Navigation Links
PhUSE Announces Open Source Repository of Clinical Trial Informatics Analysis Code
Date:2/27/2013

Silver Spring, MD (PRWEB) February 27, 2013

PhUSE, a global non-profit community for the advancement of clinical informatics, invites contributions to an open source repository of computer programs, tools. The repository will be a major collaborative initiative that is open to use by academics, pharmaceutical and biotech personnel, and regulators.

The open source repository is one of a series of bold initiatives that were launched out of the March 2012 PhUSE/FDA Computational Science Symposium (CSS). The focus of the initiatives is to improve the collection, reporting and analysis of medical data.

An FDA spokesperson noted of the collaboration’s future work, “The CSS provides our FDA Reviewers and operational team an opportunity to share their experiences, collaborate with industry, and really work on the issues we have in the review process. Last year was the beginning of this great opportunity to collaborate and we hope more of our industry partners attend this year.”

There are great advantages to contributing to the open source repository. A collaborative approach between industry, regulators and academics should reduce time spent within individual organisations to develop systems and tools for analysis and reporting of clinical data. Aligning the tools and approaches to the analysis of clinical trial data between pharmaceutical industry personnel and regulators should also improve the ability of all parties to draw similar conclusions and results from data.

After a review of available options, the open source repository has been set up using the Google Code platform. A Call for Scripts has been issued asking for individuals and organisations to contribute to the initiative. Organisations and individuals that work with medical data are asked to consider contributing programs, tools and resources, although involvement as a user of code is also welcome.

The PhUSE vision for the future of this initiative is that the repository will become populated with useful tools, programs and resources that will be used across the statistics and computer programming community, building and strengthening existing CDISC standards. To further this vision, PhUSE has an on-going project to define what type of scripts and programs are needed, and to develop “white papers” to describe these requirements. Further calls will be issued relating to requests for development in specific topics of interest covered by these white papers. In the pharmaceutical industry, there is a perception that validated software is not compatible with an open source approach. PhUSE is continuing to work on processes to ensure that the repository can manage and store validated scripts.

Chris Decker, PhUSE FDA Liaison Director, stated “The ability to have an open and central repository for code within our industry would provide the last piece of the standardization puzzle. Over the last 10 years, we have developed and implemented the CDISC data standards. Now it’s time to take that last step of standardizing our analyses and code as much as possible.”

If you would like to get involved and learn more about this project, please investigate these resources:

Details of the project: http://www.phusewiki.org/wiki/index.php?title=User_Guide_for_Standard_Script_Repository

The Google Code Repository: https://code.google.com/p/phuse-scripts/

Contact the script repository managers: Email: code(at)phuse(dot)com

PhUSE, Share – Contribute – Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer supported, community of professionals who are passionate about advancement of clinical information. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals. http://www.phuse.eu

Read the full story at http://www.prweb.com/releases/2013/2/prweb10467007.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Dr. Ben Goldacre to Keynote PhUSE Annual Conference
2. Foundation for the NIH Announces Lurie Prize Recognizing Outstanding Achievement by a Young Biomedical Scientist
3. Auxilium Pharmaceuticals, Inc. Announces Fourth Quarter and Full Year 2012 Financial Results and Guidance for 2013
4. Innovative Therapies Inc (ITI) Announces New Executive Management Team of the Wound Care Therapy Division and New User Friendly Website
5. The Veterinary Bioscience Institute Announces its Roux-en-Y Gastric Bypass Surgery Model in Rodents
6. The Veterinary Bioscience Institute Announces a Mouse Surgery Webinar Series
7. Genomic Health Announces Results from Two Studies Demonstrating Innovations in Next Generation Sequencing From Paraffin Tissue, Enhancing Understanding of Tumor Biology
8. FibeRio® Technology Corporation Announces Strategic Investment Financing Led by SABIC and Aster Capital
9. DuPont Tate & Lyle Bio Products Announces Winner of Zemea® Innovation Award
10. Sensus Healthcare Announces its Exhibitor Attendance at the 71st Annual American Academy of Dermatology Meeting
11. Celsion Corporation Announces $15 Million Registered Direct Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/3/2016)... 2016   ViaCyte, Inc ., a leading, ... stem cell-derived islet replacement therapy for the treatment ... announced that ViaCyte and Janssen Biotech, Inc., one ... Johnson, have agreed to consolidate the assets of ... provides ViaCyte with an exclusive license to all ...
(Date:2/3/2016)... Mass., Feb. 3, 2016 Harvard Apparatus ... biotechnology company developing bioengineered organ implants for life-threatening ... announced that CEO Jim McGorry , will ... Conference on Tuesday, February 9, 2016 at ... City . HART,s presentation will be webcast ...
(Date:2/3/2016)... ... February 03, 2016 , ... StarNet Communications ... solutions today announced the addition of a powerful “Session Preview” feature to its ... current state of the remote Linux desktop or other applications (sessions) they have ...
(Date:2/3/2016)... ... February 03, 2016 , ... ... aid in the rapid development and ongoing quality control of molecular assays targeting ... is extremely high,” Dr. Gregory R. Chiklis, President and CEO of ZeptoMetrix, relayed ...
Breaking Biology Technology:
(Date:1/22/2016)... , January 22, 2016 /PRNewswire/ ... announced the addition of the  "Global ... their offering. --> http://www.researchandmarkets.com/research/4lmf2s/global_behavioral ... the  "Global Behavioral Biometric Market 2016-2020" ... Research and Markets ( http://www.researchandmarkets.com/research/4lmf2s/global_behavioral ) ...
(Date:1/20/2016)... Jan. 20, 2016  Synaptics Incorporated (NASDAQ: ... solutions, today announced sampling of S1423, its newest ... and small screen applications including smartwatches, fitness trackers, ... round and rectangular shapes, as well as thick ... with moisture on screen, while wearing gloves, and ...
(Date:1/11/2016)... , Jan. 11, 2016 Synaptics Incorporated ... interface solutions, today announced that its ClearPad ® ... (TDDI) products won two separate categories in the 8 ... Innovator and Best Technology Breakthrough. The Synaptics ® ... a simplified supply chain, thinner devices, brighter displays and ...
Breaking Biology News(10 mins):