Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400.

The Lung Master Protocol (Lung-MAP, S1400) is a groundbreaking clinical trial designed to advance the efficient development of targeted therapies for squamous cell carcinoma (SCC) of the lung. There are no approved targeted therapies specific to advanced lung SCC, although The Cancer Genome Atlas project and similar studies have detected a significant number of somatic gene mutations/amplifications in lung SCC, some of which are targetable by investigational agents. However, the frequency of these changes is low (5%-20%), making recruitment and study conduct challenging in the traditional clinical trial setting. Here, we describe our approach to development of a biomarker-driven phase II/II multisubstudy "Master Protocol," using a common platform (next-generation DNA sequencing) to identify actionable molecular abnormalities, followed by randomization to the relevant targeted therapy versus standard of care.

Participatory design of a collaborative clinical trial protocol writing system.

OBJECTIVE: To explore concrete approaches to socio-technical design of collaborative healthcare information systems and to design a groupware technology for collaborative clinical trial protocol writing. METHOD: We conducted "quick and dirty ethnography" through semi-structured interviews, observational studies, and work artifacts analysis to understand the group work for protocol development. We used participatory design through evolutionary prototyping to explore the feature space of a collaborative writing system. Our design strategies include role-based user advocacy, formative evaluation, and change management. RESULTS: Quick and dirty ethnography helped us efficiently understand relevant work practice, and participatory design helped us engage users into design and bring out their tacit work knowledge. Our approach that intertwined both techniques helped achieve a "work-informed and user-oriented" design. This research leads to a collaborative writing system that supports in situ communication, group awareness, and effective work progress tracking. The usability evaluation results have been satisfactory. The system design is being transferred to an organizational tool for daily use.

Cancer research training: the Southwest Oncology Group young investigator training program (YITP).

BACKGROUND: Recognizing the growing need for an infusion of new investigators into the cancer researchers, and realizing that well-trained cancer researchers are a dying breed, the Southwest Oncology Group (SWOG) initiated the Young Investigator Training Program (YITP) in 1999, supported by the Hope Foundation. The first author was one of four applicants accepted in 2004 and is reporting on this experience. METHODS: After a rigorous and competitive application process, four physicians beginning their career in Hematology-Oncology are chosen each year. Each investigator would have submitted an original research concept. Each class receives intensive training in statistical principles, data collection and analysis, critical decision making, and protocol development guidelines. Each investigator spends 4 days at the SWOG operations office in San Antonio, Texas, and 4 days at the statistical center in Seattle, Washington. RESULTS: As part of the training course, each investigator will design a clinical protocol that will be reviewed by the appropriate disease committees within SWOG. Once approved, it will be submitted to the National Cancer Institute for further review. The four investigators will receive a certificate at the successful completion of the training course and will be recognized at the group meeting. With the class of 2004, 31 investigators will have joined the ranks of seasoned researchers. Fifteen protocols have been introduced and activated at institutions across the United States. Four other protocols are in various stages of the development and approval process. CONCLUSION: The Hope Foundation sponsored SWOG YITP is a unique opportunity. It allows participants to acquire a thorough understanding of the conduct of cancer clinical trials through SWOG. Large institutions are urged to continue sponsoring similar programs. This will build an infrastructure of well-trained cancer researchers to foster and continue the progress achieved in cancer research.