February 27, 2008
IC Directors
Kerry Brink, Assistant to the Deputy Director, NIH
IC Directors’ Meeting Highlights – January 24, 2008

Discussion Items

I. Adverse Event Reporting, Dr. Lana Skirboll, Director, Office of Science Policy (OSP), Dr. Amy Patterson, OSP

The NIH chairs the Federal Adverse Event Task Force (FAET), which charge is to propose specific means for promoting harmonized and streamlined federal requirements for reporting, analyzing, and communicating adverse events in clinical research. Dr. Skirboll explained while considerable effort is put into collecting safety data, finding actual safety signals is a challenge because of information overload, poor pattern detection, mismatch between tools and knowledge of disease mechanisms, and lack of standards impacting data completeness, quality and analysis. The effort to harmonize and streamline adverse event reporting is the number one priority for re-engineering the clinical research enterprise.

The FAET is comprised of several federal agencies and the goals and objectives of the FAET are as follows:

  • Agencies to speak the same language;
  • Reduce variability in terms and definitions;
    • Align federal adverse event reporting policies;
  • Develop a best practices blueprint for reporting, analysis, and application of safety information;
  • Produce one core adverse event report that Principal Investigators (PIs) can send to multiple agencies;
    • Develop the Basal Adverse Event Report (BAER)
      • A single set of core medical information acceptable to multiple agencies and containing information needed for adverse event and unanticipated problem reporting across all types of clinical research (behavioral, social sciences, epidemiologic, etc.).

Under a Memorandum of Understanding, the NIH and Food and Drug Administration (FDA) are unifying approaches to adverse event reporting by developing a user-friendly electronic submission system to report an adverse event to the NIH, FDA, and other government agencies. Dr. Skirboll stressed that establishing a standardized adverse event data collection system across government as a central web-based portal will facilitate and streamline submission of pre and post-market adverse events, improve data quality, and analysis and provide ‘one stop shopping’ for investigators.

IC Directors agreed there are many benefits of harmonizing and streamlining adverse event reporting including reducing costs of duplicative reporting systems and potentially improving the conduct of clinical trials.

II. Update on the Biomarkers Consortium, Dr. John Niederhuber, Director, National Cancer Institute (NCI)

Dr. Niederhuber explained that the Biomarkers Consortium was established to develop promising biomarkers for research, clinical, and/or regulatory uses.  The Consortium’s objectives are to clinically validate the use of biomarkers for specific diseases and their treatment, inform regulatory metrics for evaluating biomarker efficacy, and promote dialogue across sectors to increase understanding of each other’s biomarker priorities. 

The three stages of biomarker development consist of:

  1. Discovery stage - explores innovative ways to measure response to be used in early disease detection and to be used in quantifying response to therapy;
  2. Middle stage - monitors natural course of disease to identify significant endpoints;
  3. Late stage - validates biomarkers as endpoint surrogates for regulatory review, research and clinical use.

Current contributing members of the Biomarkers Consortium comprise representatives from 22 for-profit companies and 29 non-profit organizations.  These entities supply resources for infrastructure and project support and can also provide, as the NIH does, resources in kind, such as data and intellectual guidance.  Data and materials generated by a project must be made publicly available. 

All founding partners, including NIH, FDA and Industry members, must agree on each project before it goes forward.  An Executive Committee, comprised of representatives from key constituent groups, serves as the chief decision-making body approving project concepts based on scientific, clinical and regulatory importance and also, stimulates ideas for new projects.  Representing the NIH, Drs. Niederhuber (NCI), Insel (NIMH) and Tabak (NIDCR) are members of the Executive Committee.  The Executive Committee approves the Steering Committee (SC) membership.  The SCs deliberate on development of ideas in specific disease areas, developing detailed project implementation plans, subgroups or project teams and enlisting ad hoc experts to provide expertise.  Current SCs are focused in the areas of cancer, inflammation and immunity, metabolic disorders and neuroscience. 

New activities of the  Biomarkers Consortium are to identify “high profile” projects.  Solicitation will be sent within the next couple of weeks.  Dr. Niederhuber requested that IC Directors contribute ideas for biomarker projects, and recommend members for the Steering Committees and project teams.   IC Directors endorsed the Biomarkers Consortium as an essential catalyst in promoting new ideas and effort from the scientific community and the public.

Kerry Brink
cc: OD Senior Staff

This page was last reviewed on May 8, 2008 .
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