Notes from the Aug 22, 2011 Meeting of the IOM Committee on the Use of OMICS-Based Markers in Clinical Trials

This web page is designed to hold files from the Aug 22, 2011 meeting of the IOM Committee examining the use of Omics-based signatures in clinical trials. Some case studies related to the formation of this committee are presented in the manuscript Deriving Chemosensitivity from Cell Lines: Forensic Bioinformatics and Reproducible Research in High-Throughput Biology by Keith A. Baggerly and Kevin R. Coombes (the main page is here) and Subsequent Reports (available here).

Session Description and Agenda

The day-long Aug 22 meeting of the IOM Omics committee was entirely devoted to feedback from Duke University faculty and leadership concerning institutional responses to the problems encountered. The official agenda is available here. The meeting was organized by the committee's Discovery of Process Working Group (DPWG), headed by Tom Fleming, and was broadly organized as follows:

Introduction of Committee and Duke Initial Remarks
1. Large Topics
2. Oversight
3. Conflict of Interest
4. Duke's External Review
5. Data Provenance
6. Quantitative Expertise
Wrapup and Suggestions for the Committee

No written documents were provided, but roughly 8.5 hrs of testimony were recorded.

MP3 Files of Topic Presentations

MP3 files from Aug 22 are given below in chronological order. Unlike earlier meetings, these files do not correspond to presentations by specific individuals. Rather, they are grouped by the topic being addressed, with questions being posed by the committee and answered by the Duke representatives as an ensemble. Brief descriptions of the 15 distinct MP3 files are given below.

1. Part 01, 08:00-08:40 (41 min, 25 sec; 19.9 Mb).
Session introduction, personal introductions, outline of day's topics, Duke introductory statement by Rob Califf, initial "Large Topic" questions and answers.
2. Part 02, 08:40-09:10 (30 min, 59 sec; 14.9 Mb).
Further "Large Topic" questions and answers.
3. Part 03, 09:10-09:55 (47 min, 46 sec; 22.9 Mb).
Oversight of Clinical Research.

Morning Break

4. Part 04, 10:15-11:30 (1 hr, 12 min, 25 sec; 34.8 Mb).
Oversight of Clinical Research and the IRB.
5. Part 05, 11:30-12:30 (55 min, 51 sec; 26.8 Mb).
Classifier lockdown, FDA guidance. Conflict of Interest (COI) in the clinical trials.
6. Part 06, 12:30 (33 sec; 0.3 Mb). Adjourn for lunch.

Lunch Break

7. Part 07, 13:00-13:30 (27 min, 6 sec; 13.0 Mb).
Followup questions re COI.
8. Part 08, 13:30-14:30 (1 hr, 2 min, 19 sec; 29.9 Mb).
Duke's External Review.
9. Part 09, 14:30-14:37 (7 min, 17 sec; 3.5 Mb).
Clarification of Bill Barry's role in Duke's External Review.

Afternoon Break 1

10. Part 10, 14:45-15:00 (12 min, 5 sec; 5.8 Mb).
Followup question on institutional COI; university patent ownership.
11. Part 11, 15:00-15:40 (40 min, 30 sec; 19.4 Mb).
Data provenance; storage of clinical data.
12. Part 12, 15:40-16:20 (39 min, 33 sec; 19.0 Mb).
Quantitative expertise; establishing statistical collaborations and the statistician's role.
13. Part 13, 16:20-16:35 (15 min, 52 sec; 7.3 Mb).
Nonrandom labeling, status of Potti manuscripts, Bill Barry's review of the cisplatin predictor.

Afternoon Break 2

14. Part 14, 16:40-17:35 (56 min, 24 sec; 27.1 Mb).
Identification of responsible parties. Challenges encountered by the Duke presenters, and suggestions they have for the IOM committee.
15. Part 15, 17:35-17:40 (2 min, 46 sec; 1.3 Mb).
Thanks to presenters and organizers.