PubMed · 12750567
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Webster K Cavenee. Preparing for serendipity.. https://doi.org/10.4161/cbt.2.2.254
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BACKGROUND: Since 1987, cancer centers and clinical cooperative groups serving as 'research bases' for the National Cancer Institute's (NCI) Community Clinical Oncology Program (CCOP) have been required to design and conduct cancer prevention and control (CP/C) clinical trials in addition to therapeutic trials. The study describes the structural and strategic adaptations that CCOP research bases have made to incorporate CP/C research into their scientific agendas and operations. METHODS: Approaches to CP/C research in four cooperative groups with different scientific agendas were investigated: the Eastern Cooperative Oncology Group, the National Surgical Adjuvant Breast and Bowel Project, the North Central Cancer Treatment Group, and the Southwest Oncology Group. Sixty-five individual interviews with group leaders and investigators were conducted. Data were coded and thematically analyzed from transcribed interviews, observations of scientific sessions, and secondary documents. RESULTS: The cooperative groups have tailored CP/C research programs to fit the interests, skills, and practice settings of their investigators without making significant adaptations in administrative and statistical infrastructures. Ongoing challenges include finding ways to broaden the pool of investigators designing CP/C protocols, involve more nononcologists in protocol design, and secure more stable and adequate funding for CP/C research. CONCLUSION: The cooperative groups' experiences with CP/C research suggest that, with adequate resource investments, existing clinical research networks can expand into new areas of scientific investigation.
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Recently, paradigm shift from expert opinion towards evidence-based medicine has occurred encouraging physicians to base their treatment decisions on the best available research evidence. In the hierarchy of evidence randomized clinical trials (level 1 evidence) are considered of the highest quality (least biased) while non-randomized studies represent lower levels (levels 2-4). Several pitfalls in the design and conduct of clinical research include: lack of randomization, lack of concealment, lack of blinding, and errors in hypothesis testing (type I and II errors). A basic understanding of these principles of research will empower both investigators and readers when applying the results of research to clinical practice.