Copy of 2003 Group Newsletter 12 15 - SWOG

More documents

Recommendations

Info

Page 2 THE GROUP NEWSLETTER Message from the Chairman (Continued from front page) Bill Brown was the chairman of the committee and head of the Department of Biostatistics at Stanford University. Stephen George was the head of Biostatistics at St. Jude’s Hospital in Memphis, Tennessee. Carol Redmond was the biostatistician for the National Surgical Adjuvant Breast and Bowel Project. Professor Gio Wiederhold and Marcello Pagano were computer scientists, and Drs. Robert Freidman and Herman Mitchell were data management experts. Tom Davis and Dick Gams rounded out the team of 10 charged with reviewing the applications. A total of 10 letters of intent, followed by five full-blown applications were received. Following a detailed conference call, the five institutions were narrowed down to Johns Hopkins University and the Fred Hutchinson Cancer Research Center. These two centers were invited to a reverse site visit at the AMFAC Hotel at the Dallas- Fort Worth Airport. That reverse site visit was held December 19-20, 1984. As it turned out, neither of the applicants was approved. At the end of this 14-month process, the unacceptable or disapproval outcome of both institutions prompted an embargo of the Special Review Committee until a more appropriate outcome was reached. The Special Review Committee identified four requirements which would make the Fred Hutchinson Cancer Research Center application more acceptable. January 25, 1985, following a review of the revised application from the Fred Hutichinson Cancer Research Center, the Special Review Committee unanimously recommended that the Fred Hutchison Cancer Research Center, under the direction of Dr. John J. Crowley, be approved as the new Statistical Center for the Southwest Oncology Group. On January The Southwest Oncology Group priority list of open studies can now be downloaded to your Palm Pilot, Pocket PC or other personal digital assistant. The service is being started at a basic level with just the priority list for each disease committee, including open studies by title, drugs, eligible participating institutions, activation date, and for each protocol a link to a separate eligibility criteria page. Downloads are being provided through the AvantGo® mobile Internet service. If you are a regular PDA user, you may already subscribe to some of the many AvantGo channels, ranging from news to entertainment to medical subjects. If so, you can subscribe to the Southwest Oncology Group Priority List in the AvantGo Health/ Healthcare Professionals section. But whether you are a current AvantGo subscriber or not, the easy way to get DECEMBER 2004 31, 1985, the Board of Governors unanimously elected John J. Crowley, Ph.D., as the new Group statistician, authorizing him to make a formal application to the NCI. The rest is history. In preparation for the Fall 2004 Group Meeting Plenary Session recognizing the Statistical Center’s 20 th anniversary, I communicated with Drs. Brown, George and Redmond. They unanimously agreed that presentation of milestones over the past 20 years would be an attractive opportunity for Group members to hear this special part of the Group’s history; therefore, presentations were prepared on data and safety monitoring, person-years saved from therapeutic trials, the design of the Prostate Cancer Prevention Trial, statistical considerations for the PCPT Program Project Grant, the Web-based systems for the accrual of men to the SELECT prostate cancer prevention trial and finally, a discussion of the future plans for the Statistical Center. While the program to honor the Statistical Center had been kept a secret in order to surprise Dr. Crowley, he finally was clued in from the agenda that was distributed just before the plenary session began. What Dr. Crowley also did not know was that his own employees and former employees had been preparing presentations and that Drs. Brown, George and Redmond - members of the infamous Special Review Committee - would soon walk up to the dais to take part in a panel discussion about the Statistical Center’s selection and its progress through the years. Later, the three visitors joined us for a cocktail party followed by dinner in recognition of the astonishing accomplishments of the Southwest Oncology Group Statistical Center. Open study priority list is now available on your PDA connected is to go to the PDA Bulletin Board page on http://swog.org and follow the prompts. After you have subscribed to the Southwest Oncology Group channel and installed the AvantGo software on your PC, when you synchronize your PDA the priority list will automatically be kept up to date for you. If your PDA has wireless Internet access, you can visit the PDA version of the priority list directly by going to http:// swog.org/pda. Depending on usage, other options will be added, such as the ability to select only diseases of interest or protocols approved by local the local institutional review board. Meanwhile, contact the Operations Office with your suggestions, comments, problems or anything else on the subject by sending an e-mail to webmaster@swog.org.
THE GROUP NEWSLETTER Page 3 Operations Office provides orientation for Chair Elect Dr. Baker To get a better understanding of how the Southwest Oncology Group Operations Office supports Group activities, Chair Elect Laurence Baker, D.O., visited the San Antonio office for a two-day orientation October 4 and 5. Baker, who will succeed Group Chairman Charles A. Coltman, M.D., in April 2005, has served as Associate Chair of the Group since 1981. During his orientation, Baker heard presentations from Marjorie Godfrey, Director of the Group’s Operations Office, as well as all Operations Office department heads regarding protocol management, accounting, membership, regulatory affairs, publications, grants, communications, Group meetings, quality assurance and serious adverse events. Also accompanying Baker from the University of Michigan were attorney Anna M. Schork; Denise Reinke, Associate Director for Sarcoma Research; and Robert Barbret, associate director of Financial Operations. When the Group’s leadership changes in April, the Operations Office will remain in San Antonio and Dr. Baker will conduct his chairmanship from the Group Headquarters at DECEMBER 2004 the University of Michigan, while the Group’s Statistical Center will continue to operate in Seattle. From left, Anna M. Schork, University of Michigan attorney; Dr. Charles A. Coltman, Group chairman; Dr. Laurence Baker, chairelect; Robert Barbret, UM associate director of Financial Operations; Denise Reinke, UM associate director for Sarcoma Research; and Marjorie Godfrey, director of the Operations Office. New amendment outlines ‘lost-to-follow-up’ procedures During the Fall 2004 Group Meeting, the Board of Governors approved an amendment to Policy #30, which outlines institutional responsibility for patient follow-up for Southwest Oncology Group trials. This change will for the first time define a formal method to identify a patient as “lost to follow-up (LTF).” This policy refers mainly to patients on therapeutic trials. Information about follow up on participants in the SELECT study will be communicated separately. In order for the LTF-designation to be approved, an institution must document the following: • The institution’s last contact with the patient was at least two years ago. • The institution has made three separate attempts to contact a patient by phone and/or has sent a certified letter which has either been ignored or returned with addressee unknown. • The institution has either searched the National Death Index (NDI) or submitted the patient’s information to the Statistical Center to be included in a periodic NDI search. When these requirements are met, the patient will be designated as “lost to follow-up” in the database and will no longer IATA training video to be available soon for check out Anyone who ships study specimens and was unable to attend the Continuing Education Workshop for IATA Training is encouraged to check out the video which will be available soon. The CRA Committee is working on the details to make it possible for CRAs to watch the video, then take the certification exam. More information will be available in the future. be included in the monthly Expectation and IPR reports. Periodic lists of LTF-patients will continue to be sent as a reminder in case data for such a patient becomes available. The Statistical Center is developing a form to help identify LTF patients, and a notification will be sent out when it is available on the CRA Workbench. The success of Southwest Oncology Group trials continues to rely on the complete and prompt submission of required materials, which has helped ensure that the number of patients who are lostto-follow-up remains small. SWOG Web registrations Since the release of the Southwest Oncology Group Web Registration Program, we have continued to print and mail confirmations of registrations to institutions for the registrations CRAs have conducted on their own. In addition, we have always recommended that you save your confirmations and print them once you are done. However, effective Nov. 1, 2004, we will no longer mail confirmations for registrations done at your site using the Web Registration Program. If you forget to save or print these, you can always contact the Data Operations Center at (206) 652-2267 to request that a copy be sent to you. Please note that we will continue to send any confirmations for registrations that are phoned into the Southwest Oncology Group Data Operations Center.
Page 1: Southwest Oncology Group THE GROUP
Page 5 and 6: THE GROUP NEWSLETTER Newest Young I
Page 7 and 8: THE GROUP NEWSLETTER Page 7 Statist
Page 9 and 10: THE GROUP NEWSLETTER Page 9 An inve
Page 11 and 12: THE GROUP NEWSLETTER Page 11 Publis
Page 13 and 14: THE GROUP NEWSLETTER Page 13 Abstra
Page 15 and 16: THE GROUP NEWSLETTER Page 15 CLOSUR
Page 17 and 18: THE GROUP NEWSLETTER Nurse Onocolog
Page 19 and 20: THE GROUP NEWSLETTER VIDEOTAPE ORDE
Page 21 and 22: THE GROUP NEWSLETTER Clip & Save AD
Page 23: THE GROUP NEWSLETTER Page 23 A gift

Copy of 2003 Group Newsletter 12 15 - SWOG

Create successful ePaper yourself

Delete template?

Save as template?