Required Information for Assessing the Effectiveness of Your Minority Recruitment Efforts
- Demographics. Provide summary information showing the demographics of the primary geographic catchment area of the center by ethnic categories and subcategories and by gender , as well as for the cancer patient population treated at the cancer center.
- Accrual. Complete Parts A and B of the “Inclusion Enrollment Report Table”, found in the PHS Form (rev 06/09). Provide summary accrual information from the most recent 12-month period by ethnic categories and subcategories and by gender in the following two areas: (a) the therapeutic clinical trials conducted at the cancer center, and (b) the non-therapeutic trials conducted at the cancer center. Relate this information to the demographic information provided above.
- Deficiencies and Corrective Actions. If there are any proportional deficiencies in the accrual of women and minorities to therapeutic and non-therapeutic trials relative to the opportunities as defined by the demographics of the center’s catchment area, note:
- Any general policies of the institution designed to help with this problem
- Unavoidable circumstances that impede accrual of women and minorities (e.g., a high proportion of non-eligible patients)
- Actions planned or being taken by the center, based on careful analyses of the population, which demonstrate a clear effort to correct deficiencies that are potentially avoidable.
- In addition, the revised PHS Form 398 instructions (rev. 06/09) require applicants to provide data on the composition of proposed study populations in terms of gender and racial/ethnic groups. For CCSG applications, this requirement is limited to projected accrual to phase III studies that utilize CCSG resources and are not funded by any other PHS grant mechanism. See the PHS Form 398 (rev. 06/09) for table formats for both targeted/planned enrollment and actual enrollment. Please indicate if you have no phase III trials that meet this criterion.
Ref: NIH Revitalization Act of 1993 (Section 429B)
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