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Julia R. White, M.D., Chair
The overall role and function of the New Investigators Committee within RTOG was explained. A brief overview was given of RTOG activities and structure.
The New Investigators Committee is a resource for New Investigators was reviewed. This is composed of more senior investigators in RTOG that represent each of the site, delivery, and standing committees and includes key staff members from Headquarters. The goal of this committee is to help New Investigators navigate and become more active in RTOG activities. The members of this committee and e-mails addresses were provided.
Opportunities for New Investigators were reviewed, including the Translational Research Committee Seed Grant Program, Simon Kramer New Investigator Award, and RTOG Varian Resident Travel Award. In addition copies of the Protocol Concept Form, Request of Secondary Analysis Form, and the application process for The Translational Research Committee Seed Grant Program were handed out. A handout summarizing the protocol development process was provided.
Two speakers provided additional information. Kathryn Winter, RTOG Senior Statistician, presented, "The Role of the Statistician from Concept through Publication." This provided new investigators a detailed review of protocol development, management and analysis. Elizabeth Gore MD, Study Chair, reviewed her experience as PI on RTOG 0214, "A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients with Locally Advanced Non-Small Cell Lung Cancer."
Additional handouts including general information about headquarters staff and a list of active RTOG committees were provided to those in attendance. A survey was provided to new investigators for feedback regarding what this committee can do to enhance their involvement within the group.
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Julia R. White, M.D., Chair
The overall role and function of the New Investigators Committee within RTOG was explained. A brief overview was given of RTOG activities and structure.
The New Investigator's Committee as a resource for New Investigators was reviewed. The committee is composed of more senior investigators in RTOG that represent each of the site, delivery, and standing committees and includes key staff members from Headquarters. The goal of this committee is to help mentor New Investigators navigate and become more active in RTOG activities. The members of this committee and e-mails addresses were provided.
Opportunities for New Investigators were reviewed, including the Translational Research Committee Seed Grant program, Simon Kramer New Investigator Award, and RTOG-Varian Resident Travel Award. In addition copies of the Protocol Concept Form, Request of Secondary Analysis Form, and the application process for The Translational Research Committee Seed Grant program were handed-out. A handout summarizing the protocol development process was provided
Wilma Hoffman, Director of Protocol Development and Regulatory Compliance at RTOG Headquarters presented, "The Role and Responsibilities of the Principal Investigator." She reviewed for new investigators the expectations and responsibilities of a study chair from concept through publication.
Ivy Peterson MD, reviewed with new investigators the, "Activities and Opportunities for New Investigator in the Sarcoma Committee." In particular, she provided insight for new investigators interested in becoming more involved in the Sarcoma Committee and RTOG in general.
Barbara Fisher MD, spoke about, "The Experience of a Principal Investigator: RTOG 0424 Temozolomide-based ChemoRadiotherapy for High Risk Low-Grade Glioma." She related to new investigators the process and challenges of developing and overseeing an RTOG clinical trial.
Additional handouts including general information about headquarters staff and a list of active RTOG committees were provided to those in attendance. A survey was provided to new investigators for feedback regarding what this committee can do to enhance their involvement within the group.
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Julia R. White, M.D., Chair
The overall role and function of the New Investigators Committee within RTOG was explained. A brief overview was given of RTOG activities and structure.
The New Investigator's Standing Committee as a resource for New Investigators was reviewed. The committee is composed of more senior investigators in RTOG that represent each of the site, delivery, and standing committees and includes key staff members from Headquarters. The goal of this committee is to help mentor New Investigators navigate and become more active in RTOG activities. The members of this committee and e-mails addresses were provided.
Opportunities for New Investigators were reviewed, including the Translational Research Committee Seed Grant program, Simon Kramer New Investigator Award, and RTOG-Varian Resident Travel Award. In addition copies of the Protocol Concept form, Request of Secondary Analysis form, and the application process for The Translational Research Committee Seed Grant program were handed out. A handout summarizing the protocol development process was provided.
Kathryn Winter, RTOG Senior Statistician presented the "Role of the Statistician" from Concept through Publication." She reviewed in detail the steps for protocol development, activation, monitoring, analysis and publication.
David Gaffney MD, PhD, Chair, Gynecology Working Group reviewed the activities and opportunities for New Investigators in the Gynecology Working Group. In particular, he reviewed ways a new investigator can become more involved.
Additional handouts including general information about headquarters staff and a list of active RTOG committees were provided to those in attendance. A survey was provided to new investigators for feedback regarding what this committee can do to enhance their involvement within the group.
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Julia R. White, M.D., Chair
All in attendance were welcomed to the meeting. The overall role and function of the New Investigators Committee within RTOG was explained. A brief overview was given of RTOG activities and structure.
The New Investigator's Standing Committee as a resource for New Investigators was reviewed. The committee is composed of more senior investigators in RTOG that represent each of the site, delivery, and standing committees and includes key staff members from Headquarters. The goal of this committee within the New Investigators Committee is to help mentor New Investigators to understand and become more active within the group and individual committee. The members of this committee and e-mails addresses were provided.
Opportunities for New Investigators were reviewed, including the Translational Research Committee Seed Grant program, Simon Kramer New Investigator Award, and RTOG-Varian Resident Travel Award. In addition copies of the Protocol Concept form, Request of Secondary Analysis form, and the application process for The Translational Research Committee Seed Grant program were handed-out. A handout summarizing the protocol development process was provided. Additional handouts included general information about headquarters staff and a list of active RTOG committees. A survey was provided to new investigators for feedback regarding what this committee can do to enhance their involvement within the group.
Wilma Hoffman, Director of Protocol Development and Regulatory Compliance outlined the, "The Role and Responsibilities of the PI" in an RTOG protocol. She clearly emphasized to new investigators the steps involved as a PI on a trial from concept through accrual.
Julia White reviewed the current and developing activities of the breast committee. In particular, how a new investigator can bring a new concept to the committee was emphasized.
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Julia R. White, M.D., Chair
All in attendance were welcomed to the meeting. The overall role and function of the New Investigators Committee within RTOG was explained. A brief overview was given of RTOG activities and structure.
Dr. Mack Roach, senior investigator for the Genitourinary Cancer Committee, presented, “Insights for New Investigators in RTOG.” He presented his experience with protocol development and committee activities. Practical advice and ideas were provided for how new investigators can become more active within RTOG.
Kathryn Winter MS, RTOG Senior Statistician, presented, “The Statistician’s Role from Protocol Development through Final Analysis of Study Results.” The processes for protocol development, activation, and management were reviewed in detail with particular emphasis on the position and responsibility of the statisticians.
The New Investigator’s Standing Committee as a resource for New Investigators was reviewed. The committee is composed of more senior investigators in RTOG that represent each of the sites, delivery, and standing committees and includes key staff members from Headquarters. The goal of this committee within the New Investigators Committee is to help mentor New Investigators to understand and become more active within the group and individual committee. The members of this committee and e-mails addresses were provided.
Opportunities for New Investigators were reviewed, including the Translational Research Committee Seed Grant program, Simon Kramer New Investigator Award, and RTOG-Varian Resident Travel Award. In addition copies of the Protocol Concept form, Request of Secondary Analysis form, and the application process for The Translational Research Committee Seed Grant program were handed-out. A handout summarizing the protocol development process was provided. Additional handouts included general information about headquarters staff and a list of active RTOG committees. A survey was provided to new investigators for feedback regarding what this committee can do to enhance their involvement within the group.
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Julia R. White, M.D., Chair
All members were welcomed to the New Investigators Committee meeting. The overall role and function of the New Investigators Committee was explained. A brief overview was given of RTOG history, activities, and structure. The protocol development process was reviewed and in particular how a new investigator can bring an idea for a protocol to the group was stressed. A handout summarizing the protocol development process was provided. Additional handouts included general information about headquarters staff and a list of active RTOG committees.
The New Investigator’s Standing Committee as a resource for New Investigators was reviewed. The committee is composed of more senior investigators in RTOG who represent each of the site, delivery, and standing committees and includes key staff members from Headquarters. The goal of this committee within the New Investigators Committee is to help mentor New Investigators to understand and become more active within the group and individual committee. The members of this committee and e-mails addresses were provided.
Dr. Andy Trotti, Co-chair Head & Neck Cancer Committee, expanded on the role for new investigators within RTOG. He presented his experience with protocol development and committee activities. Practical advice and ideas were provided for how new investigators can become more active within RTOG. Also, Dr. Mitchell Machtay, Deputy Chair RTOG, reinforced the many ways for New Investigators to become involved in the group’s work.
Opportunities for New Investigators were reviewed, including the Translational Research Committee Seed Grant program, Simon Kramer New Investigator Award, and Varian Resident Travel Award. In addition copies of the Protocol Concept form, Request of Secondary Analysis form, and the application process for The Translational Research Program Seed Grant program were handed out. A survey was provided to new investigators for feedback regarding what this committee can do to enhance their involvement within the group.
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Julia R. White, M.D., Chair
All in attendance were welcomed to the RTOG New Investigators Committee meeting. Most present indicated they were attending their first RTOG Semi-Annual meeting. The overall role and function of the New Investigators Committee was reviewed.
In order to provide an information network that is accessible to New Investigators a committee has been established of more senior investigators in RTOG to represent each of the sites, delivery, and standing committees and includes key staff members from Headquarters. The goal of this new committee within the New Investigators Committee is to provide easier access for New Investigators to the group’s and individual committee’s activities. The members of this committee and e-mails addresses were provided.
Advice for how new investigators can become more active within RTOG was provided. The protocol development process was reviewed and in particular how a new investigator can bring an idea for a protocol to the group was stressed. The role of the New Investigators Committee to assign a new investigator representative to an active committee for a period of one year was explained. Forms for a committee appointment beginning June 2005 were distributed for completion and collected. Other opportunities for New Investigators were reviewed, including the Translational Research Committee Seed Grant program, Simon Kramer New Investigator Award, and RTOG-Varian Resident Travel Award.
Dr. Paul Okunieff, Chair of the Translational Research Program, presented the overall organization and goals of this program and expressed enthusiasm for including new investigators. He more fully reviewed the Seed-Grant program for translational and correlative studies, and outlined the process for application.
Dr. Benjamin Movsas, gave a general overview of the activities of the Outcomes Committee. He provided ideas for how New Investigators can become more involved in the committee’s work.
Joanne Ley, Senior RTOG Research Associate, reviewed the importance and common pitfalls of Data Management for developing and ongoing RTOG protocols.
Multiple handouts were provided. These included examples of a Protocol Concept sheet, list of active committees, Request of Secondary Analysis, Application process for The Translational Research Committee Seed Grant program. A survey was provided to new investigators for feedback regarding what this committee can do to enhance their involvement within the group.
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Julia R. White, M.D., Chair
Members were welcomed to the RTOG New Investigators Committee meeting. Most present indicated that they were attending their first RTOG Semi-Annual Meeting. The overall role and function of the New Investigators Committee was reviewed.
Different ways for new investigators to become more active within RTOG were discussed. The protocol development process was reviewed and in particular how a new investigator can bring an idea for a protocol to the group was stressed. The role of the New Investigators Committee to assign a new investigator representative to an active committee for a period of one year was explained. Forms for a committee appointment beginning June 2004 were distributed for completion and collected. Other opportunities for new investigators were reviewed, including the Translational Research Committee Seed Grant program, Simon Kramer New Investigator Award, and RTOG-Varian Resident Travel Award.
Dr. Paul Okunieff, Chair of the Translational Research Program, presented the overall organization and goals of this program and expressed enthusiasm for including new investigators. He more fully reviewed the Seed-Grant program for translational and correlative studies, and outlined the process for application.
Dr. Mitchell Machtay, Deputy Chair of RTOG, gave a general overview of RTOG structure and activities. He provided ideas and direction for how New Investigators can begin to become involved in the groups’ work.
Kathryn Winter, Senior RTOG Statistician reviewed the protocol development process in detail through concept to final analysis and outlined the statistician's role.
Multiple handouts were provided. These included examples of a Protocol Concept sheet, list of active committees, Request of Secondary Analysis, Application process for The Translational Research Committee Seed Grant program. A survey was provided to new investigators for feedback regarding what this committee can do to enhance their involvement within the group.
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Julia R. White, M.D., Chair
All members were welcomed to the RTOG New Investigators Committee meeting. The overall role and function of the New Investigators Committee was explained. A brief overview was given of RTOG history, activities, and structure. The protocol development process was reviewed and in particular how a new investigator can bring an idea for a protocol to the group was stressed. A handout summarizing the protocol development process was provided. Additional handouts included general information about headquarters staff and a list of active RTOG committees.
Opportunities for New Investigators, including The Translational Research Committee Seed Grant program, the New Investigator Award, and the Resident Travel Award were reviewed and the process for application provided as a handout.
The role of the New Investigators Committee to designate a new investigator representative to an active committee for a period of one year was explained. Forms for committee appointment that will begin in 2004 were distributed for completion and collected. Two speakers followed allowing new investigators to interact with and ask questions of more experienced investigators.
The first speaker was Dr. Hak Choy, Chair of the Lung Cancer Committee who reviewed the current and developing studies of this committee. The second speaker was Dr. Lawrence Berk, Chair, CCOP Membership Evaluation Committee, who explained CCOP’s and their active and future studies within RTOG. Each speaker emphasized how New Investigators can become involved in the committee process.
Surveys were provided to those present for feedback about what this committee can do to enhance the activity of new investigators within the group.
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Julia R. White, M.D., Chair
All members were welcomed to the RTOG New Investigators Committee meeting. The overall role and function of the New Investigators Committee was reviewed. A brief overview was given of RTOG history, activities, and structure. The protocol development process was reviewed and in particular how a new investigator can bring an idea for a protocol to the group was stressed. A handout summarizing the protocol development process was provided. Additional handouts included general information about headquarters staff and a list of active RTOG committees.
The role of the New Investigators Committee is to designate a New Investigator representative to an active committee for a period of one year was explained. Forms for committee appointment that will begin June 2003 were distributed for completion and collected. A discussion about how to make this experience more meaningful to New Investigators then followed. The need for mentoring of newer investigators both within each committee, and the organization as a whole, was discussed. Surveys were provided to new investigators for feedback about what this committee can do to enhance activity of new investigators within RTOG.
Two speakers followed allowing new investigators to interact with and ask questions of more experienced investigators. The first speaker was Kathryn Winter, Senior RTOG Statistician, who reviewed in detail the protocol development process through concept to final analysis. In particular, she outlined the statistician's role at each phase of protocol development, activation, and analysis. The next speaker was Paul Okunieff, M.D., Chair of the Translational Research Program, outlined the past accomplishments and future goals of this program. Specifically, he reviewed the opportunities for New Investigators within the Translational Research Program. Dr. Okunieff, also explained the Seed Grant program for support of translational or correlative research proposals that are hoped to grow into full RTOG studies. The process for application was reviewed.
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Julia R. White, M.D., Chair
All members were welcomed to the New Investigators Committee meeting. The overall role and function of the New Investigators Committee was reviewed. A brief overview was given of RTOG history, activities, and structure. The protocol development process was reviewed and in particular how a new investigator can bring an idea for a protocol to the group was stressed. A handout summarizing the protocol development process was provided. Additional handouts included general information about headquarters staff and a list of active RTOG committees. The Translational Research Committee Seed Grant program and the New Investigator Award were reviewed and the process for application was provided as a handout.
The role of the New Investigators Committee to designate a new investigator representative to an active committee for a period of one year was explained. Forms for committee appointment that will begin June 2003 were distributed for completion and collected. Two speakers followed allowing new investigators to interact with and ask questions of more experienced investigators.
The first speaker was Dr. Christopher Willet, Chair of the Gastrointestinal Cancer Committee who reviewed the past achievements and active protocols of this committee. Additionally, he discussed developing protocols and how a new investigator can bring a concept for a protocol to the committee.
The next speaker was Dr. Elizabeth Gore, Study Chair of L-0213, a Phase I/II Study of the Cox-2 Inhibitor, Celebrexä, with Limited Field Radiation for Intermediate Prognosis Patients with Locally Advanced Non-Small Cell Lung Cancer, with Analysis of Prognostic Factors. Dr. Gore reviewed the rationale and scheme for this study. She explained how the concept was introduced to the Lung Cancer Committee and the many transformations the study underwent as it moved through the group process from concept to active protocol.
Surveys were provided to new investigators for feedback about what this committee can do to enhance activity of new investigators within the group.
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Julia R. White, M.D., Chair
All members were welcomed to the RTOG New Investigators Committee meeting. The overall role and function of the New Investigators Committee was reviewed. A brief overview was given of RTOG history, activities, and structure. The protocol development process was reviewed and in particular how a new investigator can bring an idea for a protocol to the group was stressed. A handout summarizing the protocol development process was provided. Additional handouts included general information about headquarters staff, summary of active protocols, a CCOP description and a list of active RTOG committees.
The role of the New Investigators Committee to appoint a new investigator representative to an active committee for a period of one year was explained. Forms for committee appointment that will begin June 2002 were distributed for completion and collected. Multiple speakers followed allowing new investigators to interact with and ask questions of more experienced investigators and headquarters staff.
The first speaker was Dr. Mohammed Mohiuddin, Study Chair of R-0012, and a Randomized Phase II Trial of Preoperative Chemoradiation for Distal Rectal Cancer. Dr. Mohiuddin explained the protocol’s rationale, scheme and its evolution through the protocol development process.
The next speaker was Dr. William Small, Study Chair of RTOG C-0116. This is a Phase I/II Study of Extended Field RT and Intracavitary Brachytherapy Combined with Chemotherapy and Amifostine in High Risk, Node Positive Cervical Cancer. Dr. Small similarly explained the rationale and scheme for this study. He emphasized how the concept was brought to the group and its changes as it developed into the current study through the protocol development process.
The third speaker was Dr. Roger Byhardt, the Principal Investigator at the Medical College of Wisconsin who did a presentation on successful methods for introducing protocol participation to patients. Dr. Byhardt reviewed practical strategies for approaching patients for enrollment in RTOG trials.
Dr. Paul Okunieff, Chair of the Translational Research Program, presented the overall organization and goals of this program and expressed enthusiasm for including new investigators. He reviewed the seed-grant program for up to $10,000.00 for translational, correlative studies, which are hoped to grow into full RTOG studies. The process for application was reviewed.
Lastly, Kathryn Winter, Senior RTOG Statistician reviewed the protocol development process through concept to final analysis and outlined the statistician's role.
Surveys were provided to new investigators for feedback in what this committee can do to enhance activity of new investigators within the group.
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Julia R. White, M.D., Chair
All members were welcomed to the RTOG New Investigators Committee meeting. The overall role and function of the New Investigators Committee was reviewed. A brief history and overview of RTOG was given. A series of handouts were provided. These included general information about headquarters staff, including phone numbers, e-mail addresses, summary of the active protocols, the RTOG procedure manual, CCOP description and a list of active RTOG committees. The role of the New Investigators Committee to appoint a new investigator representative to an active committee for a period of one year was explained. Forms for committee appointment that will begin June 2002 were distributed for completion. A series of speaker presentations then followed.
Joanne Ley, R.N., Senior Research Associate at RTOG Headquarters reviewed the overall organization and responsibilities of the Data Management Department. This included protocol development, form design, data review, quality assurance, new research associates orientation, and sources for principle investigators and research associates. She also reviewed principal investigator obligations as well as data submission obligations for protocols.
Elaine Callahan, Senior Quality Control Auditor from RTOG Headquarters, reviewed the process for auditing full and affiliate members. She outlined the role for physician auditors in full-member institution audits and outlined how this would be an opportunity for new investigators to become more active within the group.
The next speaker was Dr. David Rosenthal, Study Chair for RTOG study H-0024. This is a Phase II trial of early post-operative Paclitaxel followed by Paclitaxel and Cisplatin concurrent with radiation therapy for resected high risk squamous cell carcinoma of the head and neck. Dr. Rosenthal outlined the background, rationale, eligibility, accrual goals, and treatment schema for the study.
The next speaker was Dr. Paul Okunieff, Chair of the Translational Research Program. Dr. Okunieff expressed enthusiasm for including new investigators in the Translational Research Program. He outlined the overall organization and goals of this program. He reviewed the seed grant program for up to $10,000.00 for translational/correlative studies which are hoped to grow into full RTOG studies. The process for application was reviewed and a due date of 1 month prior to the RTOG group meetings noted.
Dr. Mehta Minesh, Chair of the Brain Tumor Committee, outlined the activities of this committee. He reviewed the achievements of the Brain Tumor Committee over the past 5 years. He outlined future areas of studies and welcomed participation from new investigators in these areas: dose escalation, functional imaging, angiogenesis inhibitors in radiation therapy, and novel biologic modulators for various combinations of chemotherapy and radiation therapy response.
Our last speaker was Linda Vocila, B.S.N., R.N., who is the research associate representative to the New Investigators Committee. She updated the committee on the activities of the research associates. She outlined for new investigators resources available at headquarters and the research associates organizations for the research associates at their institutions.
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Julia White, M.D., Chair
All members were welcomed to the New Investigators Committee meeting. A series of handouts were provided. These included general information about headquarters staff, including phone numbers and email addresses, summary of the active protocols, the RTOG procedure manual, a CCOP description and a list of active RTOG committees.
The overall role and function of the New Investigators Committee was reviewed. A brief overview was given of RTOG. This included a history, group objectives, committee organization, and types and requirements for institutional membership. Then, the steps involved for protocol development were reviewed. In particular how a new investigator can bring an idea for a new protocol to the group was discussed. A handout summarizing the protocol development process was provided.
The role of the New Investigators Committee to appoint a new investigator representative to the active committees for a period of one year was explained. Forms for committee appointment that will begin June 2001 were distributed for completion.
The first speaker was Joanne Ley, R.N., from Headquarters in the Data Management Department. She reviewed the overall organization of this department and the data management responsibilities. These include protocol development, forms design, data review and quality assurance, new Research Associates orientation and resources for Principal Investigators and Research Associates. She provided more detail for each of these responsibilities. She then reviewed some of the challenges the data management department faces and how investigators can help avoid these. She reviewed the data forms for submission and reviewed the process as to what happens to this information once it is sent to headquarters. She provided resources for investigators regarding issues they may have with the data management department.
The next speaker with Linda Vocila, B.S.N., R.N. a clinical research nurse who is the research associates representative to the New Investigators Committee. She reviewed the role of the research associate in assisting investigators. This includes both direct patient and non-patient roles.
Dr. Beryl McCormick, Chair of the Breast Cancer Committee was our final speaker. She reviewed the background for the reformation of the Breast Cancer Committee within RTOG. She outlined new protocols completed and the current emphasis of the Breast Cancer Committee. She reviewed the DCIS protocol opened within the last six months, RTOG 98-04, in particular stressing the eligibility, pathology web based teaching system, and treatment arms.
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