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
Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stefan Rennick-Egglestone

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.


2017 ◽  
Vol 1 (S1) ◽  
pp. 82-82
Author(s):  
Meghan Spiroff ◽  
Lisa Connally ◽  
Anita Johnson ◽  
Aalap Doshi ◽  
Patricia Piechowski

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.


2016 ◽  
Vol 10 (2) ◽  
pp. 145-147 ◽  
Author(s):  
Jessica Whitburn ◽  
Surjeet Singh ◽  
Prasanna Sooriakumaran

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.


2021 ◽  
Author(s):  
Sophie Anne Ines Klofenstein ◽  
Carina Nina Vorisek ◽  
Aliaksandra Shutsko ◽  
Moritz Lehne ◽  
Julian Sass ◽  
...  

Adopting international standards within health research communities can elevate data FAIRness and widen analysis possibilities. The purpose of this study was to evaluate the mapping feasibility against HL7® Fast Healthcare Interoperability Resources® (FHIR)® of a generic metadata schema (MDS) created for a central search hub gathering COVID-19 health research (studies, questionnaires, documents = MDS resource types). Mapping results were rated by calculating the percentage of FHIR coverage. Among 86 items to map, total mapping coverage was 94%: 50 (58%) of the items were available as standard resources in FHIR and 31 (36%) could be mapped using extensions. Five items (6%) could not be mapped to FHIR. Analyzing each MDS resource type, there was a total mapping coverage of 93% for studies and 95% for questionnaires and documents, with 61% of the MDS items available as standard resources in FHIR for studies, 57% for questionnaires and 52% for documents. Extensions in studies, questionnaires and documents were used in 32%, 38% and 43% of items, respectively. This work shows that FHIR can be used as a standardized format in registries for clinical, epidemiological and public health research. However, further adjustments to the initial MDS are recommended – and two additional items even needed when implementing FHIR. Developing a MDS based on the FHIR standard could be a future approach to reduce data ambiguity and foster interoperability.


2008 ◽  
Vol 15 (2) ◽  
pp. 183-195
Author(s):  
Valerie Junod

AbstractMedical research on minors entails both risks and benefits. Under Swiss law, clinical trials on children, including nontherapeutic drug trials, are permissible. However, ethics committees must systematically verify that all clinical studies have a favorable risk-benefit profile. Additional safeguards are designed to ensure that children are not unnecessarily involved in research and that proper consent is always obtained. Federal Swiss law is undergoing revision to extend these protections beyond clinical trials to a broad array of health research. The Swiss drug agency also seeks to improve the incentives for pharmaceutical firms to develop new paediatric drugs and relevant paediatric drug labels.


Maturitas ◽  
2009 ◽  
Vol 63 (1) ◽  
pp. 4-6 ◽  
Author(s):  
Iveta Simera ◽  
David Moher ◽  
John Hoey ◽  
Kenneth F. Schulz ◽  
Douglas G. Altman

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