Table 1. Characteristics of Voting Members at All Meetingsa With at Least 1 Section 502 Conflict, 2008-2014.
Characteristic | Members With Conflicts, No. (%) | P Value | |||
---|---|---|---|---|---|
Section 502 Only (n = 187) |
Section 208 Only (n = 12) |
Both (n = 14) |
Neither (n = 1269) |
||
Committee member status | .73b | ||||
Standing | 75 (40.1) | 3 (25.0) | 5 (35.7) | 513 (40.4) | |
Temporary | 112 (59.9) | 9 (75.0) | 9 (64.3) | 756 (59.6) | |
Participant’s role in the affected organization | .56c | ||||
Principal investigator | 39 (20.9) | 3 (25.0) | NA | NA | |
Officerd | 69 (36.9) | 4 (33.3) | NA | NA | |
Consultant-speaker | 44 (23.5) | 1 (8.3) | NA | NA | |
Employee | 14 (7.5) | 1 (8.3) | NA | NA | |
Others | 21 (11.2) | 0 | NA | NA | |
Stakeholders | 0 | 3 (25.0) | NA | NA | |
Source of conflict | <.001c | ||||
Sponsor | 167 (89.3) | 5 (41.7) | NA | NA | |
Competitor | 16 (8.6) | 7 (58.3) | NA | NA | |
Both | 4 (2.1) | 0 | NA | NA | |
Nature of conflict | .53c | ||||
Imputede | 114 (61.0) | 8 (66.7) | NA | NA | |
Personal | 55 (29.4) | 4 (33.3) | NA | NA | |
Both | 18 (9.6) | 0 | NA | NA |
Abbreviation: NA, not applicable.
Includes product and nonproduct meetings at the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health. Individual advisory committee members may have attended more than one meeting. The 502 conflicts are identified only if no section 208 conflict exists for a particular meeting. Individuals may have waivers for both conflicts if they are issued for different particular matters.
Pearson χ2 test, comparing all 4 categories.
Pearson χ2 test, comparing only section 502 conflict with only section 208 conflict.
A person elected or appointed to manage the organization’s daily operations, such as a president, vice president, secretary, treasurer, or board chair.
Conflicts assigned to an advisory committee member based on their personal relationships or employment (eg, a research contract with a potential members’ employer in which the member has no involvement).