scholarly journals Delineando a pesquisa clínica

2019 ◽  
Vol 13 (1) ◽  
pp. 288
Author(s):  
Rafael Lemes de Aquino ◽  
Lorena Silva Vargas ◽  
Adriana Lemos de Sousa Neto ◽  
Aline Maria Santos Maganhoto ◽  
Núbia Fernandes Teixeira
Keyword(s):  
Clinical Research ◽  
Study Design ◽  
Research Questions ◽  
Primary Focus

The book "Outlining Clinical Research" by Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady and Thomas B. Newman, translated by Michael Schimdt Duncan and André Garcia Islabão, and published, in 2015, by the publisher Artmed. As a primary focus, it is the instrumentalization of readers so that they can formulate research questions and plan an effective, systemic and ethical study design.

The Social Value of Research and Health Research Priority-Setting

2021 ◽  
Author(s):  
D.M. Wenner
Keyword(s):  
Clinical Research ◽  
Priority Setting ◽  
Health Research ◽  
Human Subjects ◽  
Social Value ◽  
Research Priority ◽  
The Social ◽  
Research Questions ◽  
Social Scientific ◽  
Health Research Priority Setting

This chapter discusses the social value requirement in clinical research and its intersection with health research priority-setting. The social value requirement states that clinical research involving human subjects is only ethical if it has the potential to produce socially valuable knowledge. The chapter discusses various ways to specify both the justification for and the content of the social value requirement. It goes on to consider the implications of various accounts of the content and justification for the requirement for the ethics of health research priority-setting, showing that while some accounts of the requirement are largely silent with respect to how research questions should be prioritized, others entail robust obligations to prioritize research that might benefit particular groups. The chapter also briefly examines potential arguments for something like a social value requirement in other kinds of research, specifically social scientific research.

scholarly journals Matching research design to clinical research questions

2012 ◽  
Vol 33 (1) ◽  
pp. 49 ◽  
Author(s):  
Sadaf Aslam ◽  
Kedar Mehta ◽  
Helen Georgiev ◽  
Ambuj Kumar
Keyword(s):  
Clinical Research ◽  
Research Design ◽  
Research Questions

scholarly journals Estimands: bringing clarity and focus to research questions in clinical trials

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e052953
Author(s):  
Timothy Peter Clark ◽  
Brennan C Kahan ◽  
Alan Phillips ◽  
Ian White ◽  
James R Carpenter
Keyword(s):  
Clinical Trial ◽  
Sensitivity Analysis ◽  
Clinical Trials ◽  
Clinical Research ◽  
Recent Work ◽  
Treatment Effect ◽  
Research Question ◽  
Probability Of Success ◽  
Research Questions

Precise specification of the research question and associated treatment effect of interest is essential in clinical research, yet recent work shows that they are often incompletely specified. The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials introduces a framework that supports researchers in precisely and transparently specifying the treatment effect they aim to estimate in their clinical trial. In this paper, we present practical examples to demonstrate to all researchers involved in clinical trials how estimands can help them to specify the research question, lead to a better understanding of the treatment effect to be estimated and hence increase the probability of success of the trial.

scholarly journals Reporting Standards for Clinical and Translational Research

2019 ◽  
pp. 69-73
Author(s):  
Fengyu Zhang ◽  
Claude Hughes
Keyword(s):  
Clinical Research ◽  
Study Design ◽  
Repeated Measurements ◽  
Sufficient Information ◽  
Reporting Standards ◽  
Preclinical Research ◽  
Study Protocols ◽  
Real World Evidence ◽  
Funding Agencies ◽  
Rigorous Study

Transparency in reporting the results of clinical and preclinical research is critical for unbiased publications. Funding agencies, publishers, and regulators have the responsibility to advocate and implement reporting standards for rigorous design. While individual study protocols may have included these standards, the items reported in the respective publications have often been inconsistent or lack transparency. This editorial intends to provide some specific guidelines for reporting results of clinical research with standards required for rigorous study design. We recommend that reporting clinical research should include sufficient information on study design and analysis plan that contains data processing, quality assurance, and appropriate methods used for rigorous statistical analysis or modeling. Any discrepancy between publications and original study design should be disclosed and discussed. Additionally, recent advances in the analysis of outcome with repeated measurements and statistical modeling should be employed to obtain unbiased estimates. Finally, we briefly discuss some issues reporting real-world evidence in clinical research.

Natural Experiments in Business Research Methods

2021 ◽  
Author(s):  
Michael C. Withers ◽  
Chi Hon Li
Keyword(s):  
Study Design ◽  
Methodological Approach ◽  
Secondary Data ◽  
Control Group ◽  
Causal Relationships ◽  
Random Assignment ◽  
Natural Experiments ◽  
Theoretical Understanding ◽  
Research Questions ◽  
Viable Approach

Causal identification is an important consideration for organizational researchers as they attempt to develop a theoretical understanding of the causes and effects of organizational phenomena. Without valid causal identification, insights regarding organizational phenomena are challenging given their inherent complexity. In other words, organizational research will be limited in its scientific progression. Randomized controlled experiments are often suggested to provide the ideal study design necessary to address potential confounding effects and isolate true causal relationships. Nevertheless, only a few research questions lend themselves to this study design. In particular, the full randomization of subjects in the treatment and control group may not be possible due to the empirical constraints. Within the strategic management area, for example, scholars often use secondary data to examine research questions related to competitive advantage and firm performance. Natural experiments are increasingly recognized as a viable approach to identify causal relationships without true random assignment. Natural experiments leverage external sources of variation to isolate causal effects and avoid potentially confounding influences that often arise in observational data. Natural experiments require two key assumptions—the as-if random assignment assumption and the stable unit treatment value assumption. When these assumptions are met, natural experiments can be an important methodological approach for advancing causal understanding of organizational phenomena.

Comments on Bulterman-Bos: Education Research as a Distributed Activity Across Universities

2008 ◽  
Vol 37 (7) ◽  
pp. 424-428 ◽  
Author(s):  
Ellen Condliffe Lagemann
Keyword(s):  
Education Research ◽  
Problem Solving ◽  
Clinical Research ◽  
Research Universities ◽  
Policy Makers ◽  
Problem Finding ◽  
Finding Study ◽  
Research Questions ◽  
Good Research

In response to Bulterman-Bos (2008) , this article discusses three kinds of research needed in education: problem-finding research, which helps frame good research questions; problem-solving research, which helps illuminate educational problems; and translational work, which transforms the findings of research into tools that practitioners and policy makers need. Clinical research is most important as a form of problem-finding study. Although it is best carried on in “ed schools,” other kinds of education research are best done in other faculties. For this reason, education research should be a distributed activity, encouraged across all the faculties of research universities.

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