The next BACDISC Network meeting is being planned for early November. Due to COVID, meetings going forward will be done as a series of shorter 90-minute virtual meetings instead of the half-day in-person meetings we’ve done in the past. Part of each virtual meeting will be devoted to a timely industry or FDA topic while the other part will be a specifically CDISC-focused topic. We’ll send out a notification this month asking users to respond to a survey of potential topics in which you can vote for your first, second and third choices among the topics below, and suggest other topics you want to hear about. Also let us know if you’d like to be a presenter or participate in a panel discussion!
Here are some candidates for the industry/FDA topics:
- Impact of COVID-19 on the planning, conduct, data collection, analysis, documentation and submission of clinical trials. To date, the FDA has issued 53 Guidances related to COVID-19, and circumstances have affected the planning and conduct of studies for most, if not all, pharma companies. This seems like a good topic for a panel discussion. If you’re interested in participating, please indicate that when you vote in the survey.
- Update on FDA’s implementation of the new Technical Rejection Criteria. Agreement has been reached about how these will be implemented. The agency will give 90 days’ notice before taking action, which is expected within the next few months. This change affects everyone who contributes to eCTD modules 4 and 5 – Nonclinical, Clinical, Biometrics, Regulatory, Regulatory Publishing. For the first time, these new rules require specific content in SDTM and ADaM datasets, and in define.xml. Failing to provide that content in even one study can result in the rejection of the entire submission. We’ll provide details on how to satisfy the rejection criteria.
- WHODrug coding in the B3 format. This version of WHODrug has become a de facto requirement, as the Uppsala Monitoring Centre (the WHODrug standards organization) has stopped supporting the B2 format that we’ve all been using for the past 40 years. This has big implications for how we model CM data in SDTM and ADaM, and how we format ConMed tables for study reports. This data can be represented several ways, including potentially 280+ supplemental qualifiers or comments, or a whole separate domain devoted to the possible coding variants. In tables, we’ll have to deal with preferred terms that can be up to 1,200 characters long, which is most of a page when put in a 2-inch wide column. How will the FDA use this data? What format would they prefer to see in submissions? We’ll try to bring that information to the meeting.
- The ADaM team has put together recommendations for structuring integrated ADaM databases for ISS and ISE analyses. This is a big step forward, as it is not intuitively obvious how to deal with some of the pooling issues in ADSL, and the most workable solutions trigger a barrage of Pinnacle21 diagnostics. Anyone working on an integrated analysis of safety or efficacy needs to know these recommendations.
- FDA’s Preferences for SEND data and documentation. Remember in 2011 when the agency decided how it wanted SDTM to be submitted, then a couple years later published their own validation criteria that were incorporated in the OpenCDISC validator? What the agency is dealing with now in SEND is similar to what they tried to fix in SDTM back then. They hosted a webinar on June 15 to communicate their SEND preferences, describe the issues they’re seeing, and the difficulties they create for review of submissions. We’ll provide a summary of their action items.
We're still working on the list of CDISC-specific topics. We'll post them here when the survey is ready.