Adventures in Web-Based Electronic Data Capture (EDC) – An OpenClinica Case Study

A recent issue of Applied Clinical Trials Online features a case study of OpenClinica Electronic Data Capture (EDC) adoption by German device company, Retina Implant, AG. Here’s a short excerpt:

“Last summer, Retina Implant started using OpenClinica for its latest trial, which is comprised of 11 studies. Currently, five of those studies have acquired subjects and are up and running with the OpenClinica CRF process. Randomization of study subjects are done outside OpenClinica, as it doesn’t have this feature. So far, Hekmat is appreciative of the flexibility of the platform, its ease of use among the global site staff, and the ability to view data in real-time via the Web browser.”

Click here for the full article.

Clinical Research and the Cloud…two great things that don’t go together (yet).

Cloud computing seems to have become the best thing since sliced bread for most startups. With the arrival of Amazon Web Services and Google Apps, we have seen the rise of “pay-as-you-go, on-demand basis” for all aspects of IT infrastructure, including storage, servers, and processing speed. Already several startups have bet the farm on the cloud to pay off (Heroku is one example, joined by Twitter, SmugMug, and Scribd). Bigger players have also banked on cloud computing: Apple’s MobileMe service is the most recently cited example of working with consumers in the cloud.

Earlier this month, I read a post over at GigaOM entitled “10 Reasons Enterprises Aren’t Ready to Trust the Cloud“. The article busts through a lot of the gee-whiz aspects of cloud computing and brings us back to reality. Some of the points the article makes include:

  • Security – this is the big issue. The article even goes so far as to mention HIPAA by name, since it is that important for PHI, including clinical data.
  • Lack of auditing – another big issue, especially in the clinical trials space.
  • Reliability – what happens when it goes down? More on that issue in a moment.
  • It still has to exist on a server somewhere – what are the legal complications of hosting PHI in a server farm that could be in say, Russia?
  • And oh yes, it still has to be fast – as the article says, “the need for speed still exists” in companies, and not all of the cloud can address that issue.

This piece was eerily prescient, because after I started a draft of this post, Amazon E3 went down, taking with it several Web 2.0 startups, including the aforementioned Twitter, Scribd, and SmugMug. This is the second big failure this year for them, so Amazon’s cloud computing is definitely starting to get bit by the ‘reliability bug’. It’s worth pointing out that this is not the first time we’ve been taken with technology that operates on a cloud-like principle that blew up in our faces, as one blogger points out the linkage between Amazon in 2008 and Bell Systems’ failure in 1990.

So where do we go from here? Cloud computing is definitely becoming a huge trend for the enterprise, but not ‘prime time enough’ for something as mission-critical as clinical data. As an aside, our hosting plan is entirely under our own control and nothing is given up to an external system for reasons which are now painfully obvious. However, the most recent announcement by HP, Yahoo and Intel to launch the Cloud Computing Test Bed is proof that all is not lost when you bet on the cloud.

But the clouds will keep on rolling, and we, we’ll keep on watching (underneath an umbrella).

PS – Apparently, MobileMe hasn’t been doing so well either. So, if we ever do cloud computing in the future, we’ll have lots of mistakes to learn from.

PPS – A pair of passionate posts on Cloud Computing have been written recently by Hugh of Gapingvoid fame: they are here and here: “We’re potentially talking about a multi-trillion dollar company. Possibly the largest company to have ever existed.” He certainly sparks up the idea more than I have.

OpenClinica 2.5 Release

We are getting very near to the release version 2.5 of OpenClinica, representing a major milestone in the development of the popular open source software for electronic data capture (EDC) and clinical data management. The release contains a number of exciting improvements, including:

–    Rules engine for executing cross-field or cross-form edit checks and triggering notifications to users
–    Scoring calculations (derived values) in case report forms (CRFs)
–    New user roles for monitors and data managers
–    Improved monitoring/query management tools and discrepancy note reporting
–    Electronic signature capabilities
–    Ability to copy and edit previously created datasets
–    Improved auditing and logging capabilities
–    Simpler CRF upload
–    Improved support for CDISC ODM v1.3
–    Support for Oracle DB Backend out of the box.
–    Minor UI and application fixes from OpenClinica 2.2
–    Improved performance and scalability

Over the past 6 weeks the core development team has been putting OpenClinica through a rigorous, validated, QA and testing procedure. There are roughly another 3 weeks of documented testing ahead of us. If you would like to try the latest beta version of the application, please download it from

Thanks to everyone in the community who has contributed to this release and provided feedback during the alpha and beta periods!

As we get closer and closer to the production release of OpenClinica 2.5, stayed tuned to this space for additional updates.

Open Source in the News for Life Sciences

My schedule’s been quite busy the past few weeks and I haven’t yet been able to complete my series of posts outlined here on open source EDC topics. I promise I’ll get back to it soon. In the meantime, I’d encourage you to check out the latest issue of the Lazlo Letter and their discussion of open source software making inroads into biopharma, in electronic data capture, clinical trials management, online collaboration, and document management. I’m an avid reader of this blog and it’s great to see his perspective on open source.

In other exciting developments, Eli Lilly has made its Life Sciences Grid open source. It’s available on Sourceforge.

Why Open Source is Good for International Health Research (and Everyone Else)

A recent article titled, “Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?”, published in PLoS (Public Library of Science) proposes that “international health research organisations combine their efforts and spending power and assist with the development of systems that are open to all.” This is a bold statement with, in my opinion, solid rationale.

The authors, Greg W. Fegan and Trudie A. Lang, manage numerous clinical trials for the Kenya Medical Research Institute–Wellcome Trust Collaborative Research Programme in Kilifi, Kenya. Like many other research organizations in developing countries, their work largely focuses on finding treatments for “neglected diseases” such as malaria, hookworm, and encephalopathies. They clearly communicate the inability for proprietary eClinical software to be a widely useable solution in such settings due to costly and restrictive licensing. 

However, Fegan and Lang define the appeal of open source as something greater than financial savings (although this is a strong motivation). In addition to freedom from license fees, open source clinical trial software built with open components and open standards is more “modifiable and amenable for use with existing software already employed.” Perhaps the most significant point made is that open source can be a more powerful way to promulgate standards and better leverage the collective efforts of disparate research institutions.

Indeed, the authors also point out that the impact of a well designed and supported open source eClinical system “can be beneficial to all clinical researchers” and urge “international health research organisations to combine their efforts and spending power and assist with the development of systems that are open to all and truly fit for purpose.”

The paper closes with the following call to action:

“Research organisations and funders should combine efforts to produce an open-source solution for trial data management. A shared platform could then be easily established, and would bring wider benefits such as electronic submission to regulators, automated sharing of data, and contribution to important public databases such as pharmacovigilance and drug-monitoring registries.

We believe that an open-source approach to a truly designed-for-purpose data-management system for clinical trials is attractive. Such a system would save money by eliminating the reliance on the use of expensive database software systems and their administrators. This would empower and enable a wider variety of people to conduct trials, as the question of capturing, cleaning, and extracting data would not be overly daunting or expensive. This point is significant, as it may encourage more investigators in resource-poor settings to take part in high-standard research that would otherwise be out of reach and beyond their capacity. Surely this would increase the scope and variety of trials that are conducted. Our hope for this article is that it will begin a debate on this topic, and lead to a concerted effort to lobby the international research and donor community to make sure this barrier to trial conduct is understood and addressed.”

I encourage you to read the full article online at the PLoS website.

iPhones for Electronic Data Capture in Clinical Trials?

Could it make sense to use iPhones for electronic data capture in clinical trials? On a whim some folks at our office decided to try using OpenClinica from their iPhones. We were quite impressed with the results and found the application works very well as is from this device. See for yourself!

CDASH: A new way to standardize data elements

Many people who work with EDC systems have heard of or been impacted by CDISC, Clinical Data Interchange Standards Consortium.  CDISC’s mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.  They have many different initiatives, but one of their newest ones promises to aid the development and use of electronic Case Report Forms (eCRFs), the foundation of an EDC system.

Clinical Data Acquisition Standards Harmonization, (CDASH) aims to standardize ways of collecting data in a clinical trial.  The current EDC landscape has hundreds, even thousands, of different eCRFs that capture essentially the same information, but with CDASH’s initiative one common data element can be used for each piece of information collected.

The initiative is not being pushed to enforce the way an eCRF looks and feels; rather, it seeks to standardize the way the fields and data on a form map to a database.  Allowing users to create eCRFs with one standard in mind will allow the users to re-use their work again and again rather than having to create new eCRFs the next time they begin a study.

By mapping OpenClinica CRFs to CDASH content standards (element name, definition, and the related metadata) users of OpenClinica can access a basic set of global data collection fields with semantics agreed upon by representatives from Contract Research Organizations (CROs), Academia, Government and Industry.  These CRFs can be found in the OpenClinica Enterprise CRF Library.

Electronic Data Capture (EDC) Spending on the Rise

Health Industry Insights, an IDC Company, recently published a new forecast of the domestic market for electronic data capture (EDC) software. The report titled, “U.S. Electronic Data capture 2006-2011, Spending Forecast and Analysis,” predicts that spending on EDC solutions will total more than $3.1 billion by 2011. This represents an average annual market growth rate of about 15% between now and then.

It is interesting to consider some of the primary factors that are likely driving this trend:

  1. New products to fuel growth. As pharmaceutical companies’ blockbuster drugs run off-patent there is a dearth of candidates waiting to replace them. As a result, many of the large pharma companies will be forced to put their sizeable cash stores to work in the form of increased R&D expenditures and/or acquisitions of smaller firms. Either way, this funding should result in more clinical research. 
  2. EDC is finally a “proven” technology. While once fairly commonplace, stories of failed EDC implementations seem to have become increasingly rare. It seems that EDC is finally delivering upon its promise to enhance the productivity and ROI of clinical studies. With EDC no longer considered a bleeding-edge approach to clinical trials, the level of EDC adoption is starting to look more like an S-curve. According to IDC, “approximately half nearly half of all new Phase I-III studies are now initiated using EDC.”
  3. The globalization of clinical trials. As clinical trial sponsors are driven to control costs and speed discovery, they are partnering with CROs on an increasingly larger portion of their studies. As a result, the CRO industry has been exploding. As competition in the industry increases, these organizations increasingly look towards EDC systems to help make themselves more efficient and deliver higher quality data to the sponsor within a shorter timeframe.

There are invariably other factors driving the growth of EDC, such as the expansion of adaptive trials and increased maturity and expectance of independent standards such as those promulgated by CDISC (Clinical Data Interchange Data Standards Consortium). The intersection of these factors is creating an exciting time in the eclinical industry and 2008 promises to be a dynamic year for new developments and market changes.