Standards from the Start - CDISC in 2010
January 28, 2010
As always, CDISC begins the year with a flurry of activity (do keep an eye on the website for regular updates and news on the standards). In addition to the CDISC standards themselves, the CDISC Board and Operations Staff also spent the last quarter of the year reviewing the CDISC Strategy and make appropriate changes (see the new CDISC Strategy 2010). This led to the development of a set of ‘key drivers' based upon the Strategy and create the environment to set goals for the New Year. These include technical standards development as well as Communications, Collaborations and Financial aspects for CDISC.
The 2010 goals will be posted later this year due to an excellent opportunity to ensure that they are aligned with those of FDA CDER and CBER. In November and December 2009, FDA representatives met with the CDISC Board and Operations leaders; others from FDA participated in the CDISC Interchange. Consequently, a key meeting with the CDISC Executive Committee and FDA representatives is scheduled for early February. We will be reporting more about this opportunity and the outcome of our coming discussions in future eNewsletters. In the interim, we already know some of the key drivers for 2010 and would like to outline those for you now.
Focus Area for CDISC 2010:
This year, as a focus area, CDISC wants to encourage all organisations and their partners to adopt the CDISC standards at the "front end" of the medical research process i.e.-when a programme or study is being designed, "Use Standards from the Start". Why? Well it's simple, by using standards from the start, you can gain the greatest benefits in terms of the time and cost savings and reap the highest quality data, an extremely valuable asset. Understandably, adoption of the Submission Data Standards has been the focus for many companies. However, CDISC now has a complete suite of standards that can be used right from the development of the protocol. Therefore, it seems sensible to collect standards the way we want to submit them, thus avoiding costly, time-consuming (and sometimes difficult mapping exercises) to do data conversions at the end of the process, prior to submission, when companies should be focusing on the science of their research.
With this in mind, below are current key drivers influencing the goals for CDISC in 2010:
Drive adoption of and support new and existing standards (through technical, communications and education support) by emphasizing implementation at the ‘front end' of the process (build in quality to reap the greatest benefits)
CDASH for case report forms as a path to reporting and submission
Protocol Representation for trial registration and study design
Retrieve Form for Data Capture (RFD) IHE Integration Profile (to capture data directly from electronic health records) and implementation of the HITSP Clinical Research Interoperability SpecificationSupport
FDA needs for standards now:
New efficacy standards development
Refinement of SDTM (especially instructions for use)
Enable SHARE as a key goal of the CDISC Technical Roadmap
Bind healthcare link with core CDISC standards development and support; integrate healthcare link roadmap with CDISC technical roadmap (same as 2009) and launch healthcare link opportunities
Bring BRIDG to a global standard
Continue collaboration development and management on a global basis
Identify new funding opportunities and manage operational tasks to the budget on a regular basis
As indicated previously, CDISC is working closely with the FDA representatives to address their current needs and in the coming weeks, we will be updating the overall CDISC Goals for 2010 to reflect those discussions. The 2010 Goals will be posted on the website thereafter.
In 2010, CDISC will continue to represent your views and thoughts on a global basis in collaboration with a number of organizations. Over the next month, we will be developing a page for the website that will outline the organizations where your voice is being represented via CDISC and the value that is brought to you through your CDISC membership. These connections are vital to ensure that CDISC remains aligned with global developments, and they also ensure that the standards are being adopted as widely as possible. We'll announce when the page goes live and you may be surprised at the number of organizations where you are represented.
CDISC Communications continues to develop strategies to ensure all of you are receiving our messages; this year, in particular, we would like to hear more about your views on our digital strategy. In 2009, we launched the CDISC Primer to give everyone an overview of how the standards fit together, how to implement standards, the business case for standards and more. We launched a Twitter account, in order to microblog our activities and we recommend you follow this if you are not already doing so. Perhaps our major achievement last year was the launch of the new CDISC website, which has proved to be a popular move, judging by the number of hits we are getting and the great feedback we have received. The CDISC blog now resides on the CDISC website and has regular updates from our technical teams and communications on our activities.
So what next for CDISC Communications? In 2010 we plan to launch the CDISC journal, where we would like to encourage you to write articles or case studies about your implementation experiences. In the next few months, we will be asking you to submit articles for our first issue, which will be published to coincide with the CDISC Interchange in North America in October. We want all our community to share ideas and successes to support adoption and to help others just starting out on the standards road to implement successfully.
Finally, in 2010, please be sure you continue to support CDISC through membership. Whilst we keep our standards open and accessible to everyone, we need your membership to ensure that they continue to be supported and promoted on a global stage. We are grateful to those companies who have shown us continuous support and those individuals who give up valuable time and effort to ensure that we have an efficient and truly collaborative development process. 2010 will be as busy as ever and we look forward to you joining us on the journey.
AJ de Montjoie