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Arts Samantha Brambilla

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Basic Science Methods For Clinical Researchers



Basic Science Methods for Clinical Researchers addresses the specific challenges faced by clinicians without a conventional science background. The aim of the book is to introduce the reader to core experimental methods commonly used to answer questions in basic science research and to outline their relative strengths and limitations in generating conclusive data.




Basic Science Methods for Clinical Researchers



The ASCO/AACR Methods in Clinical Cancer Research Workshop is an intensive workshop in the essentials of effective clinical trial designs of therapeutic interventions in the treatment of cancer for clinical fellow and junior faculty clinical researchers in all oncology subspecialties, including radiation, surgical oncology, and radiology.


The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more.


This is Part One of a two-part biostatistics training sequence. This course serves as an introduction to the principles and methodologies of biostatistics for clinical researchers. The material covered includes probability and distribution, descriptive statistics, point and interval estimation, hypothesis testing, correlation, linear regression, ANOVA, ANCOVA, logistical regression, survival analysis, and non-parametric tests.


The aims of this course are to introduce trainees to basic epidemiologic concepts, methods and topics, and to provide them with skills to critically evaluate published literature, interpret data, and develop and evidence based approach to medical practice. Upon completion, trainees will be able to apply basic epidemiologic principles and methods to problems encountered in clinical medicine.Co-requisite: MCR 506Offered


This monthly lunchtime seminar is designed to expose clinical and basic science students to contemporary topics in clinical and translational research. Topics include. "-Omics", Biobanking and Biorepositories, Biomedical Informatics, Imaging and Big Data. Lunch will be provided.


This course aims to introduce trainees to the different aspects of clinical trial design, conduct, management and analysis; and to provide trainees with a basic understanding of the key elements of clinical trial design and practice..2 credits, Fall term, Professor Leslie Hyman, PhD


This course provides an overview of research methods as applied to questions raised in the fields of population health and clinical science. It covers the topics of risk adjustment, cost assessment, access to, utilization and quality of care, outcomes and health status measurement, and health system performance.


The dual M.D./MCTR Degree Program aims to produce clinical researchers skilled in conducting patient or population-based clinical studies or outcomes research. In one year of full-time study during their fourth year at UConn (after the first three years of medical school), students will earn enough credits to complete the program and be on their way to becoming physician investigators.


The certificate program focuses on the preparation of individuals with established, terminal degrees in a health related field (M.D., Ph.D., Pharm.D., D.D.S., or D.M.D.) or enrolled and in good standing in such a terminal degree program. The purpose of the certificate program is to familiarize the student with the approaches and methods of clinical and translational research so that they may better serve the community as researchers, teachers, public health administrators, clinicians, and industry employees competent to carry out the broad health mission of the State of Connecticut. The certificate program is intended for those persons who are unlikely to develop independent research but would benefit from an understanding of how such research is conducted.


The certificate in clinical and translation research is conferred when the 3 core courses (2 in clinical research methods and 1 in basic or intermediate biostatistics) are satisfactorily completed. The certificate will be granted by The Graduate School.


Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide:


Instead, Phase 2 studies provide researchers with additional safety data. Researchers use these data to refine research questions, develop research methods, and design new Phase 3 research protocols.


Understanding the basic principles involved in designing and conducting clinical and translational research is an essential component of modern medical education. The Clinical and Translational Research (CTR) Track provides medical students with an exciting and stimulating immersion into research that spans the entire range of medical disciplines.


All students will receive an instruction in basic principles of clinical and translational research, including hypothesis generation and testing, protocol development, clinical research methods and techniques, data analysis and synthesis, scientific manuscript writing and publication methods, and responsible conduct of research. This instruction will come in the form of online training and classroom lectures.


The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible to secure that knowledge. The path to finding out if a new drug or treatment is safe or effective, for example, is to test it on patient volunteers. But by placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science.


A study should be designed in a way that will get an understandable answer to the valuable research question. This includes considering whether the question researchers are asking is answerable, whether the research methods are valid and feasible, and whether the study is designed with a clear scientific objective and using accepted principles, methods, and reliable practices. It is also important that statistical plans be of sufficient power to definitively test the objective, for example, and for data analysis. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose


For research to be ethical, most agree that individuals should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.


Preclinical research connects the basic science of disease with human medicine. During this stage, scientists develop model interventions to further understand the basis of a disease or disorder and find ways to treat it. Testing is carried out using cell or animal models of disease; samples of human or animal tissues; or computer-assisted simulations of drug, device or diagnostic interactions within living systems.


'If clinicians are recruited to participate in research activities and their participation is seen as valuable, as opposed to just being a passive partner for a study, then they'll come to the table to help with the conceptualization and contribute to the science and all of the project.' Quote from a clinician involved with research in community clinical practices settings.


Translational research - i.e., research aimed at optimizing the ways in which biomedical and clinical research are linked with clinical practice and diffusion to community settings - provides an unprecedented opportunity for practicing clinicians to improve the health of Americans. Engagement of clinicians in the research enterprise will allow the extraordinary results of the basic, explanatory research conducted in recent decades to be translated into practical applications for responding to the challenges associated with major public health risks, different healthcare delivery organizations, and different types of clinicians. Clinician involvement addresses the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in human subjects, as well as research aimed at enhancing the adoption of best practices in the community.


Ultimately, researchers from all backgrounds can benefit from being trained in all of these, and many more, areas, which will allow them to connect research efforts to the very real needs that exist in clinical settings.


Observational studies monitor people in normal settings. Researchers gather information from people and compare changes over time. For example, researchers may ask a group of older adults about their exercise habits and provide monthly memory tests for a year to learn how physical activity is associated with cognitive health. Observational studies do not test a medical intervention, such as a drug or device, but may help identify new treatments or prevention strategies to test in clinical trials.


Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. These trials are the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device (for example, a pacemaker), is safe and effective in people. Often, a clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments. 041b061a72


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