The CDISC INTRAchange was launched this year on the evening of 23 March, following the DIA FDA CDER/CBER Computational Science Annual Conference, with a CDISC FDA Town Hall Meeting. Frank Newby welcomed everyone and introduced the FDA representatives. At the front of the room on the panel were Dr. Theresa Mullin, Director of Planning and Informatics, FDA/CDER; Dr. Charles Cooper, Medical Officer, Office of Translational Sciences, FDA/CDER; and Amy Malla, Review Management, Office of the Director, FDA/CBER. Other FDA representatives were in the audience and made comments throughout the Q & A.
To open the meeting, Dr. Mullin presented her slides on the FDA CDER/CSC Standards Implementation Plan from the Computational Sciences meeting. She stated that she has been charged by Dr. Woodcock to ‘modernize CDER’ and this is ‘foundational’. Amy Malla added that CBER is also developing a similar plan, modeled after what CDER has done, with the same concepts but different in the sense that the CBER structure is quite different from that of CDER. In addition, they will be working with CDRH (Devices) since CBER and CDRH share those reviews. Dr. Cooper stated that things are changing within CDER. It is going to take a lot of work, but they are stepping up their activity, and he acknowledged the hard work of all of the people who have contributed to CDISC. They want to ensure that reviewers see the value in standards.
These introductory remarks were followed by a lengthy Q & A from the ~ 75 attendees. Highlights from FDA participants follow. (A more complete set of notes will be available in the Members’ Area of the CDISC website.)
Dr. Mullin stated that one of her jobs is to do ‘internal marketing’ so that those in the Agency see the business proposition. This is an enabler to what we need to get done. It is the only way we are going to come into the 20th century—we need data standards. This needs to be explained to CEOs within your companies, also.
Dr. Cooper stated that they want to create documents to use in the various review divisions to share with sponsors to ensure that the points that should be made about standards are built into the review cycle early on, NOT at the NDA/BLA meeting. [Note that this was also a message from Dr. Mullin’s slide presentation.] If sponsors have questions, they should not hesitate to send e-mails to FDA (addresses were provided). In such meetings, they should ask that an OBI (formerly OBPS) representative be present.
An OBI representative stated that it is difficult to tell which submissions are done using CDISC, so the FDA cannot provide a count. Some will say they have used CDISC standards, but they have not really followed the standard. Some may use only the two letter identifiers that are from CDISC SDTM. “Plead with your management. We need CDISC! You need to commit to follow CDISC.”
The closing statement in response to a question from Wayne Kubick, CDISC Board Member, about where CDISC should focus its resources was:
“Our priorities are to work with the CDISC suite. We may need to go back to the ODM piloting that we were doing. Lots of work needs to be done, working with what is more mature. We serve the reviewers. We need to serve our review community and that is what you (CDISC) provide to us. They need to be able to see the SDTM and ADaM views – the CDISC view. All of us want to work on CDISC standards. We cannot expect you to invest in this if you cannot trust what you are hearing from FDA.”
CDISC now has a complete suite of standards---from protocol through analysis and reporting. Using CDASH for data collection (eCRFs) can save significant time and resources, both during the start of the study and at the end when preparing an eSubmission. You can view Dr. Mullin’s slides and my presentation from the FDA Computational Science Annual meeting “Planning the Clinical Research Program with your Submission in Mind” along with an excellent presentation by Dr. Frank Rockhold (Senior Vice President, Global Clinical Safety and Pharmacovigiliance, GlaxoSmithKline) on “Data Stewardship and the Art and Science of Explaining Standards So that Everyone Gets It” (including management) in the CDISC Members’ Area of the website (FDA CDISC Meetings).
