Freedom of Information Act Office
IC Directors' Meeting Highlights
August 28, 2008
|From:||Director, Executive Secretariat|
|Subject:||IC Directors Meeting Highlights—July 10, 2008|
I. Implementation of the Food and Drug Administration Amendments Act (FDAAA), Title VIII: Expanded Clinical Trial Registry Data Bank, Dr. Deborah Zarin, National Library of Medicine (NLM)
In reference to the new law, Dr. Lindberg, Director of NLM, encouraged NIH-wide efforts to update trials data and to test and modify the new results reporting system and emphasized Institute and Center (IC) commitment for accurate and complete data entry.
Dr. Zarin explained that the FDAAA Title VIII expanded Clinical Trial Registry Data Bank new provisions require additional information to be submitted to the clinical trials data bank (www.ClinicalTrials.gov). The data bank, previously established by the NIH/NLM, includes information on clinical trials and results. The new registration requirements went into effect on December 26, 2007. In general, non-phase 1 trials of drugs, biologics or devices subject to FDA regulation must be registered if they are ongoing or started after September 27, 2007. Registration requirements include twenty-five data elements listed in law (many previously optional in ClinicalTrials.gov).
Dr. Zarin reported that NLM has accomplished the following:
- Convened a NLM Board of Regents Working Group on clinical trials;
- Expanded ClinicalTrials.gov Registry:
- System modified to accept additional data elements;
- Links established from registry to NIH/NLM and FDA results information;
- Preliminary information developed for affected communities.
- Developed “Basic Results” Database:
- Mock-up of data entry system posted for public comment, announced via Federal Register;
- Consultations with external experts, stakeholders.
- Briefed NIH ICs and several NIH committees.
Immediate actions for NIH include registering all trials and all data elements for NIH-funded clinical trials, and individual ICs to complete entries and continue to work with the Office of Extramural Research (OER), the Office of General Council (OGC) to develop appropriate models for IC assistance to grantees (for registration and results). In addition, the FDAAA Implementation Team will set up a process to develop NIH policy regarding selection of “responsible party” when NIH is sole or joint “sponsor,” and continue to develop a Communication Plan with the NIH Office of Communications and Public Liaison (OCPL).
Dr. Zarin explained that the “Basic Results” reporting requirements include:
Trials of FDA-approved/cleared drugs, biologics and devices required information:
- Demographic and baseline characteristics (by arm);
- Primary and secondary outcomes (by arm);
- Point of contact (for scientific information);
- Certain agreements (restrictions on PI to discuss or publish results after trial completion date).
Deadline for submitting information:
- Within 12 months of “completion date;”
- Delayed submission if certify seeking new use.
- Adverse event information to be added later (18-24 months).
Dr. Zarin encouraged ICs which support trials, to provide feedback on iterative changes and prepare for results submission. NLM will implement a results reporting system by Sept 27, 2008. The FDAAA Implementation Team will develop a process for agreeing on minimum results reporting requirements.
IC Directors discussed enforcement and compliance issues of the new law and agreed with timely compliance and complete and accurate data entry.
II. Scientific Presentation: Characterization of Human Epigenomes, Dr. Keji Zhao National Heart, Lung and Blood Institute (NHLBI)
Dr. Nabel, Director NHLBI, introduced Dr. Zhao, who is working on NIH Intramural research on the characterization of human epigenomes. Dr. Zhao presented his research findings. He explained epigenomes are chromatin modifications including both DNA methylation and various histone modifications as well as small RNA expression patterns. He stressed that scientists study epigenomes because chromatin modifications are implicated in regulating various processes including transcription, replication and genome stability, and that alteration of chromatin structure has been linked to many diseases.
Cc: OD Small Staff