Blood volumes in pediatric clinical trials: a review of current regulations and guidance for research studies

2014 ◽  
Vol 4 (11) ◽  
pp. 1005-1011 ◽  
Author(s):  
Gareth J Veal
Keyword(s):  
Clinical Trials ◽  
Blood Volumes ◽  
Research Studies

scholarly journals Principles for the production and dissemination of recruitment material for three clinical trials of an online intervention

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stefan Rennick-Egglestone
Keyword(s):  
Social Media ◽  
Clinical Trials ◽  
Health Research ◽  
Online Intervention ◽  
Ethics Committee ◽  
Promotional Material ◽  
Media Campaigns ◽  
Social Media Platforms ◽  
Ethical Oversight ◽  
Research Studies

AbstractSome health research studies recruit participants through electronic mechanisms such as the placement of messages on social media platforms. This raises questions for ethics committee oversight, since effective social media campaigns might involve the production and dissemination of hundreds of contemporaneous messages. For the Narrative Experiences Online (NEON) study, we have developed nine principles to control the production and dissemination of promotional material. These have been approved by an ethics committee and enable the audit of our recruitment work. We propose that the drafting for approval of recruitment principles by health research studies may, in many cases, strike an appropriate balance between enabling ethical oversight of online recruitment work and the potential burden of message review.

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.

scholarly journals Setting up clinical research studies in the National Health Service in England

2016 ◽  
Vol 10 (2) ◽  
pp. 145-147 ◽  
Author(s):  
Jessica Whitburn ◽  
Surjeet Singh ◽  
Prasanna Sooriakumaran
Keyword(s):  
Clinical Trials ◽  
National Health Service ◽  
Health Service ◽  
Research And Development ◽  
Clinical Research ◽  
National Health ◽  
Health Research ◽  
Application Process ◽  
Regulatory Bodies ◽  
Research Studies

Starting and conducting clinical trials in England can be a complicated and time-consuming process. Before your study can begin it is necessary to gain approval from the appropriate regulatory bodies. Prior to March 2016, studies required National Health Service (NHS) permission (also referred to as Research and Development (R&D) approval) obtained via the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP). Since March 2016, a new streamlined system has been introduced with the aim of making it easier to gain regulatory approvals. Now studies must go through the process of Health Research Authority (HRA) approval. In this article we review the process of gaining HRA approval in England. The article is aimed at junior researchers to help them understand the application process, and to give tips on how to succeed in gaining approval.

scholarly journals Impact of the COVID-19 pandemic on the oncologic activities (diagnosis, treatment, clinical trials enrollment) of a general hospital in a district with high prevalence of SARS-COV-2 in Italy

2022 ◽  
Author(s):  
Massimo Ambroggi ◽  
Chiara Citterio ◽  
Stefano Vecchia ◽  
Alessandra Riva ◽  
Patrizia Mordenti ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Cancer Patients ◽  
General Hospital ◽  
Cancer Diagnosis ◽  
Real World ◽  
Oral Treatment ◽  
The Real ◽  
High Prevalence ◽  
Research Studies

Abstract Purpose Little is known about the real impact of the COVID-19 outbreak on the qualitative and quantitative fall-out on the management of cancer patients. Our objective was to provide evidence of the effects of SARS-COV-2 on the management of cancer patients in the real world. Methods In a general hospital in a district in Italy with high prevalence of COVID-19 during the first wave, we retrospectively analyzed the data of oncologic activity, namely new cancer diagnosis, types of treatment (intravenous or by mouth), clinical research studies, and drug utilization, and compared the findings with those of 2019, before the pandemic. The data have been summarized in boxplot figures for median and interquartile range. Results In 2020, a significant reduction in new cancer diagnosis was demonstrated when compared with 2019, with 17.4% fewer cancer diagnoses, 84.5% fewer patients enrolled in clinical trials, a 10.6% reduction in intravenous antitumor treatment, and a 42.7% increase in oral anticancer treatment. Conclusion Our data indicate a significant reduction in cancer diagnosis, antitumor venous treatment, and patients enrolled in clinical research studies in 2020 compared with 2019, although there was a significant increase in oral treatment. These data suggest that the COVID-19 pandemic had a deep impact on the real-world management of cancer patients in a district of Italy with a high prevalence of COVID-19.

Negative Studies

2018 ◽  
pp. 72-74
Author(s):  
S. Nassir Ghaemi
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Impact Factors ◽  
Pharmaceutical Companies ◽  
Positive Direction ◽  
Bipolar Illness ◽  
Positive Data ◽  
Published Research ◽  
Depressive States ◽  
Research Studies

A major problem in clinical practice of psychopharmacology is that opinion often is influenced by published research studies that are biased in a positive direction. This bias occurs because negative clinical trials, which show inefficacy of a drug, tend to be unpublished, while positive clinical trials are published and often promoted heavily by pharmaceutical companies. And journals may also systematically reject negative studies—which will generate fewer readers, fewer citations, and lower impact factors for the journal—more frequently than positive ones. The example of lamotrigine is provided, where multiple negative trials, mostly unpublished, exist in acute depressive states and other mood subtypes, in contrast to positive data in maintenance prevention of bipolar illness.

scholarly journals Recruitment and Attrition Issues in Military Clinical Trials and Health Research Studies

2013 ◽  
Vol 178 (11) ◽  
pp. 1157-1163 ◽  
Author(s):  
Nigel E. Bush ◽  
Sean C. Sheppard ◽  
Emily Fantelli ◽  
Kathleen R. Bell ◽  
Mark A. Reger
Keyword(s):  
Clinical Trials ◽  
Health Research ◽  
Research Studies

scholarly journals Regulating impact on bystanders in clinical trials: An unsettled frontier

2019 ◽  
Vol 16 (5) ◽  
pp. 450-454
Author(s):  
Nir Eyal ◽  
Jonathan Kimmelman ◽  
Lisa G Holtzman ◽  
Marc Lipsitch
Keyword(s):  
At Risk ◽  
Clinical Trials ◽  
Medical Research ◽  
Research Ethics ◽  
Academic Scholarship ◽  
Ethics Guidelines ◽  
Study Participants ◽  
Research Ethics Guidelines ◽  
Research Studies

This article informally reviews key research ethics guidelines and regulations, academic scholarship, and research studies and finds wide variety in how they consider risk to bystanders in medical research (namely, non-participants whom studies nevertheless place at risk). Some of these key sources give no or very little consideration to bystanders, while others offer them the utmost protection (greater than they offer study participants). This unsettled frontier would benefit from a deeper investigation of the ethics of protecting research bystanders.

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