Committee Minutes - CLINICAL TRIALS EDUCATION RECRUITMENT WORKING GROUP   CLINICAL TRIALS EDUCATION RECRUITMENT WORKING GROUP (June, 2007) Eleanor Walker, M.D., Chair Protocol Recruitment Activity RTOG 0214 - Beth Gore is the Study Chair; lead recruitment consultant is Deb Bruner; Assistant recruitment consultant is Eleanor Walker. The Data Monitoring Committee (DMC) has recommended closure of this study due to accrual. The study to date has accrued 331 of the 1058 target patients. RTOG 0320 - Dr. Paul Sperduto is the Principal Investigator; lead recruitment consultant is Joyce Neading; assistant recruitment consultant is Alex Sun. The average monthly accrual is only 2.5 patients per month of the total of 49 patients. An amendment to allow chemotherapy to be given after above treatment and then Temezolomide can be stopped. RTOG 0232 - Dr. Bradley Prestidge is the Principal Investigator; lead recruitment consultant is Sharon Hartson. The DMC has recommended closure of this study, however there is an attempt to amend primary endpoints to reduce sample size. A brochure is available and we will not put any more efforts into recruitment until a decision is made about the amendment and reduced sample size. If the study is amended then we will resurvey successful institutions to aid in recruitment. RTOG 0517 - Mark Seider is the Principal Investigator for this study and lead recruitment consultant is Larry Berk. Novartis sponsored a kick-off luncheon for this study and RTOG 0518. Presentations of studies by Principal Investigators and Clinical Research Associates and lead recruitment consultant with an informal discussion for all along with a video have been done for this protocol. Issues identified are to change wording in eligibility to "complete RT with at least 14 days prior to registration. Other concerns are Medical Oncology notification, education with handout concerning use of nadir of radioisotopes to allow for concurrent chemotherapy and to allow for previous spinal cord compression allowing of brain mets which is already being dealt with. RTOG 0518 - Colleen Lawton is the Principal Investigator; lead recruitment consultant is Patrick Macquire and assistant recruitment consultant is Mary Lou Smith. A video is planned for this study and a handout is being developed. Issues which have been identified are dental assessment timing, whether a dental exam should be performed by MD or a dentist and IV placebo for three years looking at differences between placebo and drug. New Business Cancer Control Trial Recruitment was deferred to Deb Bruner. Acuity Tool for Study evaluation will be handled by Joyce Neading & Jennifer James. Acuity Tool for Study evaluation done for above studies. This will also apply to top 5 accruing RTOG studies and then analyze results For the top 5 RTOG Studies which are RTOG 0525 (Brain), 0413 (breast), 0126 (prostate), 0234 (H&N), 0522 (H&N). RTOG PA Tobacco Funds Study, will study all RTOG studies over last 20 years to evaluate factors associated with attrition. Review of Patient Advocacy Activities Will send brochures +/- videos to pt advocacy groups initially through Mary Lou Smith with videos & link to patient advocacy websites? ECOG has done this. There was a discussion about central IRB versus local IRB only, central IRB is not required for symptom control studies like RTOG 0517 & 0518. A conference call will be scheduled sometime in late September, 2007. RECRUITMENT WORKING GROUP Working Group COMMITTEE (FEBRUARY 2007) Eleanor M. Walker, M.D., Chair Announcements: Deb Bruner will be stepping down as the Chair of the Clinical Trials Education Recruitment Working Group. Drs. Eleanor Walker and Alex Sun will Co-Chair the working group. Deb will still participate in the Clinical Trials Education Recruitment Working Group and oversee it in her position as Vice-Chair for Outcomes. A review of the Clinical Trials Education Recruitment Working Group member responsibilities was performed. Active Studies: RTOG 0214- Dr. Beth Gore the study chair presented the latest numbers in terms of recruitment to this study. Accrual is increasing but still not at the 15 per month needed by 12/31/07. Recommendations included having Sharon Hartson-Stein develop a brochure for the study. Also, Beth will talk with the RTOG top accruing sites. Another suggestion was for a video to be added to the website for PI/CRA information and use. RTOG 0230- Dr. Paul Sperduto the study chair presented the status of accrual to this study. An amendment was submitted to allow more chemotherapy regimens after RT in order to hopefully increase accrual. Also, the fact the radiosurgery can be performed at a different institution that is RTOG accredited will be placed on the website. This information was not made clear and may increase accrual. A slide set about this study is on the website. RTOG will check to see exactly who has downloaded it for use. RTOG 0232- Was not discussed. RTOG 0412- Closed to poor accrual. RTOG 0421- Dr. Stuart Wong the study chair was not present. Dr. Eleanor Walker (lead consultant) reported the study has been closed due to lack of accrual. A recommendation was made to try by the next meeting to determine the exact reason the study was not successful in order to learn from it. RTOG 0518- Dr. Colleen Lawton the study chair was not present but Dr. Pat Maguire who is the lead consultant presented an update on the study. Thus far, 19 patients have been accrued to the study; 6 patients in January 2007 and 7 patients in December 2006. Major barriers to the study appear to be the concern over osteonecrosis of the jaw and there is a placebo arm. Timing of the placebo and drugs is a problem and if started RT then they need to change the eligibility. Novartis has offered to partner with the RTOG to improve recruitment to this study and RTOG 0517. Possibly developing video clips for use on the website, distribution, patient and physician information about ONJ. A meeting with Novartis is scheduled after the Clinical Trials Education Recruitment Working Group meeting to discuss this potential partnership in more detail. Marylou Smith presented the results of the survey to the patient advocacy groups. Ninety-nine percent (99%) of groups were willing to put RTOG information on their websites but 88% wanted us to prepare the information. Ninety-five (95%) wanted to be contacted by RTOG with information. Seventy-five (75%) of patient advocacy organizations were aware of RTOG. Joyce Neading reported on a new tool being analyzed for use called the "acuity complexity analysis." This tool would potentially help to determine if a study would be successful prior to opening it. A suggestion was made to retrospectively use it on closed studies as a validation. Jennifer James at headquarters will be working on this. Finally a discussion about developing a marketing package for each new study occurred. RECRUITMENT WORKING GROUP Working Group COMMITTEE (June 2006) Eleanor Walker, M.D., Chair for Deborah W. Bruner, Ph.D., Chair Introduction of new Co-Chair, Dr. Alex Sun Review Working Group Member Responsibilities Per the sheet sent out by Deb Bruner prior to the meeting, we reviewed committee member responsibilities. Copies were given to all present and they were requested to contact myself, Deb or Alex with any questions or problems. A list of people who wish to be on the CTER committee were identified. Review Recruitment Activity Log A template of the activity log sent out by Deb Bruner was also circulated for review and comments. Review Protocol Recruitment Activity RTOG 0214 – Study Chair Beth Gore Lead recruitment consultant Deb Bruner Assistant recruitment consultant Eleanor Walker RTOG 0421 – PI Stuart Wong Lead recruitment consultant Eleanor Walker Assistant recruitment consultant Clement Gwede RTOG 0412 – PI Maria Werner-Wasik (Not present at the meeting) Lead recruitment consultant Beth Gore Assistant Recruitment consultant Eleanor Walker RTOG 0320 – PI Paul Sperduto Lead recruitment consultant Joyce Neading Assistant recruitment consultant Alex Sun RTOG 0232 – PI Brad Prestidge (Not present at the meeting) Lead recruitment consultant Sharon Harston A review of the first study, Dr. Gore’s PCI study, results after the implementation of recommendations, from the survey was reviewed. There was an increase in the numbers of accruals. Recommendations to further increase accrual were made i.e. promoting the study through CTSU and other cooperative groups. The other studies in trouble were presented to the group by their PIs and preliminary recommendations were made to help increase accrual. Basically each study (RTOG 0421, #0412, #0320, and #0232) will need to accrue 5 patients by 11/06 or they will be closed. Ideas as were made about ways to increase accrual in addition to the specific survey questions that will be sent out for each protocol. The study specific questions should be determined and sent out by August at the latest. They included: Identification of practitioners who believe in the specific study and will accrue patients to the study. Determine the 6-9 months accrual rates for newly opened studies as a predictor of their ability to meet projected accrual numbers. Reinstate the circulation of protocol concept sheets to RTOG institutions so they could be reviewed by IRBs in preparation for study opening. Send slides (PowerPoint) to CTSU, other cooperative groups and specific study Chairs for placement on their websites and presentations at their meetings. Publicize. Send out review articles and background information for ongoing research in CLC, Oncology and other throw away journals. For each of the 5 studies, a review of the assigned primary and secondary recruitment consultants were performed. It was suggested each group get together at this meeting to discuss their plans for recruitment and determination of their specific survey questions. Sharon Hartson will be the main point person for all the survey questions. Review Patient Advocacy Activities Survey to Patient Advocacy Organizations Finally, the committee was notified the recruitment abstract was accepted for oral presentation at ASTRO on November 8, 2006. RECRUITMENT WORKING GROUP Working Group COMMITTEE (January 2006) Deborah W. Bruner, Ph.D., Chair The recruitment survey subcommittee drafted and circulated a questionnaire to all RTOG Principal Investigators and Research Associates to assess attitudes and beliefs regarding clinical trials recruitment in general and reasons for slow accrual to two specific trials, the GU brachytherapy study RTOG 0232 and the Lung PCI study RTOG 0214. The survey is also being circulated at this RTOG meeting to increase the number of responses. A preliminary review of selected items was discussed. Preliminary Review of Survey RTOG 0214 PCI for NSCLC: We need to review the % of institutions with the study open verses the number of respondents. Small % of institutions answering do not support the treatment options. Respondents indicated almost a third of patient refusal due to pREFERENCES for another treatment modality. Physicians forget to offer the study to patients after completing chemotherapy. The question was raised as to whether or not one could consent the patient before the initiation of treatment (CT/RT). Preliminary Recommendations for RTOG 0281: Monthly email reminders to the people who have IRB approval. Beth should work with Sharon to develop and email a list to send a reminder to both the PI and RA of each participating institution. In addition this should be sent to members of the lung committee and any other person important to study accrual. Beth will draft initial letter to institutions using ID#. Monthly emails should including the accrual # at the end of each month. Accrual and study strategies should be included in the email reminder in addition to toxicities if any. RTOG 0232 Prostate Brachytherapy: The obstacles involved with this study are credentialing (only small %) and a large % of respondents indicated patient treatment pREFERENCES were a major barrier. There were no recommendations at this time. The preliminary results suggested there were some differences between how RA and how MDs recruit patients to studies. Suggestions were made as to how to assess this difference. We could possibly apply for a grant , train physicians and research associates in communication with patients, develop a "scripting" for clinical trial presentation where we have a contact (Terry at Karmanos) and have a session during the RTOG Semi-Annual meeting for presentation to patient vignettes.