This infographic is a visual and appealing way to understand why open-source Electronic Data Capture (EDC) is an alternative of choice to proprietary systems or paper-based studies. Do you own a website, a forum or a blog on clinical trials or Electronic Data Capture (EDC) ? You are invited to share this infographic with your readers! How? Simply copy this code to your page: <a href=”http://blog.clinovo.com/new-infographic-why-choose-open-source-edc/”><img alt=”Infographic: Why choose open-source EDC?” choose=”open-source=” src=”http://blog.clinovo.com/wp-content/uploads/2013/05/infographic-2-resized.png” style=”height: 1817px; width: 675px;” why=”" /></a>[Source: <a href="http://blog.clinovo.com" title="Infographic: Why choose open-source EDC?">eClinical Trends by Clinovo</a>]
Clinovo releases its open-source community for users of ClinCapture® and developers around the world to collaborate on the enhancement of its open-source Electronic Data Capture (EDC) system.
ClinCapture’s® open-source community brings users and developers together to constantly enhance the EDC system and better meet the needs of life science companies. ClinCapture® is the most advanced open-source Electronic Data Capture (EDC) system. It is tailored to meet the needs of life science companies looking to run cost-effective phase I to IV clinical trials, investigator and registry studies.
“I strongly believe open-source is the future of clinical trials”, explains Marc Desgrousilliers, CTO at Clinovo. Clinovo envisions to develop new top-of-the-edge features, increase ClinCapture’s® performance and bring user experience to the next level.” Users and developers’ involvement in ClinCapture’s® community will ultimately help deliver medical innovations faster to patients”.
Electronic Data Capture (EDC) developers can download ClinCapture® on clinovo.com/clincapture/community and start contributing their code. Clinical Data Managers, Site Monitors, Clinical Research Associates and Clinical Research Coordinators can submit their requirements and feedback, which will be added to the product roadmap, by posting their ideas on the new forum at clinovo.com/clincapture/forum.
Tom Hickerson, Senior EDC Manager at Clinovo and first open-source EDC expert, gave an interview on his 10 years of experience with open-source Electronic Data Capture (EDC). He explains the benefits of open-source EDC, describes the new feature enhancements added to ClinCapture®, and details the product roadmap for 2013. “We are looking at an ambitious roadmap for 2013, including a series of focused releases, in which community members will play an instrumental role”.
On average, bringing an approved new drug from initial private investment to a patient takes over 13 years and $1.9 billion, or an average of $146 million per year. In this context, ClinCapture’s® cost/benefit comparison makes it a solution of choice for sponsors looking to run cost-effective early phases clinical trials, investigator, post-marketing or registry studies.
ClinCapture® was launched by Clinovo in 2009. Electronic Data Capture has been a critical area of growth for Clinovo in the past years. Thirty studies are currently running on ClinCapture®, including pharma, biotech and medical device studies. ClinCapture® has been repeatedly chosen for its cost-efficiency, flexibility and advanced customization. Client case studies are available on clinovo.com/resource-center/case-studies.
ClinCapture® is an advanced and flexible open-source electronic data capture (EDC) platform designed to streamline clinical trials. As an open-source EDC solution, ClinCapture® is tailored to meet the needs of life science companies looking to run cost-effective clinical trials. Clinovo released a new stable version of ClinCapture® in January 2013. Clinovo introduced a series of advanced features to streamline data capture and improve clinical data quality and integrity, including new LiveReports for real-time monitoring. The release featured a more intuitive navigation, rationalized roles, and one-click access function to many of the routine functions like scheduling events and data entry.
Clinovo partners with life science companies to streamline their clinical trials, leveraging years of expertise in systems integration, open-source technology and industry standards. Clinovo provides Staffing Solutions, eClinical Systems and Biometrics Services including Clinical Data Management, Electronic Data Capture, CDISC mapping, SAS Programming and technical trainings.
Sophie McCallum, Marketing Manager
Clinical trials have become increasingly complex and, as a result, costly. Only 333 drugs and biologics have been approved between 2000 and 2010 due to stricter regulatory procedures while spending has increase by 15 in the same period of time.
The need for innovation is critical in the pharmaceutical and biotechnology industry. Life science companies and service providers are looking for innovative solutions to improve study performance and minimize their risks. This article will demonstrate how open source technology presents an innovative solution to this challenging environment, and ultimately helps bring medical innovations faster to patients.
What is open source? Open source is a type of software license. There are various types of open source licenses, but the common characteristic to all is allowing free distribution of the underlying source code. Famous open source systems include Linux, Apache, MySQL, and many others. Below is a definition of Open-Source Software:
- Free redistribution
- Source code
- Derived works
- Integrity of the author’s source code
- No discrimination against persons or groups
- No discrimination against fields of endeavor
- Distribution of license
- License must not be specific to a product
- License must not restrict other software
- License must be technology-neutral
Taken from Opensource.org. See http://opensource.org/docs/definition.php for an annotated description of the above points.
Open Source in the Clinical Trial Industry. Two pioneers in open source technology for clinical trials are Cynthia Brandt and Prakash Nadkarni of the YaleCenterfor Medical Informatics, with their TrialDB system (http://ycmi.med.yale.edu/trialdb/), an open-source Clinical Study Data Management System (CSDMS) for the storage and management of clinical data initiated in the 1990’s.
The US National Cancer Institute launched a wide-ranging, open-source friendly initiative named CaBIG (Cancer Biomedical Informatics Grid - https://cabig.nci.nih.gov), that aims to develop a collaborative information network to accelerate the detection, diagnosis, treatment, and prevention of cancer.
Open source software is also used for electronic data capture (OpenClinica, ClinCapture), clinical research (LabKey Server), Electronic health or medical record (OpenEMR), analysis (R project), and CDISC conversion (CDISC Express, OpenCDISC).
Benefits of open source technologies for clinical trials. While open source is prevalent in many industries, this technology is still emerging in the field of clinical trials. The development of open source technology in the clinical arena has been quickly growing. Eric Morrie, Manager for Clinical Programming in one of the worldwide leading medical device companies, shared his extensive experience on open source technologies at a Silicon Valley BioTalks (http://www.clinovo.com/biotalks/open-source/article). Eric explained how open source technologies save time, improve re-usability and simplify the customization of systems to a company’s needs.
- Provide state-of-the-art, cost-effective solutions
Proprietary systems for clinical data management are often too expensive for individual researchers and smaller companies. As a result, they often use slow, error-prone paper-based methods.
Ale Gicqueau, President and CEO of Clinovo, a CRO based in the Bay Area, explains that with open source technologies, the license fee for proprietary systems is no longer a barrier entry for small and mid-size companies (http://www.clinovo.com/biotalks/open-source/article). Open source clinical data management systems save money by eliminating the reliance of using expensive proprietary systems, while insuring the same levels of quality. It provides a means for smaller companies to access high quality technologies for clinical data management and comply with international regulatory standards.
- Avoids the risks of vendor lock-in
Proprietary systems lock a customer into a vendor’s product from which they cannot escape without substantial switching costs. Such dependence includes reliance for maintenance and support, and the necessity to accept version upgrades that the buyer may not need.
Widely adopted open source systems on the other hand have multiple vendors supporting it. Surveys demonstrate that early adopters of open source technologies are driven by the “reduced dependence on software vendors”, often seen as one of the most important advantages of open source technology.
- Enables a larger community to maintain and enhance the source code
The open source model enables quick improvements by giving access to the underlying source code to a large community of talented developers. In the open source community, developers are encouraged to produce derived works to enhance the existing source code.
“The Open Source community attracts very bright, very motivated developers”, explains the UK software consultancy company GB Direct (http://open-source.gbdirect.co.uk/migration/benefit.html). “Highly prized factors are clean design, reliability and maintainability, with adherence to standards and shared community values preeminent.”
A rising trend: Open source for electronic data capture: One of the most famous and number one open source system for clinical trials is OpenClinica, with a community of over 12,000 developers.EDC systems are often prohibitively expensive, ranging in the hundreds of thousands of dollars. As a result, open source technology has been particularly well-received in the field of electronic data capture. Open source EDC platforms deliver the same benefits as proprietary EDC systems but without the license fee.
The one I am most familiar with is an open source EDC system developed by Clinovo : ClinCapture. It is a validated and enhanced version of the #1 open source EDC platform, fully customizable to any clinical study. Learn more
This open source EDC system has been successfully implemented by major pharmaceutical, medical device and biotech companies. Victor Chen, Director of Clinical Affairs at Intuitive Surgical, explains that he decided to use this technology due to the low price and the flexibility that suits adaptive clinical trials. However, he emphasizes on the importance of rigorously assessing any open source system vs. proprietary systems and evaluating the cost for validation. Read case study
The emergence of open source based tools for CDISC: Converting clinical data to the widely recognized CDISC SDTM standard is often done manually, which can quickly become tedious, error-prone, and time-consuming.CDISC SDTM data is the standard format recommended by the FDA for clinical trial data submission. The mission of CDISC is to develop and support global, platform-independent data standards to improve medical research.
Clinovo developed an open-source system to help with this conversion to CDISC SDTM: CDISC Express. CDISC Express is a powerful open source SAS®-based system that automatically converts clinical data into CDISC SDTM using an Excel framework.
The CDISC Express framework is highly extensible. The system significantly speeds-up CDISC SDTM conversion, and has been successfully implemented for major biotechnology and pharmaceutical companies. Download for free
Conclusion: Today, it takes on average 10 to 15 years to develop a drug and costs near $1.2 billion. With only 2 of 10 marketed drugs returning revenues that match or exceed R&D costs, developing medical innovations has become more and more risky. Open source technologies are an innovative way to lower the cost of clinical trials and minimize risk, while ensuring the same level of quality as proprietary systems.
Ultimately, open source technologies increase the scope and variety of clinical trials, by enabling smaller institutions to pursue their clinical research that would otherwise be out-of-reach and beyond financial capacity. “We believe that an open-source approach has the best chance of ensuring that all kind of groups can be involved with the development of systems that have bearing on global public health”, explains Greg W. Fegan and Trudie A. Lang in their featured article Could an Open-Source Clinical Trial Data Management System Be What We Have All Been Looking For?
- Silicon Valley BioTalks, June 2011 : http://www.clinovo.com/node/129
- “Could an Open-Source Clinical Trial Data Management System Be What We Have All Been Looking For?”, By Greg W. Fegan and Trudie A. Lang, March 4, 2008
- “Overcoming Obstacles To Successful Clinical Trials through Open Source”, by Benjamin Baumann, Nov 10, 2011
- 2011 profile, PhRMA Pharmaceutical Industry
- Health Decision Webinar “Top 10 Benefits of Adaptive Design”, Jan 25, 2011
- CDISC Express: www.clinovo.com/cdisc
- ClinCapture brochure: http://www.clinovo.com/resources/brochures/clincapture
- Clinovo case studies on open source systems: http://www.clinovo.com/case_studies
We are organizing a networking event on open source technologies for clinical trials : Silicon Valley BioTalks ‘Run efficient clinical trials with open source techonlogies’
We noticed that the interest for open source technologies and practices has been growing in the clinical trial and biotech sectors.
The most frequent questions seem to be : What are the key benefits of open sources technologies for sponsors? What are the different open source products available today for clinical trials? What are the best practices for a successful implementation?
Representatives of Abbott Vascular, Intuitive Surgical and Clinovo will share their experience with open source technologies.
The event is taking place on June 29th in Palo Alto
You will find all details and the online registration form here
- Best Practices (3)
- Best-Practices (16)
- BioNews (3)
- Business Best Practices (5)
- Case studies (2)
- CDISC (11)
- Clinical Data Management (6)
- Clinical Stories (1)
- Code (13)
- EDC (7)
- Event (3)
- Events (7)
- Menu (3)
- Monthly Contest (12)
- New Technologies (15)
- OpenClinica (2)
- SAS Library (4)
- Scripting (2)
- Tips & Techniques (14)
- Trends (11)