Open Access Platforms for Sharing Clinical Trial Data—Reply

JAMA ◽  
2016 ◽  
Vol 316 (6) ◽  
pp. 666 ◽  
Author(s):  
Ann Marie Navar ◽  
Michael J. Pencina ◽  
Eric D. Peterson
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Clinical Trial Data ◽  
Trial Data

Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute–Bristol-Myers Squibb Supporting Open Access to Researchers Initiative

2016 ◽  
Vol 172 ◽  
pp. 64-69 ◽  
Author(s):  
Michael J. Pencina ◽  
Darcy M. Louzao ◽  
Brian J. McCourt ◽  
Monique R. Adams ◽  
Rehbar H. Tayyabkhan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Clinical Research ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Research Institute

Open Access Platforms for Sharing Clinical Trial Data

JAMA ◽  
2016 ◽  
Vol 316 (6) ◽  
pp. 666 ◽  
Author(s):  
Joseph S. Ross ◽  
Harlan M. Krumholz
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Clinical Trial Data ◽  
Trial Data

scholarly journals What are the Usage Dimensions of Open?

2016 ◽  
Vol 1 ◽  
Author(s):  
Eric Archambault ◽  
Lorcan Dempsey ◽  
Christopher Erdmann ◽  
Stephanie Fulton ◽  
Dee Magnoni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Open Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Discovery Potential ◽  
Usage Dimensions

What are the usage-related challenges currently faced by open efforts? For instance, open data is intriguing in principle, but in reality, making underlying data open can be problematic, conflicting with the need for research secrecy (whether driven by the desire to be first to publish, or the desire of funders to hold onto data to protect future discovery potential), the potential for misinterpretation by other researchers, and so on. Publishing clinical trial data in open formats is also intriguing but would run afoul of many current consent agreements, particularly older consents. Open access is similarly challenged in some instances by a conflict between which version of papers is allowed appear in open repositories. What is the value of archiving non-final versions? What are the range of issues here, what are the perspectives, and what might be some possible solutions?

scholarly journals Report from the Usage Dimensions of Open Workgroup

2016 ◽  
Vol 1 ◽  
Author(s):  
Eric Archambault ◽  
Lorcan Dempsey ◽  
Christopher Erdmann ◽  
Stephanie Fulton ◽  
Dee Magnoni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Open Data ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Discovery Potential ◽  
Short And Long Term ◽  
Economic Considerations ◽  
Usage Dimensions

The Usage Dimensions of Open workgroup came together and considered definitions and priorities around its topic. From priorities, themes were identified. One theme included the character of research outputs and the actual research workflow process. The second theme represented economic considerations. Stakeholders were identified, and solutions consid­ered. Solutions included both short- and long-term actions.OSI2016 Workgroup QuestionWhat are the usage-related challenges currently faced by open efforts? For instance, open data is intriguing in principle, but in reality, making underlying data open can be problematic, con­flicting with the need for research secrecy (whether driven by the desire to be first to publish, or the desire of funders to hold onto data to protect future discovery potential), the potential for misinterpretation by other researchers, and so on. Publishing clinical trial data in open formats is also intriguing but would run afoul of many current consent agreements, particularly older consents. Open access is similarly challenged in some instances by a con­flict between which versions of papers is allowed to appear in open repositories. What is the value of archiving non-final versions? What is the range of issues here, what are the perspec­tives, and what might be some possible solutions?

scholarly journals The ideal repository for hosting data from clinical trials: blueprint using business process management

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 23
Author(s):  
Mirko Gabelica ◽  
Damir Sapunar ◽  
Matko Marušić ◽  
Livia Puljak
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Business Process ◽  
Business Process Management ◽  
Process Management ◽  
Process Analysis ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Whole Process ◽  
Business Process Analysis

In this article, we suggest a blueprint for an ideal open-access repository for clinical trial data with a description of a model of such a repository using a business process analysis approach. Firstly, we suggested which features an ideal repository should have. Secondly, we used business process management software to describe the whole process, from the decision to share clinical trial data to either publication of data in a repository or discarding data. The research community, legislators and society at large should be interested in a transparent open-access repository that will host clinical trial data. We hope this work can inspire relevant stakeholders to engage in discussion about the necessity of creating such repository, and that we will witness the creation of such a repository in the near future.

scholarly journals Use of Open Access Platforms for Clinical Trial Data

JAMA ◽  
2016 ◽  
Vol 315 (12) ◽  
pp. 1283 ◽  
Author(s):  
Ann Marie Navar ◽  
Michael J. Pencina ◽  
Jennifer A. Rymer ◽  
Darcy M. Louzao ◽  
Eric D. Peterson
Keyword(s):  
Clinical Trial ◽  
Open Access ◽  
Clinical Trial Data ◽  
Trial Data

scholarly journals Open Access Platforms in Spinal Cord Injury: Existing Clinical Trial Data to Predict and Improve Outcomes

2017 ◽  
Vol 31 (5) ◽  
pp. 399-401 ◽  
Author(s):  
John L. K. Kramer ◽  
Fred Geisler ◽  
Leanne Ramer ◽  
Ward Plunet ◽  
Jacquelyn J. Cragg
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Open Access ◽  
Clinical Trial Data ◽  
Research Community ◽  
Trial Data ◽  
Reliable Prediction ◽  
Cord Injury ◽  
Lateral Sclerosis

Recovery from acute spinal cord injury (SCI) is characterized by extensive heterogeneity, resulting in uncertain prognosis. Reliable prediction of recovery in the acute phase benefits patients and their families directly, as well as improves the likelihood of detecting efficacy in clinical trials. This issue of heterogeneity is not unique to SCI. In fields such as traumatic brain injury, Parkinson’s disease, and amyotrophic lateral sclerosis, one approach to understand variability in recovery has been to make clinical trial data widely available to the greater research community. We contend that the SCI community should adopt a similar approach in providing open access clinical trial data.

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