Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Introduction to Clinical Research - I
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. Phase 1 trials are done to find out :Safe dosage rangeSide effectsHow the body copes with the drugUsually –small trials, recruiting 20-100 healthy volunteers or cancer patients(end stage)Patients are recruited very slowlyFirst few patients are given very small dose. Then the researchers measure how the subjects' health changes.Another way of classifying trials is by their purpose. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). If you continue browsing the site, you agree to the use of cookies on this website. But, you may not have enough time to build it. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. With this in mind, we have produced this research handbook. Give the brief introduction of your work. Confirmatory Phase (Therapeutic confirmatory trial)‏Trials are done to obtain sufficient evidence about efficacy and safetyConducted in larger number of patients.In comparison with standard drug/placebo.To establish efficacy of the drug against existing therapy in larger number of patientsTo establish the safety in relatively large number of patientsTo establish method usage in clinical practicesTo identify contraindications, warningsPhase IIIATo get the therapeutic and safety information about the drug on a lager number and diversified subjects.Generate sufficient and significant data to file NDAPhase IIIBAllows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchasePerforming trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing)To obtain additional safety data, or to support marketing claims for the drug, Phase IVPhase IV trial is also known as Postmarketing surveillance Trial. The dose is subsequently escalated for further groups, up to a predetermined level. The medical PowerPoint templates can help you to create some of the most effective presentation backgrounds for the purpose. Core concepts will be introduced along four key themes: diagnosis, prognosis, treatment and etiology. HEALTH COMMUNICATION & MASS MEDIA IN PUBLIC HEALTH, Science dissemination 2.0: Social media for researchers, Health system research designs and methods, Analysis and statement of the research problem, Public Health 2.0 - PowerPoint Presentation, HEALTHCARE RESEARCH METHODS: Secondary and tertiary Studies. Details. Unusual Growth Conditions/How's a Bug to Survive? In contrast to more traditional … modèle ppt de recherche en laboratoire médical File Size: 229.59KB Temps de téléchargement: 1759 Structure moléculaire chimique, modèle de recherche de laboratoire médical ppt STEPS IN MEDICAL RESEARCH Science is known to be a systematic study that follows a pattern and produces testable results. INTRODUCTION TO Randomized Phase II trials have far fewer patients than randomized Phase III trials. Created by:Benhur Pradeep.Pradeep.ben84@gmail.comKeep visiting “http://www.myclinicalresearchbook.blogspot.com”. See our User Agreement and Privacy Policy. Centre for Reproductive Ethic s and Rights . Citation. “Regulatory authorities” includes the authorities that review submitted clinical data and those that conduct inspections. The 10 Best Free Medical PowerPoint Templates, Keynote Theme, and Google Slides is a list that presents you a set of templates that will be very helpful when giving to your audience. Clinical research involves the processes by which a drug or medical device or treatment or surgery procedure or biologicals are developed and tested for its effectiveness and safety and at the same time ensuring the complete safety of volunteers participating in the research studies. It might be an opportunity for you to pitch yourself in getting hired as a medical professional in a new company. We have collaborated with solid information and great involvement in Site Management of Clinical Research. (ICH) According to 21 CFR 50.3, a corporation or agency whose employees conduct the investigation is considered a sponsor and the employees are considered investigators.CRO: (Contract Research Organization/Clinical Research Organization)An organization to which the sponsor may transfer or delegate some or all of the tasks ,duties and or obligations regarding a clinical study.Clinical research associate (CRA):Person employed by a sponsor, or by a contract research organization acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a clinical study. INTRODUCTION TO CLINICAL RESEARCH FOR RESIDENTS Read Evaluate Study Experiment Apply Revise Circumstantiate Harness 2014 The Saudi Commission for Health Specialties The Department of Medical Education & Postgraduate Studies . Either way, you need a medical PPT presentation that showcases what you've got to offer. Introduction to medical research: Essential skills Iveta Simera EQUATOR Network, Centre for Statistics in Medicine, NDORMS EQUATOR –OUCAGS training course 13 September 2014 . Show: Recommended. Medical researchers will lean how to translate real clinical problems into tangible research questions for investigation, gaining insight into some of the most important considerations when designing an epidemiological study along the way. All Diagrams; Cycle Diagrams; Relationship Diagrams; Agenda & Org Diagrams; Flow & Process Diagrams; Stair & Step Diagrams; Timeline Diagrams ; PPT Charts & etc. What is required today is applied research – research that impacts the health of the individual and the community, resulting in meaningful improvement in health status. MAD Multiple Ascending Dose studies are conducted to better understand the pharmacokinetics & pharmacodynamics of multiple doses of the drug. For example, if you are going to work on a disease than describe the. These studies are closely monitored and regulated to determine that all the data collected is done in a methodical way and is accurate. Such tests assist pharmaceutical companies to decide whether a drug candidate has scientific merit for further development as an investigational new drug. This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the Maximum tolerated dose (MTD)). The Purpose and Process of Health Research 3. Clipping is a handy way to collect important slides you want to go back to later. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. Sections; Download Chapter PDF; Share. At the end of this unit, you will be competent in a range of basic laboratory techniques, using a variety of instruments and have a grounding in the theoretical principles on which these techniques are based. Regulator/Regulatory Body/Regulatory Authority:Bodies having the power to regulate. Maybe your presentation will showcase new medical research that you've been working on. Our assumptions are that you will schedule appropriate planning and preparation time, are interested in doing the best job possible, and know that a quality presentation is a combination of good research and communication skills. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.Screening trials: test the best way to detect certain diseases or health conditions.Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition.Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.Quality of life trials: explore ways to improve comfort and the quality of life for individuals with a chronic illness (a.k.a. disease. For all types of trials, the participant works with a research team. 14. Medical Ethics in the ‘Global Village’ Ray Noble . health – the 10/90 gap in medical research (only 10% of global research funding is spent on health problems that affect 90% of the world’s population). One way of classifying clinical trials is by the way the researchers behave.In an observational study, the investigators observe the subjects and measure their outcomes. Or perhaps a news headline makes reference to a groundbreaking piece of medical research into a pos-sible cure for HIV/AIDS. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Introduction To Research PowerPoint PPT Presentations. INTRODUCTION TO HEALTHCARE RESEARCH METHODS 1. THE NATIONAL HOSPITAL FOR NEUROLOGY AND NEUROSURGERY DEVELOPMENT FOUNDATION, Attended Nishtar medical university multan. Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator, research nurse, protocol nurse.Institutional review board (IRB):An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.Subject/trial subject:An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control. (US FDA)Also known as human micro dosing studies and are designed to speed up the development of promising drugs.Gathers preliminary data on Pharmacodynamics (what the drug does to the body) and Pharmacokinetics (what the body does to the drug).Gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to acquire information on how the drug is processed within the body. Medical PPT; Nature PPT; Finance PPT; Food PPT; Real Estate PPT; Religion PPT; Industry PPT; Sports PPT; Recreation PPT; Military & Weapon PPT; Travel & Culture PPT; PPT Diagrams. UCL Institute for Women’s Health. Tools used in research design ; Research Design Plan and structure of the investigation so as to answer the research Now customize the name of a clipboard to store your clips. Introduction to Research Methodology D.A. Twitter: @khaled_ouanes Participants in an interventional (treatment) clinical trial are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Asir John Samuel, BSc (Psy), MPT (Neuro Paed), MAc, DYScEd, C/BLS, FAGE All Time. The clinical trial process depends on the kind of trial being conducted. Introduction to Statistics. Introduction Research is one of those words that you are likely to come across on an almost daily basis. Recent designation for exploratory, first-in-human trials. Professor of Radiodiagnosis, Faculty Member CERTC, ... A Sociologist studying villagers about their feelings towards ... – A free PowerPoint PPT presentation (displayed as a Flash slide show) on PowerShow.com - id: 1bc6db-ZDc1Z Introduction This unit equips you with introductory level clinical laboratory skills and theoretical knowledge in the disciplines of Haematology, Clinical Chemistry and Microbiology. 1. The researchers do not actively manage the study.In an interventional study, the investigators give the research subjects a particular medicine or other intervention. Introduction to Research: 2. Health research is the process of scientifically investigating a particular well-defined aspect of physical, mental, or social well-being of individuals. Academia.edu is a platform for academics to share research papers. Clinical trial participation is most successful when the protocol is carefully followed, including frequent contact with the research staff. Looks like you’ve clipped this slide to already. 49+ FREE PRESENTATION Templates - Download Now Microsoft Word (DOC), Adobe Photoshop (PSD), Google Docs, Microsoft PowerPoint (PPT), Apple (MAC) Pages, Adobe Illustrator (AI), Apple (MAC) Keynote, Google Slides Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Research Paper Presentation Outline Introduction. 7 Section Overview 7 Section Learning Outcomes 7 1.1 Research defined 7 1.2 Research as a process 8 1.3 Generalised summary of the research process 12 1.4 What makes research … The drug-development process will normally proceed through all four phases over many years. To get the best results, download this immediately! … Academia.edu is a platform for academics to share research papers. Medicine is… Hippocrattes Rod (Staff) of Asclepius . Each phase of the drug approval process is treated as a separate clinical trial. Phase IV are 'post-approval' studies.Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.Pre-clinical studiesIt involves in vitro (test tube or cell culture) and in vivo (animal) experiments using wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses. The clinical trial team includes doctors and nurses as well other health care professionals. See our Privacy Policy and User Agreement for details. Introduction to Medical Ethics . Introduction to Research 1. mation in the medical research paper using Swales' (1981, 1990) genre- analysis model. The protocol is a study plan on which all clinical trials are based. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. These studies are usually run as a crossover study, with volunteers being given two identical doses of the drug while fasted, and after being fed. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. Introduction to Research Methods Supercourse Formulating Research Problems, Questions and Hypotheses Introduction to the course and to your assignment This project is made possible by the support of the American people through the United States Agency for International Development (USAID). Microbial Cell Ultrastructure and Function. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Unit One: Introduction to Research Unit Information 3 Unit Overview 3 Unit Aims 3 Unit Learning Outcomes 3 Key Reading 4 Further Readings 4 References 5 Weblinks and Portals 6 Multimedia 6 1.0 What is research? introduction • e santé , cyber ... medical informatics, public health and business, referring to health services and information delivered or enhanced through Pour plus de modèles : Modèles Powerpoint PPT gratuits Page 5 the Internet and related technologies.” • Journal of Medical Internet Research defines eHealth. Please consult the latest official manual style if you have any questions regarding the format accuracy. Characteristics of the Scientific Method Characteristics of Scientific Knowledge General Approaches to Research Types of Research in Public Administration 3. Anabolism. Medical College,Bhopal, L.N.C.T. RESEARCHJOFRED M. MARTINEZ, RN, MAN • ST. ANTHONY’S COLLEGE INTRODUCTION TO NURSING 2. This and subsequent articles will focus on planning, preparation, creating visual aids (slides), and presentation skills for a scientific presentation. PHC215 Introduction to Medicine Department of Medical Humanities School of Medicine University of Split . Basic Microbial Metabolism. February 21, 2006; 2 Statistics and Research Design. Nursing Research 1. Academia.edu is a platform for academics to share research papers. Exchange of Genetic Material. Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Medical College and J K hospital Bhopal. Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. These bodies are sometimes referred to as competent authorities. 1. You can change your ad preferences anytime. By Dr. Khaled Ouanes Ph.D. Other Phase II trials are designed as randomized clinical trials, where some patients receive the drug/device and others receive placebo/standard treatment. E-mail: k.ouanes@seu.edu.sa Standard Growth Conditions and Measurement of Growth. • Research is an organized inquiry carried out to provide information for solving problems. ♦ To gain familiarity or achieve a new insight towards a certain topic.♦ To verify and test important facts♦ To analyze an event, process or phenomenon♦ To identify the cause and effect relationship♦ To find solutions to scientific, non-scientific and social problems♦ To determine the frequency at which something occurs What makes people do research?♦ Desire to get a research degree♦ Desire to solve unsolved and challenging problems♦ De… Dr. Harikumaran Nair.G.S. Usually, they compare the treated subjects to subjects who receive no treatment or standard treatment. London . A phase 1 trial is the first step in testing a new agent (drug or compound) in humans.Clinical trials involving new drugs are commonly classified into four phases. File Format. 1.introduction to research methodology 1. If they do not exhibit any adverse side effects, and the pharmacokinetic data is roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given a higher dose. Medical Research Proposal Format in DOC . DOC; Size: 41 KB. PHC215 By Dr. Khaled Ouanes Ph.D. E-mail: k.ouanes@seu.edu.sa Twitter: @khaled_ouanes INTRODUCTION TO HEALTHCARE RESEARCH METHODS 2. Introduction to Research: General Concepts What is research? Although based on Swales' model, this study represents an application of the model beyond Swales' article introduction to the whole body of the research article. If you continue browsing the site, you agree to the use of cookies on this website. MEDICAL RESEARCH. FOMAT Medical Research … Thus scientific research must follow a step-by-step pathway that foster clarity and avoids the problem of multiplicity. Medical Research Clinical Medicine Diagramme médical PPT File Size: 269.22KB Temps de téléchargement: 388 research.ntu.edu.sg. Microbial Metabolism--Mechanisms for Procuring Energy. HEALTHCARE RESEARCH HEALTHCARE RESEARCH METHODS: Primary Studies: Developing a Questionnaire - Su... No public clipboards found for this slide, INTRODUCTION TO HEALTHCARE RESEARCH METHODS, Associate Professor in Pharmacology at L.N.C.T. All Charts & etc; Charts Diagrams; … Chapter ! You may have read in the newspaper that the latest market research study links passive smoking to an increased likelihood of lung cancer. As our Medical Research Proposal Submission Form has been designed in DOC format to give you the unique experience of writing your proposals with the factual information and numeric data to make your project more appealing. Email; Twitter; Facebook; Linkedin; Reddit; Get Citation. Introduction to Medical Research. USEFUL MEDICAL WEBSITES ... Introduction to Microbiology. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. PERT/Neuro- Critical care Outreach,Senior staff nurse, The National Hospital for Neurology and Neurosurgery UCLH London. Download. INTRODUCTION TO COMMUNITY-BASED PARTICIPATORY RESEARCH In the six years since the fi rst edition of this book went to press, community-based partici-patory research (CBPR) has achieved growing attention as a collaborative approach to research that offers new hope for studying and addressing some of our most intractable health and social problems. Immunology: All you wanted to know but were afraid to ask. 4. If all goes well, then the next group will be given a higher dose and so on… until… the best dose if found out. Presenting your medical research, pharmaceutical products, and your data do not have to be challenging as it used to be. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.Phase II studies are sometimes divided into Phase IIA and Phase IIB.Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).Some trials combine Phase I and Phase II, and test both efficacy and toxicity.Trial design Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. A protocol describes what types of people may participate in the trial; the length of the study; and if applicable, the schedule of tests, procedures, medications, and dosages. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood Universal Declaration of Human Rights . The more people that participate in clinical trials, the faster we can answer the critical research questions that will lead us to better treatment and prevention options for a range of diseases. Sort by: Introduction to Research ... Introduction To FOMAT Medical Research - FOMAT Medical Research is the biggest site administration association (SMO) in Oxnard, California. At some sites (primarily in academic settings), clinical research coordinators are called CRAs ormonitor.Investigator/Sub-Investigator:Investigator A person responsible for the conduct of the clinical trial at a trial site. This is called DOSE ESCALATING STUDY.This phase includes trials designed to access thesaftey tolerability pharmacokineticspharmacodynamics of drughere are different kinds of Phase I trial:SAD Single Ascending Dose studies are those in which small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time. Food effect A short trial designed to investigate any differences in absorption of the drug by the body, caused by eating before the drug is given. All human beings are born free and equal in dignity and rights. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.Sub-Investigator Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).Clinical research coordinator (CRC):Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor’s visit. Clinical research involves the processes by which a drug or medical device or treatment or surgery procedure or biologicals are developed and tested for its effectiveness and safety and at the same time ensuring the complete safety of volunteers participating in the research studies. Health research is the process of scientifically investigating a particular well-defined aspect of physical, mental, or social well- being of individuals. Statistics Theory and method of analyzing quantitative data from samples of observations to help make decisions about hypothesized relations. Usually, this involves a disease for which no effective therapy exists, or a patient that has already attempted and failed all other standard treatments and whose health is so poor that he does not qualify for participation in randomized clinical trials. : Introduction to Clinical Research is a part of the YouTube series "Clinical Researcher" by Dr. Sulaiman Sait. METHODS. Clinical trials take place in phases.Once laboratory studies (in test tubes and animals) show that a new approach has promise, a phase 1 trial can begin. Supportive Care trials).Compassionate use trials or expanded access: provide partially tested, unapproved therapeutics prior to a small number of patients that have no other realistic options. Whereas, there are other types of research trials that involve interviews, questionnaires, or surveys instead of interventional treatment. Disclaimer: These citations have been automatically generated based on the information we have and it may not be 100% accurate. Focus on the things on which you have worked on. ) genre- analysis model trials involve more tests and doctor visits than the participant would have... Should act towards one another in a new company, 2006 ; 2 Statistics research... The YouTube series `` clinical Researcher '' by Dr. Khaled Ouanes Ph.D.:... And conscience and should act towards one another in a spirit of brotherhood Declaration! After it receives permission to be challenging as it used to be challenging as it to. Have enough time to build it not have enough time to build it pos-sible for. Any questions regarding the format accuracy have produced this research handbook aspect of physical, mental, or restricted certain... Of Multiple doses of the participants as well other health care professionals those that conduct inspections the is! Linkedin profile and activity data to personalize ads and to provide you with relevant.. You need a medical PPT presentation that showcases What you 've got to.., including frequent contact with the research subjects a particular medicine or other.... Level clinical laboratory skills and theoretical Knowledge in the disciplines of Haematology, clinical Chemistry and Microbiology Approaches. New medical research that you are going to work on a disease than describe.! The disciplines of Haematology, clinical Chemistry and Microbiology, MAN • ST. ANTHONY ’ S INTRODUCTION!, if you have any questions regarding the format accuracy Pradeep.Pradeep.ben84 @ gmail.comKeep visiting http! Useful medical WEBSITES... INTRODUCTION to clinical research is the process of scientifically a! ) and ongoing technical support of a clipboard to store your clips pharmaceutical companies to whether! Of scientifically investigating a particular well-defined aspect of physical, mental, social! For HIV/AIDS ) genre- analysis model research Design born free and equal in dignity and rights follow a pathway. Clinical trials involve more tests and doctor visits than the participant would normally for! Particular medicine or other intervention to be to go back to later trial process depends on the we. These studies are closely monitored and regulated to determine that all the data collected is done in spirit... 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To know but were afraid to ask standard treatment Outreach, Senior staff,!, the participant works with a research team the medical research that you are going to work on disease. Has Scientific merit for further development as an investigational new drug clinical Chemistry and Microbiology many years ads. Human rights and others receive placebo/standard treatment is a study plan on which you worked... Of Asclepius format accuracy to help make decisions about hypothesized relations ; health changes.Another way of trials. & amp ; pharmacodynamics of Multiple doses of the Scientific Method characteristics of the Scientific Method characteristics Scientific. Generated based on the kind of trial being conducted particular introduction to medical research ppt or other.. And Microbiology Benhur Pradeep.Pradeep.ben84 @ gmail.comKeep visiting “ http: //www.myclinicalresearchbook.blogspot.com ” foster clarity and avoids the problem of.. 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