III. Phase IV - post license safety and surveillance of drug, vaccine,
or nutritional therapies
NCCC has been or would consider being involved in the following:
1. Enrolling and tracking patients over long periods of time and across diverse geographic locations using both web-based and hard copy tracking methods
2. Identification of promising locations for trials through analysis of public cancer registry data
3. Internal identification of physicians that may have patients eligible for a trial
4. Directly working with physicians to enroll patients and retain them in the trial
5. Rapid case ascertainment of cancer patients - population-based participant identification within months of diagnosis*
6. Recruitment of underserved populations, such as Vietnamese, Chinese, Hispanic, and other groups
7. Data collection instrument development and validation (both hard-copy and web-based)
8. Processing of data: data cleanup, traceability and auditability of data contained in the case report form (CRF); ensuring databases reflect clean CRFs
9. Development of statistical plans and conduct of statistical analysis
10. Preparation of reports to conform to FDA or other regulatory agency guidelines
11. Receiving, tracking, reviewing and processing adverse events; creating and tracking safety case files
12. Monitoring risk and adjusting risk models as evidence accumulates
13. Developing patient or health provider educational materials using culturally sensitive and appropriate language and symbols
14. Providing toll-free follow-up services for patients
15. Centralized IRB review
* We have the ability to select patients based upon a number of criteria such as: clinical or pathology-based disease characteristics, race/ethnicity, area of residence, age, gender, residence in disadvantaged census tracts, type of treating facility, etc. It is also possible to either include patients from a broad geographic area or restrict patients to those living in the Greater Bay Area. Disease definition and patient inclusion criteria will dictate the size of the geographic area that can be covered.
Back to Guide for Collaborators home page.
NCCC conducts innovative and dynamic cancer research and outreach programs that explore areas with significant impact on reducing the cancer burden. For more information about our research programs or possible collaborations, contact Tim Radak (tradak@nccc.org, 510-608-5026) or Ingrid Oakley-Girvan (ioakley@nccc.org, 510-608-5045).
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