Training Contents

Overview of Clinical Study Design
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration).It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness (Wikipedia).
research, question, design, study design, observational, experimental, intervention-based spectrum, ideal study design, randomized and non-randomized, parallel group design, sequential trials, crossover study, factorial design, adaptive design, enriched enrollment designs, group, cluster randomized studies, intent to treat, comparison groups,

Design of Epidemiologic Studies
Epidemiology is the method used to find the causes of health outcomes and diseases in populations. In epidemiology, the patient is the community and individuals are viewed collectively. By definition, epidemiology is the study (scientific, systematic, and data-driven) of the distribution (frequency, pattern) and determinants (causes, risk factors) of health-related states and events (not just diseases) in specified populations (neighborhood, school, city, state, country, global). It is also the application of this study to the control of health problems (Source: Principles of Epidemiology, 3rd Edition).
epidemiology, variables, confounding, causal inference, experimental, observational, case reports, series, descriptive statistics, cross-sectional, prevalence, incidence, cohort, prospective, longitudinal, nested, bias

A New Era of Research: Practicing Interdisciplinarity
The idea of interdisciplinary research is that each individual on a team will apply their discipline alongside others’ disciplines to answer research questions. Interdisciplinary research is the way of the future. But, as science has advanced over the past decade, two fundamental themes are apparent: the study of human biology and behavior is a wonderfully dynamic process, and the traditional divisions within health research may in some instances impede the pace of scientific discovery (NIH). Working with others is the surest way to ensure our research completes the spectrum from bench-to-bedside-to bench.
interdisciplinary research, individual, team, discipline, research questions, dynamic, bench-to-bedside-to-bench, pareto principle,
University of Wisconsin-Madison School of Medicine and Public Health

Why Comparative Effectiveness Research Matters
Comparative Effectiveness Research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition, or to improve the delivery of care. The goal of CER is to provide stakeholders (patients, caregivers, providers, payers, policy makers) with information that can be used to make decisions about the benefits/tradeoffs between two or more tests, treatments/interventions, care delivery systems, or policies. As such, stakeholder engagement is often a part of the research process and the outcomes of CER should be relevant to these stakeholders. Dissemination of findings in a manner that is useful for stakeholders is also an important aspect of CER.
CER, comparativ effectiveness research, clinical, benefits, harms, decisions,
Tufts Clinical and Translational Science Institute

An Introduction to Pragmatic Clinical Trials
One of the most interesting developments we have in the arena of clinical trials is the development of the pragmatic clinical trial. In comparison to typical clinical trials, pragmatic clinical trials seek to answer what treatments are effective in the “real world” sense of medicine. To this end, pragmatic clinical trials are substantially more inclusive in terms of enrollment by relaxing restrictions on comorbidities. Enrollment itself often occurs where patients are being treated, such as a hospital or clinic rather than a special-use laboratory. As a result, researchers are able to collect data that is likely to be replicated successfully across diverse demographics.
clinical trials, pragmatic, typical, real world, inclusive, enrollment, diversity, diverse enrollment, comorbitities,
Alberta Strategy for Patient Oriented Research (SPOR)

Clinical Research Methods
The purpose of this course is to examine innovative treatments, such as stem cell research for replenishment of lost cell function, RNA interference in harmful pathways, and genetic engineering to replace lost gene product functioning. As exciting as these treatments are in terms of development, there exists a great deal of controversy surrounding them. Therefore, we must understand the methodology used in developing these therapies to alleviate resistance to the use of new technologies due to misunderstanding of the techniques and their potential side effects. To do this, we’ll use reviews and primary literature.
clinical research, methods, treatments, stem cell research, rna interference, genetic engineering, methodology, technology
Professional Development Core

Strength in Writing: Writing for Publication
As you perform your research studies, you’ll come to realize that your research is telling a story that contributes to the human knowledge base. Dr. Brian Waters, an associate professor from the University of Nebraska-Lincoln will walk you through the steps of publication which includes common reasons for rejection and publication, selecting the right journal for your publication, the writing process, and addressing reviewer feedback.
writing, publication, peer review, rejection, response, editing, journal, feedback
Brian Waters, PhD (University of Nebraska-Lincoln)

Formulating Research Questions, Hypotheses, and Objectives
In this module, we’ll be learning about developing research questions, research design, and collaboration. These are all elements that combine to form the basis for interdisciplinary research, which is what DaCCoTA is all about. Without learning to work together in well-thought-out, systematic research, the goals of gaining knowledge will seem beyond our grasp. We’ll also take a look at available statistical software in addition to examining scientific literature.
research questions, hypothesis, hypotheses, objectives, design, collaboration, interdisciplinary, literature, software,
Tufts Clinical and Translational Science Institute

Strategies for Developing a Team Science Grant Proposal
In interdisciplinary science, you’re only as strong as your team. With the right team, you’ll be able to realize your goals as a primary investigator. With the wrong team, your research project will quickly descend into dysfunction. We’ll hear from Amy Gantt, director of the Office of Research Development at Tufts University. In this module, she’ll recount principles of good team science and anecdotes of success and failures.
team science, grant, proposal, writing, timeline, planning, strategy,
Tufts Clinical and Translational Science Institute

Introduction to Predatory Publishing
In academic and research careers, we’re often under immense pressure to publish our findings as quickly as possible so that we may advance scientific dialogue and our presence within that dialogue. However, not all journals have our best interests at heart, and the consequences of publishing with these journals can cost you opportunities, promotion, and your reputation. We call these journals “predatory journals” because they prey on researchers and academics for profit. Ruth Bueter, a Serials and Systems Librarian for The George Washington University’s Himmelfarb Health Sciences Library in Washington, D.C. will walk us through how to identify predatory publications to help you preserve scientific progress.
predatory, publication, peer-reviewed, profit, writing,
George Washington University’s Himmelfarb Health Sciences Library

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