This proposal offers to further develop the Twin Tiers Community Clinical Oncology Program with the specific aims of: a) placing a minimum of 90 patients per year on clinical trials; b) strengthening existing research base relationships with ECOG, GITSG and RTOG; c) establishing mechanisms to comprehensively record information on patients not placed on protocol; d) establish mechanisms for controlled distribution of investigational agents; e) further develop a programmatic base for a cancer program that can serve future cancer control and prevention research aims of the NCI; f) involve primary care physicians in the cancer program; g) provide a stable administrative structure with significant commitments in personnel, space, and local funding; and h) implement a complete data management plan. In our Methods section, we demonstrate that the existing organizational structure and expertise available have laid the groundwork for the proposed program. Specifically we document an ongoing cancer consortium effort between the two participating institutions. We illustrate extensive existing cancer resources and facilities, including a multi-disciplinary team of oncologic investigators with extensive previous research experience. We also document the collaborative efforts of physicians at these institutions in development of patient management guidelines, an excellent educational tool which involves primary care physicians in the cancer program. We illustrate previous research experience and in detail describe the data management plan including: protocol selection procedures; patient log and non-protocol patient teaching; guidelines for physician participation; job descriptions; patient data flow; patient eligibility screening and patient entry procedures; patient research records; data entry and transcription; data review, editing; quality control and feedback; data transmission; and pharmacy and drug management. The Methods section includes research base affiliation agreements and a detailed consortium agreement.
| Enck, R E; Boselli, B; Rosencrans, H et al. (1986) The Twin Tiers Community Clinical Oncology Program (TTCCOP) experience: the first year. Prog Clin Biol Res 216:417-22 |
