studies Cross-Sectional Studies Similar to cohort studies except all the measurements are made at one time point with no follow-up Purpose: describing variables and their distribution patterns (prevalence) Strength – fast and inexpensive since there is no follow-up or waiting time for outcome
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Types of Observational Studies Case-Control Studies Two groups of people examined for the same outcome Group 1 – “cases” or a population of people with a certain disease Group 2 – “controls” or a population of people without that same disease Purpose: compare prevalence of risk factor(s) in subjects with the disease (cases) versus subjects without the disease (controls)
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Types of Study Designs Observational Designs Experimental Designs – interventional studies
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Experimental Studies These studies evaluate the effects of an intervention Types of interventions: Behavior modification (eg. a walking program to improve weight loss) Drug (eg. a new investigational drug or studying a drug for off-label use – subject to FDA regulations) Device (eg. a new investigational stent – subject to FDA regulations) Strength: Can demonstrate causality
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Phases of Experimental Studies Phase I: Unblinded studies of a small number of healthy volunteers to test safety of treatment (can sometimes use people with the disease) Phase II: Randomized studies of relatively small number of people with the disease to test dose ranges and/or efficacy of treatment
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Phases of Experimental Studies Phase III: Randomized studies of large number of people with the disease to test efficacy of treatment on pre-selected outcomes Phase IV: Large experimental studies or observational studies conducted after treatment has been approved by the FDA to assess performance of treatment (called Post-Market Studies)
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Do I really want to conduct clinical research?
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What Help is Available? University of Pittsburgh IRB/RCCO IRB Coordinators – wealth of knowledge; will perform an informal review prior to official review www.irb.pitt.edu – IRB manual; required forms; link to research training website; etc. Sponsored educational activities – monthly “Ask the IRB” sessions; conferences on current issues; etc. Human Immunology Research Office
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Human Immunology Research Office Assistance with investigational human studies involving transplantation that are initiated by STI research or involves substantial support from STI research Act as repository for all documents related to above studies and all other studies requiring STI research participation (eg. Processing of blood samples on 15th floor BST
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Human Immunology Research Office Services Available: Consultation regarding clinical aspects/logistics of new projects IRB summary protocol and consent form preparation assistance Project coordination: Assist with recruitment based on project Ensure proper handling of samples/specimens from patient to lab
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Human Immunology Research Office Information to be stored in this office: Copies of all current and future IRB submissions Correspondence between IRB and investigators including approval letters, audit reports, etc Correspondence between sponsor and investigators regarding protocol issues RPF training certificates Copies of current CV’s Copies of current licenses
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Human Immunology Research Office To request assistance: Contact office to set up meeting to discuss project, assistance requested, etc Complete research outline (template will be supplied by the office) Contact information: Location: E1540 BST Phone: 412-624-6611 Email: elinoffbd@upmc.edu
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Requirements Prior to IRB Submission Possible UPMC fiscal approval STI PRC (protocol review committee) approval Any protocol submitted to the IRB requires prior scientific review; PRC review includes scientific review. submission is reviewed both by an investigator and a research coordinator Facilitator of committee is Agnes Zachoszcz (all submissions are emailed to her)