scholarly journals A framework for clinical and translational research in the era of rigor and reproducibility

2020 ◽  
pp. 1-10
Author(s):  
Chris Wichman ◽  
Lynette M. Smith ◽  
Fang Yu
Keyword(s):  
Data Analysis ◽  
Data Collection ◽  
Translational Research ◽  
Study Design ◽  
Clinical Translation ◽  
Multidisciplinary Teams ◽  
Scientific Practices ◽  
Design Data ◽  
Anaplastic Lymphoma ◽  
Clinical And Translational Research

Abstract Introduction: Rigor and reproducibility are two important cornerstones of medical and scientific advancement. Clinical and translational research (CTR) contains four phases (T1–T4), involving the translation of basic research to humans, then to clinical settings, practice, and the population, with the ultimate goal of improving public health. Here we provide a framework for rigorous and reproducible CTR. Methods: In this paper we define CTR, provide general and phase-specific recommendations for improving quality and reproducibility of CTR with emphases on study design, data collection and management, analyses and reporting. We present and discuss aspects of rigor and reproducibility following published examples of CTR from the literature, including one example that shows the development path of different treatments that address anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). Results: It is particularly important to consider robust and unbiased experimental design and methodology for analysis and interpretation for clinical translation studies to ensure reproducibility before taking the next translational step. There are both commonality and differences along the clinical translation research phases in terms of research focuses and considerations regarding study design, implementation, and data analysis approaches. Conclusions: Sound scientific practices, starting with rigorous study design, transparency, and team efforts can greatly enhance CTR. Investigators from multidisciplinary teams should work along the spectrum of CTR phases, and identify optimal practices for study design, data collection, data analysis, and results reporting to allow timely advances in the relevant field of research.

scholarly journals Massive Open Online Course Evaluation Methods: Systematic Review (Preprint)

2019 ◽  
Author(s):  
Abrar Alturkistani ◽  
Ching Lam ◽  
Kimberley Foley ◽  
Terese Stenfors ◽  
Elizabeth R Blum ◽  
...  
Keyword(s):  
Data Analysis ◽  
Data Collection ◽  
Quality Assessment ◽  
Study Design ◽  
Evaluation Methods ◽  
Course Evaluation ◽  
Data Sources ◽  
Massive Open Online ◽  
Analysis Methods ◽  
Data Analysis Methods

BACKGROUND Massive open online courses (MOOCs) have the potential to make a broader educational impact because many learners undertake these courses. Despite their reach, there is a lack of knowledge about which methods are used for evaluating these courses. OBJECTIVE The aim of this review was to identify current MOOC evaluation methods to inform future study designs. METHODS We systematically searched the following databases for studies published from January 2008 to October 2018: (1) Scopus, (2) Education Resources Information Center, (3) IEEE (Institute of Electrical and Electronic Engineers) Xplore, (4) PubMed, (5) Web of Science, (6) British Education Index, and (7) Google Scholar search engine. Two reviewers independently screened the abstracts and titles of the studies. Published studies in the English language that evaluated MOOCs were included. The study design of the evaluations, the underlying motivation for the evaluation studies, data collection, and data analysis methods were quantitatively and qualitatively analyzed. The quality of the included studies was appraised using the Cochrane Collaboration Risk of Bias Tool for randomized controlled trials (RCTs) and the National Institutes of Health—National Heart, Lung, and Blood Institute quality assessment tool for cohort observational studies and for before-after (pre-post) studies with no control group. RESULTS The initial search resulted in 3275 studies, and 33 eligible studies were included in this review. In total, 16 studies used a quantitative study design, 11 used a qualitative design, and 6 used a mixed methods study design. In all, 16 studies evaluated learner characteristics and behavior, and 20 studies evaluated learning outcomes and experiences. A total of 12 studies used 1 data source, 11 used 2 data sources, 7 used 3 data sources, 4 used 2 data sources, and 1 used 5 data sources. Overall, 3 studies used more than 3 data sources in their evaluation. In terms of the data analysis methods, quantitative methods were most prominent with descriptive and inferential statistics, which were the top 2 preferred methods. In all, 26 studies with a cross-sectional design had a low-quality assessment, whereas RCTs and quasi-experimental studies received a high-quality assessment. CONCLUSIONS The MOOC evaluation data collection and data analysis methods should be determined carefully on the basis of the aim of the evaluation. The MOOC evaluations are subject to bias, which could be reduced using pre-MOOC measures for comparison or by controlling for confounding variables. Future MOOC evaluations should consider using more diverse data sources and data analysis methods. INTERNATIONAL REGISTERED REPORT RR2-10.2196/12087

scholarly journals Tackling rare diseases: Clinical trials on chips

2020 ◽  
Vol 245 (13) ◽  
pp. 1155-1162 ◽  
Author(s):  
Sandra H Blumenrath ◽  
Bo Y Lee ◽  
Lucie Low ◽  
Ranjini Prithviraj ◽  
Danilo Tagle
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Collection ◽  
Rare Disease ◽  
Study Design ◽  
Rare Diseases ◽  
Working Group ◽  
Design Data ◽  
Chip Technology ◽  
Microphysiological Systems

Technological advances with organs-on-chips and induced pluripotent stem cells promise to overcome hurdles associated with developing medical products, especially for rare diseases. Organs-on-chips—bioengineered “microphysiological systems” that mimic human tissue and organ functionality—may overcome clinical trial challenges with real-world patients by offering ways to conduct “clinical trials-on-chips” (CToCs) to inform the design and implementation of rare disease clinical studies in ways not possible with other culture systems. If applied properly, CToCs can substantially impact clinical trial design with regard to anticipated key outcomes, assessment of clinical benefit and risk, safety and tolerability profiles, population stratification, value and efficiency, and scalability. To discuss how tissue chips are best used to move the development of rare disease therapies forward, a working group of experts from industry, academia, and FDA as well as patient representatives addressed questions related to disease setting, test agents for microphysiological systems, study design and feasibility, data collection and use, the benefits and risks associated with this approach, and how to engage stakeholders. While rare diseases with no current therapies were considered the ultimate target, participants cautioned against stepping onto too many unknown territories when using rare disease as initial test beds. Among the disease categories considered ideal for initial CToC tests were well-defined diseases with known clinical outcomes; diseases where tissues on chips can serve as an alternative to risky first-in-human studies, such as in pediatric oncology; and diseases that lend itself to immuno-engineering or genome editing. Participants also considered important challenges, such as hosting the chip technology in-house, the high variability of cell batches and the resulting regulatory concerns, as well as the financial risk associated with the new technology. To make progress in this area and increase confidence with the use of tissue chips, the re-purposing of approved drugs ought to be the very first step. Impact statement Designing and conducting clinical trials are extremely difficult in rare diseases. Adapting tissue chips for rare disease therapy development is pivotal in assuring that treatments are available, especially for severe diseases that are difficult to treat. Thus far, the NCATS-led National Institutes of Health (NIH) Tissue Chip program has focused on deploying the technology towards in vitro tools for safety and efficacy assessments of therapeutics. However, exploring the feasibility and best possible approach to expanding this focus towards the development phase of therapeutics is critical to moving the field of CToCs forward and increasing confidence with the use of tissue chips. The working group of stakeholders and experts convened by NCATS and the Drug Information Association (DIA) addresses important questions related to disease setting, test agents, study design, data collection, benefit/risk, and stakeholder engagement—exploring both current and future best use cases and important prerequisites for progress in this area.

PI-2Drug interaction studies -- study design, data analysis, and implications for dosing and labeling: Current opinion

2006 ◽  
Vol 79 (2) ◽  
pp. P7-P7 ◽  
Author(s):  
S HUANG ◽  
K REYNOLDS ◽  
J STRONG ◽  
S NALLANI ◽  
L LESKO ◽  
...  
Keyword(s):  
Data Analysis ◽  
Study Design ◽  
Design Data ◽  
Current Opinion ◽  
Interaction Studies

Authorship

2016 ◽  
Keyword(s):  
Medical Journal ◽  
Data Analysis ◽  
Data Collection ◽  
International Committee ◽  
Rapid Review ◽  
Design Data ◽  
Journal Editors ◽  
Collection Data ◽  
Honorary Authorship ◽  
Definition Of

This chapter begins with a definition of authorship and provides the The Proposed Rapid Review Checklist for Authors (the 5Ds: design, data collection, data analysis, discussion of findings, the ability to define the paper and its message) which may be useful in judging whether authorship should be considered. The authorship model proposed by the International Committee of Medical Journal Editors (ICMJE) is also outlined. The chapter also discusses different forms of inappropriate authorship models (ghost authorship, guest/honorary authorship, anonymous authorship) and presents intellectual property and copyright considerations. An author's responsibility to report an original, accurate, focused and repeatable account of the research conducted is also discussed.

scholarly journals Pengaruh Permainan Konstruktif Tangram terhadap Berfikir Kreatif pada Siswa Sekolah Dasar

2020 ◽  
Vol 12 (1) ◽  
pp. 37-50
Author(s):  
Jenny Nugraheni Irawan ◽  
Aditya Nanda Priyatama ◽  
Afia Fitriani
Keyword(s):  
Experimental Study ◽  
Elementary School ◽  
Data Analysis ◽  
Data Collection ◽  
Test Data ◽  
Creative Thinking ◽  
Design Data ◽  
Group Design ◽  
Before And After ◽  
Statistical Program

Tangram constructive game is one of the games that can be used to train creative thinking. The purpose of this study was to know the effect of tangram constructive game on creative thinking in elementary school student. The hypithesis of this study is that there is a significant effect of tangram constructive game on creative thinking before and after intervention. This research is an experimental study with nonequivalent crontrol group design. Data collection uses figural creativity test. Data analysis used the Mann-Withney technique with the SPSS statistical program. The result of the study show that the value of Z count = -2,363 with p = 0,18 (p<0,05). So, if can be concluded that there is a significant effect on creative thinking after intervention

scholarly journals Correction to: M1 macrophage dependent-p53 regulates the intracellular survival of mycobacteria

APOPTOSIS ◽  
2019 ◽  
Vol 25 (1-2) ◽  
pp. 56-56
Author(s):  
Yun-Ji Lim ◽  
Junghwan Lee ◽  
Ji-Ae Choi ◽  
Soo-Na Cho ◽  
Sang-Hun Son ◽  
...  
Keyword(s):  
Data Collection ◽  
Study Design ◽  
Medical Science ◽  
Original Version ◽  
Research Fund ◽  
Design Data ◽  
Data Collection And Analysis ◽  
M1 Macrophage ◽  
National University ◽  
The Brain

The original version of this article unfortunately contains an error in the acknowledgement section. The text “Brain Korea 21 PLUS Project for Medical Science, Chungnam National University” was omitted by mistake. The correct and complete acknowledgment is given below: Acknowledgments This work was supported by the research fund of Chungnam National University and the Brain Korea 21 PLUS Project for Medical Science, Chungnam National University. The funders had no role in study design, data collection and analysis decision to publish, or preparation of the manuscript.

scholarly journals Pengaruh Permainan Angka terhadap Kemampuan Berhitung Permulaan Kelompok B

2019 ◽  
Vol 6 (2) ◽  
pp. 84-90
Author(s):  
Iin Khoirotul Masruroh ◽  
Dwi Nurhayati Adhani ◽  
Dewi Mayangsari
Keyword(s):  
Decision Making ◽  
Data Analysis ◽  
Experimental Design ◽  
Data Collection ◽  
Design Data ◽  
Group Design ◽  
A Value ◽  
Analysis Technique ◽  
Parametric Statistics ◽  
Group B

This study aims to find out how the influence of the numbers play on the initial numeracy ability of group B in Muslimat 03 Roudlotut Tholibin Kindergarten Warukulon. The subjects of this study were 14 children. This study uses a quantitative approach using an experimental method with a pre-experimental design of the Pretest-posttest-Design One-Group design. Data collection techniques used are observation and documentation. The data analysis technique is in the form of non-parametric statistics in the form of a Wilcoxon level test with data from the pretest and posttest assessment results. The results of this study were obtained at the pretest that there were 5 children with undeveloped criteria (BB), and 8 children with criteria still developing (MB), and 1children the criteria developed according to expectations (BSH). Whereas in the posttest study 3 children with criteria for excellent development (BSB), and 8 children with criteria developed according to expectations (BSH), and there were 3 children with criteria still developing (MB). The calculation result using the Wilcoxon level test obtained a value of Tcount Ttable (021) that is T more than T table. So that the decision making is HO (Zero Hypotesis) is rejected and HA (Alternative Hypotesis) is accepted because Thitung Ttable (021). So that there is an influence on the numbers game on the initial numeracy skills at the Muslimat 03 kindergarten Roudlotut Tholibin Warukulon.

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