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Roseann Bonnani, Chair
Research Strategy - Jackie Fisher: (1) A study using Biafine for H&N cancer patients is going to the NCI for second review. (2) A concept for a study using ginseng for lung, breast, and prostate cancer has been forwarded to the RTOG Research Strategy Committee for review. (3) Other concepts in development utilize vitamin E. The CCOPs are very responsive to quality of life concepts.
Education Clare Brooks: The panel presentation and scientific sessions were well received. Deborah Scott and Clare Brooks are stepping down as co-Chairs of the Education Committee. The new co-Chairs will be Dani Zajak, Sharon Prokopf, and Susan Provins.
Quality Control Clare Brooks: The RA Mentoring Committee met together for the first time prior to this RTOG semi-annual meeting to further the plans for this outreach project. The Quality Control Committee is recommending that any institution that is placed on probation be required to avail themselves of a visit from an RA mentor.
Membership Clement Gwede: There are currently 315 registered RAs in the membership database. This is the source from which mailing labels are generated for the RA Reporter, the newsletter specifically for the RTOG RAs.
Communications Committee Kathlyn Drotar is taking over responsibility for this committee.
Disease/Discipline - Joanne Ciconte: This committee enjoyed excellent attendance with many new volunteers coming forward to contribute to this important committee that plays a vital role in the development of RTOG protocols.
Newsletter Larry Korman: The RA Reporter relies on the article contributions from RAs; however, there are specific criteria that must be adhered to. Explanation of this criteria and the reasons why some submissions are significantly edited or perhaps not printed were presented. Only items specific to the Research Associates will be printed in the Reporter, whereas physician quotes or modality details are published in the RTOG newsletter.
Corporate Relations Joyce Neading: The June meeting had the fewest vendors since the vendor program was started, whereas at this meeting, there were a record number. There will be efforts to have more study management software vendors at future meetings.
New Investigators Dani Zajak: With Dani stepping into the co-Chair position for the Education Committee, a new Chair is needed for this RA Committee.
Headquarters Elaine Motyka-Welsh: With the new database transition complete, Forms Due reports will once again be generated for each institution. Headquarters is exploring the option of some data being accepted via special scanning fax for selected protocols. The membership requests that Headquarters post study accrual status reports on the RTOG web site.
Administrators Network Joyce Neading: With feedback from the membership as to interest and suggested timing of this new group, there are plans to include the following type of topics in the RA Educational sessions: Grant writing; budgeting protocols; financial reports; CRA workload survey results; RTOG invoicing; staffing a research office; performance evaluations; Federal regulatory compliance and audit information; overviews of research programs; writing protocol proposals.
RA Membership Committee Roseann Bonnani: We will attempt to have this meeting moved from Saturday to Friday as a working lunch meeting.
Old Business:
RA Handbook Roseann Bonnani: There is one RA Handbook available per institution.
New Business:
Publication Clement Gwede: Clement has had his article regarding the outcome of his workload issues for RAs published in the January and February issues of Applied Clinical Trials.
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Joyce Neading, ART, Chair
Dr. Sophie Turner addressed the committee regarding the RTOG 97-09 Pilocarpine study. After a general overview of the study, Dr. Turner solicited input regarding obstacles to accrual. One of the main issues, and confirmed by JoAnn Stetz as an issue that headquarters receives comments on, is the fact that the pilocarpine is not supplied after the initial 3-month run-in. Evidently, several IRBs are concerned about this as well. Another enrollment obstacle is that the study precludes enrollment of subjects with an unknown primary tumor.
Deborah Scott will be stepping down as Co-Chair of the Research Associates Committee, with Roseann Bonanni assuming this role. JoAnne Ciconte will replace Roseann as chair of the Disease/Discipline Committee.
Several institutions have data management scores that are lower than is acceptable. Dr. Curran is asking that a mentoring program be developed that will lend assistance to these institutions.
The RA poster competition session will now be held once per year at the summer group meeting. There continues to be a $750 travel award offered to the winner of the poster session contest. At the winter group meetings, there will be a how-to poster roundtable.
Education Deb Scott: This meeting, the RA Scientific Session was on Translational Research, and received very favorable comments. As always, input about ideas for future sessions are welcome. Headquarters note: There were 60 people attending the orientation session for RAs held in conjunction with this group meeting.
Membership Clement Gwede: There are currently between 270 275 registered RAs in the membership database. This database generates mailing labels for RA mailings, i.e. RA Reporter.
Communications Darlene Johnson: The objective of this committee is to provide a support network of experienced RAs. Those experienced are encouraged to sign up for inclusion on the listing.
RA Reporter Larry Korman: Any and all RAs are welcome to submit information for inclusion in the RA Newsletter. For those who wish to obtain the guidelines for writing articles, committee reports, etc., can request them from Larry via e-mail of: lormala.jhmi.edu
Disease/Discipline Roseann Bonani: Roseann will be stepping down as Chair of this committee to assume the role of Co-Chair of the RA Committee. JoAnne Ciconte will replace Roseann as chair of the Disease/Discipline Committee. There is a steady need for RAs to participate in the D/D Committee. This is an important position, as the RA is allowed to play an important role in new protocol critique for the betterment of studies.
Research Strategy Jackie Fisher: SoCRA CEU for 1 hour is now available for the Research Strategy Committee. The Biafine study revealed that best supportive care was essentially as effective as Biafine. Women with large breasts benefited from Biafine more; however, with lesser toxicity and time to heal. The general population healing time was better with Biafine. Only 4% of the study entrants were African American. The CCOP Committee has given approval to develop a subsequent study to further evaluate some of the varied findings from the first study. An abstract to be prepared for ASTRO.
In development, Liz Elliott is going forward with the H&N Biafine study. Linda Vocila is planning a vitamin E study for hot flashes in prostate cancer patients. Jackie Fisher is interested in developing a study looking at alternative medicine as intervention for fatigue in lung cancer.
Quality Assurance Clare Brooks: NCI is changing the way audits are scored, focusing separately on 3 areas which are 1) chart review; 2) investigational drug; and 3) IRB review. An institution that fails in one area may be re-audited in that area alone. The score of excellent is being eliminated from the scoring options.
New Investigators Dani Zajac: Many questions are still being asked about what exactly it is that a CRA does. There were also questions on how to find a CRA, and how to know if the CRA that you have is performing well.
Liaison Linda Vocila: SoCRA exam will be offered at the summer meeting. This exam will be advertised geographically, and will be open to non-RTOG members.
Headquarters JoAnn Stetz: The first patient advocacy group has met, and will be reviewing protocols from the patients perspective.
The new group ACRIN has been approved, and will be headquartered as RTOG is at the American College of Radiology.
The pilot program of electronic data submission is underway, and is going very well. This may be widely available by the next RTOG meeting. Among other things, institutions will be able to look at their subjects calendars on line. The ability to transfer films on line is being evaluated.
A new A5 is being developed by the Epidemiology Committee.
LENT is being implemented into several studies.
Some study forms are now available on the web, with more to follow.
Old Business Joyce Neading: CTC is now available on the web. Alert JoAnn Stetz to any problems that you experience with the new CTC. Be aware of which version of the CTC is to be used as different versions are in use. The version in use in determined by the activation date of the protocol.
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