Expression profiling — best practices for data generation and interpretation in clinical trials

2004 ◽  
Vol 5 (3) ◽  
pp. 229-237 ◽  
Author(s):  
Keyword(s):  
Clinical Trials ◽  
Best Practices ◽  
Expression Profiling ◽  
Data Generation

Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

2021 ◽  
Vol 10 (1) ◽  
pp. 33-36
Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practices ◽  
Situational Awareness ◽  
Implantable Devices ◽  
Wearable Device ◽  
Sleep Habits ◽  
Privacy Issues ◽  
Trial Participants ◽  
Device Technology

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

scholarly journals Best Practices for Technical Reproducibility Assessment of Multiplex Immunofluorescence

2021 ◽  
Vol 8 ◽  
Author(s):  
Caddie Laberiano-Fernández ◽  
Sharia Hernández-Ruiz ◽  
Frank Rojas ◽  
Edwin Roger Parra
Keyword(s):  
Best Practices ◽  
Signal Amplification ◽  
Data Generation ◽  
Technical Requirements ◽  
Analysis Strategies ◽  
Technical Reproducibility ◽  
High Flexibility ◽  
Correct Data ◽  
Cancer Studies ◽  
Single Slide

Multiplex immunofluorescence (mIF) tyramide signal amplification is a new and useful tool for the study of cancer that combines the staining of multiple markers in a single slide. Several technical requirements are important to performing high-quality staining and analysis and to obtaining high internal and external reproducibility of the results. This review manuscript aimed to describe the mIF panel workflow and discuss the challenges and solutions for ensuring that mIF panels have the highest reproducibility possible. Although this platform has shown high flexibility in cancer studies, it presents several challenges in pre-analytic, analytic, and post-analytic evaluation, as well as with external comparisons. Adequate antibody selection, antibody optimization and validation, panel design, staining optimization and validation, analysis strategies, and correct data generation are important for reproducibility and to minimize or identify possible issues during the mIF staining process that sometimes are not completely under our control, such as the tissue fixation process, storage, and cutting procedures.

Best Practices for the Design of Clinical Trials Related to the Visual System

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Maureen G. Maguire
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Data Analysis ◽  
Best Practices ◽  
Visual System ◽  
Science Volume ◽  
Annual Review ◽  
Publication Date ◽  
Single Patient ◽  
Vision Science

Clinical trials for conditions affecting the visual system need to not only conform to the guidelines for all clinical trials, but also accommodate the possibility of both eyes of a single patient qualifying for the trial. In this review, I present the interplay of the key components in the design of a clinical trial, along with the modifications or options that may be available for trials addressing ocular conditions. Examples drawn from published reports of the design and results of clinical trials of ocular conditions are provided to illustrate application of the design principles. Current approaches to data analysis and reporting of trials are outlined, and the oversight and regulatory procedures to protect participants in clinical trials are discussed. Expected final online publication date for the Annual Review of Vision Science, Volume 7 is September 2021. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

scholarly journals 2520

2017 ◽  
Vol 1 (S1) ◽  
pp. 82-82
Author(s):  
Meghan Spiroff ◽  
Lisa Connally ◽  
Anita Johnson ◽  
Aalap Doshi ◽  
Patricia Piechowski
Keyword(s):  
Clinical Trials ◽  
Best Practices ◽  
Health Research ◽  
Participant Recruitment ◽  
Gender And Age ◽  
Study Population ◽  
Gender And Age Differences ◽  
The University ◽  
Racial Ethnic ◽  
Research Studies

OBJECTIVES/SPECIFIC AIMS: Across the Clinical and Translational Science Award (CTSA) Consortium, participant recruitment into clinical trials is essential to advance science. Without proper participant recruitment, clinical trials do not result in gains in scientific knowledge, wastes time, funds, and other resources (Mahon et al., 2015). METHODS/STUDY POPULATION: Participant recruitment programs across the consortium are inconsistent in staffing, program services, and program goals. The participant recruitment program at the University of Michigan’s (U-M) Michigan Institute for Clinical & Health Research (MICHR) provides expertise, tools, and resources to facilitate participant recruitment in clinical and health research studies. RESULTS/ANTICIPATED RESULTS: We will explain our program infrastructure, staffing, services, and discuss how we maintain an engaged registry with over 27,000 participants interested in research studies at U-M. DISCUSSION/SIGNIFICANCE OF IMPACT: Proper recruitment into clinical trials results in findings that are relevant for genetic, cultural, linguistic, racial/ethnic, gender, and age differences (Cottler et al., 2013). We hope to share our best practices that aid in the development and success of participant recruitment across the CTSA Consortium.

Implementing Precision Medicine Programs and Clinical Trials in the Community-Based Oncology Practice: Barriers and Best Practices

2018 ◽  
pp. 188-196 ◽  
Author(s):  
Jennifer L. Ersek ◽  
Lora J. Black ◽  
Michael A. Thompson ◽  
Edward S. Kim
Keyword(s):  
Clinical Trials ◽  
Best Practices ◽  
Precision Medicine ◽  
Community Setting ◽  
Successful Implementation ◽  
Precision Oncology ◽  
Community Based ◽  
Molecular Tests ◽  
Core Components ◽  
Oncology Practice

There has been a rapid uptick in the pace of oncology precision medicine advancements over the past several decades as a result of increasingly sophisticated technology and the ability to study more patients through innovative trial designs. As more precision oncology approaches are developed, the need for precision medicine trials is increasing in the community setting, where most patients with cancer are treated. However, community-based practices, as well as some academic centers, may face unique barriers to implementing precision medicine programs and trials within their communities. Such challenges include understanding the tissue needs of molecular tests (e.g., tumor, blood), identifying which molecular tests are best used and when tissue should be tested, interpreting the test results and determining actionability, understanding the role of genetic counseling and/or follow-up testing, determining clinical trial eligibility, and assessing patient attitudes and financial concerns. The purpose of this article is to provide guidance to community-based oncology practices currently conducting clinical trials who want to expand their research program to include precision medicine trials. Here, we describe the core components of precision medicine programs and offer best practices for successful implementation of precision medicine trials in community-based practices.

Gene Expression Profiling for Discovery of Novel Targets in Human Traumatic Brain Injury

2010 ◽  
Vol 13 (2) ◽  
pp. 140-153 ◽  
Author(s):  
Taura L. Barr ◽  
Sheila Alexander ◽  
Yvette Conley
Keyword(s):  
Gene Expression ◽  
Traumatic Brain Injury ◽  
Clinical Trials ◽  
Brain Injury ◽  
Gene Expression Profiling ◽  
Expression Profiling ◽  
Treatment Strategies ◽  
Biological Pathways ◽  
Human Response ◽  
Novel Targets

Several clinical trials have failed to demonstrate a significant effect on outcome following human traumatic brain injury (TBI) despite promising results obtained in preclinical animal studies. These failures may be due in part to a misinterpretation of the findings obtained in preclinical animal models of TBI, a misunderstanding of the complexity of the human response to TBI, limited knowledge about the biological pathways that interact to contribute to good and bad outcomes after brain injury, and the effects of genomic variability and environment on individual recovery. Recent publications suggest that data obtained from gene expression profiling studies of complex neurological diseases such as stroke, multiple sclerosis (MS), Alzheimer’s and Parkinson’s may contribute to a more informed understanding of what affects outcome following TBI. These data may help to bridge the gap between successful preclinical studies and negative clinical trials in humans to reveal novel targets for therapy. Gene expression profiling has the capability to identify biomarkers associated with response to TBI, elucidate complex genetic interactions that may play a role in outcome following TBI, and reveal biological pathways related to brain health. This review highlights the current state of the literature on gene expression profiling for neurological disease and discusses its ability to aid in unraveling the variable human response to TBI and the potential for it to offer treatment strategies in an area where we currently have limited therapeutic options primarily based on supportive care.

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