scholarly journals Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease

2021 ◽  
Vol 12 ◽  
Author(s):  
Swati Sathe ◽  
Jen Ware ◽  
Jamie Levey ◽  
Eileen Neacy ◽  
Robi Blumenstein ◽  
...  
Keyword(s):  
Informed Consent ◽  
Observational Study ◽  
Clinical Research ◽  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Clinical Database ◽  
Consent Forms ◽  
Online Portal ◽  
Research Platform ◽  
Contractual Agreements

Established in July 2012, Enroll-HD is both an integrated clinical research platform and a worldwide observational study designed to meet the clinical research requirements necessary to develop therapeutics for Huntington's disease (HD). The platform offers participants a low-burden entry into HD research, providing a large, well-characterized, research-engaged cohort with associated clinical data and biosamples that facilitates recruitment into interventional trials and other research studies. Additional studies that use Enroll-HD data and/or biosamples are built into the platform to further research on biomarkers and outcome measures. Enroll-HD is now operating worldwide in 21 countries at 159 clinical sites across four continents—Europe, North America, Latin America, and Australasia—and has recruited almost 25,000 participants, generating a large, rich clinical database with associated biosamples to expedite HD research; any researcher at a verifiable research organization can access the clinical datasets and biosamples from Enroll-HD and nested studies. Important operational features of Enroll-HD include a strong emphasis on standardization, data quality, and protecting participant identity, a single worldwide study protocol, a flexible EDC system capable of integrating multiple studies, a comprehensive monitoring infrastructure, an online portal to train and certify site personnel, and standardized study documents including informed consent forms and contractual agreements.

scholarly journals Data Analytics from Enroll-HD, a Global Clinical Research Platform for Huntington's Disease

2016 ◽  
Vol 4 (2) ◽  
pp. 212-224 ◽  
Author(s):  
Georg B. Landwehrmeyer ◽  
Cheryl J. Fitzer-Attas ◽  
Joseph D. Giuliano ◽  
Nilza Gonçalves ◽  
Karen E. Anderson ◽  
...  
Keyword(s):  
Clinical Research ◽  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Data Analytics ◽  
Research Platform

I30 Enroll-HD: a global clinical research platform for huntington’s disease

2016 ◽  
Vol 87 (Suppl 1) ◽  
pp. A69.1-A69
Author(s):  
Olivia Handley ◽  
Tiago Mestre ◽  
Jamie Levey ◽  
Tim McLean ◽  
Bernhard Landwehrmeyer ◽  
...  
Keyword(s):  
Clinical Research ◽  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Research Platform

scholarly journals Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research

2017 ◽  
Vol 12 (1) ◽  
pp. 14-25 ◽  
Author(s):  
Amy Corneli ◽  
Emily Namey ◽  
Monique P. Mueller ◽  
Jenae Tharaldson ◽  
Steve Sortijas ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Evidence Based ◽  
Online Surveys ◽  
Consent Forms ◽  
Modified Delphi ◽  
Key Stakeholders ◽  
Semistructured Interviews ◽  
Prevention Trials ◽  
Grouping Study

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants’ understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

scholarly journals Reduced penetrance alleles for Huntington's disease: a multi-centre direct observational study

2006 ◽  
Vol 44 (3) ◽  
pp. e68-e68 ◽  
Author(s):  
O. W J Quarrell ◽  
A. S Rigby ◽  
L Barron ◽  
Y Crow ◽  
A Dalton ◽  
...  
Keyword(s):  
Observational Study ◽  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Reduced Penetrance

HDinHD: A Rich Data Portal for Huntington’s Disease Research

2021 ◽  
pp. 1-8
Author(s):  
Jeff Aaronson ◽  
Vahri Beaumont ◽  
Richard A. Blevins ◽  
Viktoria Andreeva ◽  
Irina Murasheva ◽  
...  
Keyword(s):  
Huntington's Disease ◽  
Huntington’S Disease ◽  
Scientific Data ◽  
High Definition ◽  
Related Data ◽  
Online Portal ◽  
Wide Range ◽  
Data Portal ◽  
Rich Data

HDinHD (Huntington’s Disease in High Definition; HDinHD.org) is an open online portal for the HD research community that presents a synthesized view of HD-related scientific data. Here, we present a broad overview of HDinHD and highlight the newly launched HDinHD Explorer tool that enables researchers to discover and explore a wide range of diverse yet interconnected HD-related data. We demonstrate the utility of HDinHD Explorer through data mining of a single collection of newly released in vivo therapeutic intervention study reports alongside previously published reports.

scholarly journals Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yanni Wu ◽  
Michelle Howarth ◽  
Chunlan Zhou ◽  
Mingyu Hu ◽  
Weilian Cong
Keyword(s):  
Informed Consent ◽  
Observational Study ◽  
Clinical Research ◽  
Clinical Studies ◽  
Human Subjects ◽  
Retrospective Observational Study ◽  
Ethical Review ◽  
Journal Citation Reports ◽  
International Nursing ◽  
Ethical Approval

Abstract Background Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P < 0.05). Conclusion The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.

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