Gynecologic oncology group strategies to improve timeliness of publication.

BACKGROUND: The Gynecologic Oncology Group (GOG) is a multi-institution cooperative group funded by the National Cancer Institute to conduct clinical trials encompassing clinical and basic scientific research in gynecologic malignancies. These results are disseminated via publication in peer-reviewed journals. This process requires collaboration of numerous investigators located in diverse cancer research centers. Coordination of manuscript development is positioned within the Statistical and Data Center (SDC), thus allowing the SDC personnel to manage the process and refine strategies to promote earlier dissemination of results. A major initiative to improve timeliness utilizing the assignment, monitoring, and enforcement of deadlines for each phase of manuscript development is the focus of this investigation. PURPOSE: Document improvement in timeliness via comparison of deadline compliance and time to journal submission due to expanded administrative and technologic initiatives implemented in 2006. METHODS: Major steps in the publication process include generation of first draft by the First Author and submission to SDC, Co-author review, editorial review by Publications Subcommittee, response to journal critique, and revision. Associated with each step are responsibilities of First Author to write or revise, collaborating Biostatistician to perform analysis and interpretation, and assigned SDC Clinical Trials Editorial Associate to format/revise according to journal requirements. Upon the initiation of each step, a deadline for completion is assigned. In order to improve efficiency, a publications database was developed to track potential steps in manuscript development that enables the SDC Director of Administration and the Publications Subcommittee Chair to assign, monitor, and enforce deadlines. They, in turn, report progress to Group Leadership through the Operations Committee. The success of the strategies utilized to improve the GOG publication process was assessed by comparing the timeliness of each potential step in the development of primary Phase II manuscripts during 2003-2006 versus 2007-2010. RESULTS: Improvement was noted in 10 of 11 identified steps resulting in a cumulative average improvement of 240 days from notification of data maturity to First Author through first submission to a journal. Moreover, the average time to journal acceptance has improved by an average of 346 days. LIMITATIONS: The investigation is based on only Phase II trials to ensure comparability of manuscript complexity. Nonetheless, the procedures employed are applicable to the development of any clinical trials manuscript. CONCLUSIONS: The assignment, monitoring, and enforcement of deadlines for all stages of manuscript development have resulted in increased efficiency and timeliness. The positioning and support of manuscript development within the SDC provide a valuable resource to authors in meeting assigned deadlines, accomplishing peer review, and complying with journal requirements.

Gynecologic Oncology Group quality assurance audits: analysis and initiatives for improvement.

BACKGROUND: The Gynecologic Oncology Group (GOG) is a multi-institution, multi-discipline Cooperative Group funded by the National Cancer Institute (NCI) to conduct clinical trials which investigate the treatment, prevention, control, quality of survivorship, and translational science of gynecologic malignancies. In 1982, the NCI initiated a program of on-site quality assurance audits of participating institutions. Each is required to be audited at least once every 3 years. In GOG, the audit mandate is the responsibility of the GOG Quality Assurance Audit Committee and it is centralized in the Statistical and Data Center (SDC). Each component (Regulatory, Investigational Drug Pharmacy, Patient Case Review) is classified as Acceptable, Acceptable, follow-up required, or Unacceptable. PURPOSE: To determine frequently occurring deviations and develop focused innovative solutions to address them. METHODS: A database was created to examine the deviations noted at the most recent audit conducted at 57 GOG parent institutions during 2004-2007. Cumulatively, this involved 687 patients and 306 protocols. RESULTS: The results documented commendable performance: Regulatory (39 Acceptable, 17 Acceptable, follow-up, 1 Unacceptable); Pharmacy (41 Acceptable, 3 Acceptable, follow-up, 1 Unacceptable, 12 N/A): Patient Case Review (31 Acceptable, 22 Acceptable, follow-up, 4 Unacceptable). The nature of major and lesser deviations was analyzed to create and enhance initiatives for improvement of the quality of clinical research. As a result, Group-wide proactive initiatives were undertaken, audit training sessions have emphasized recurring issues, and GOG Data Management Subcommittee agendas have provided targeted instruction and training. LIMITATIONS: The analysis was based upon parent institutions only; affiliate institutions and Community Clinical Oncology Program participants were not included, although it is assumed their areas of difficulty are similar. CONCLUSIONS: The coordination of the GOG Quality Assurance Audit program in the SDC has improved data quality by enhancing our ability to identify frequently occurring deviations and develop innovative solutions to avoid or minimize their occurrence in the future.