INVESTOR NEWSLETTER ISSUE N°3
A big part of our ability to hold these annual Interchanges is due to the generous support of our exhibitors and sponsors. And, for the first time ever, thanks to a sponsor, all attendees were able to get free wireless Internet access. In today’s connected world, this is a major benefit and many attendees were really appreciative of this convenience. We hope to get sponsorship for this Internet connectivity at all future Interchanges.
It was great that the registration desk was in a central location and I was able to witness first hand the interaction amongst the attendees. Be it long-time colleagues catching up or new acquaintances engaged in the the exchange of information – people were interacting. If our goal in providing these events is to create an opportunity for this type of knowledge sharing for our peers in the industry, then we definitely met and exceeded this goal. So kudos to all those who made this a success – our attendees, speakers, sponsors, exhibitors, trainers and especially the team of CDISC staff who worked behind the scenes preparing and participating in this event, to all those who cheerfully adjusted when required, and to each and every participant.
Re gulators Speak at the CDISC Europe
Interchange Dr. Rebecca Kush, CDISC President & CEO CDISC is accelerating its penetration not only with pharmaceutical organizations, but also academia and healthcare, and CDISC is front and center on the minds of our global regulators. This was a comment made by one of the speakers at the CDISC Europe Interchange, and it was borne out through presentations by representatives of regulatory authorities from Europe, Japan and the U.S.
Yuki Ando is lead for the Japan PMDA statistics group and she leads several task forces within PMDA, including the group that is responsible for the use of patient-level data (i.e. CDISC implementation). The Pharmaceuticals and Medical Devices Agency, established in 2004, is a Japanese Regulatory Authority working with the Japanese Ministry of Health, Labour and Welfare (MHLW). In FY 2013 PMDA conducted a pilot project confirming the feasibility of reviewing and analyzing data in CDISC format using actual data in clinical trials. There were 80 reviewers and 20 staff involved in this pilot. Ms. Ando’s slide stated: “Data Standards = CDISC is the key in handling the clinical study data of a lot of products at the PMDA.”
The draft Policy from PMDA will be available this summer. They will request SDTM datasets with metadata (define.xml), ADaM datasets with metadata and programs
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for generating ADaM, ADaM datasets for ISS/ISE, variables which have controlled terminology or codelists recommended by CDISC. PMDA will offer a consultation meeting for electronic data submission plans; issues should be discussed between the sponsor and the PMDA before the data submission for NDA.
In FY 2014, there will be another pilot using CDISC- compliant data. Tasks for this pilot, based upon the 2013 pilot, include improvement of compliance with CDISC, handling of Japanese characters, and an effort to make the dataset easier to understand. Ms. Ando stated that PMDA will make an effort to promote the CDISC standards, and in order to make their requests clear, PMDA will issue a series of the notices based on discussion with the industry. The PMDA mentioned that they believe conformance of the study data with CDISC standards and a greater understanding of the CDISC standards will be the key for future new drug applications.
Ms. Ando also participated in the CDISC CDASH Course taught by Shannon Labout, CDISC VP of Education. She and fellow PMDA representatives mentioned that they felt that if researchers use CDASH the data downstream in SDTM will be of higher quality.
Mary Ann Slack, CDER Office of Strategic Programs, is head of the Standards Program and also serves as expert to ICH. She spoke on the topic of eStudy Data and FDA: Where we Are. FDA receives ~786 study datasets per week, each up to 10 GB in size – and the genomics datasets are much bigger than this. Ms. Slack mentioned that they do not have data managers at FDA and, unfortunately, their reviewers spend 43% of their efforts for a review on data management alone. She emphasized that eStudy Data utilizing data standards would allow regulators to automate common assessments and support data exploration, automate loading and validation of submitted datasets and integrate data.
Ms. Slack went on to explain that the FDA has now passed the 50% mark for data with CDISC SDTM data in NDAs and she expressed satisfaction that this is going in the right direction. CDER is handling governance as a program and providing guidance (e.g. Providing Regulatory Submission in Electronic Format – Standardized Study Data). Regulatory Guidance is typically not binding; however, FDASIA allows for guidance to be binding, and this will be one of them.
Ms. Slack stated that the standards must be developed in an open, collaborative fashion, and that the CFAST initiative is one of the most important of these collaborations. She pointed out that they are very active in this, mentioning that
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