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James H. Doroshow - One of the best experts on this subject based on the ideXlab platform.
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The Cancer Therapy Evaluation Program’s (CTEP) implementation of the Operational Efficiency Working Group (OEWG) recommendations.
Journal of Clinical Oncology, 2011Co-Authors: Kate Dipiazza, James A. Zwiebel, Shanda Finnigan, Erin Souhan, Andrea Denicoff, Steve Friedman, Mike Montello, Margaret Mooney, P. Schettino, James H. DoroshowAbstract:6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitte...
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the cancer therapy evaluation program s CTEP implementation of the operational efficiency working group oewg recommendations
Journal of Clinical Oncology, 2011Co-Authors: Kate Dipiazza, James A. Zwiebel, Shanda Finnigan, Erin Souhan, Andrea Denicoff, Steve Friedman, Mike Montello, Margaret Mooney, P. Schettino, James H. DoroshowAbstract:6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitte...
Shanda Finnigan - One of the best experts on this subject based on the ideXlab platform.
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The Cancer Therapy Evaluation Program’s (CTEP) implementation of the Operational Efficiency Working Group (OEWG) recommendations.
Journal of Clinical Oncology, 2011Co-Authors: Kate Dipiazza, James A. Zwiebel, Shanda Finnigan, Erin Souhan, Andrea Denicoff, Steve Friedman, Mike Montello, Margaret Mooney, P. Schettino, James H. DoroshowAbstract:6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitte...
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the cancer therapy evaluation program s CTEP implementation of the operational efficiency working group oewg recommendations
Journal of Clinical Oncology, 2011Co-Authors: Kate Dipiazza, James A. Zwiebel, Shanda Finnigan, Erin Souhan, Andrea Denicoff, Steve Friedman, Mike Montello, Margaret Mooney, P. Schettino, James H. DoroshowAbstract:6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitte...
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A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of CTEP-sponsored studies
Journal of Clinical Oncology, 2009Co-Authors: Steven K. Cheng, M. S. Dietrich, Shanda Finnigan, Alan Sandler, J. Crites, L. Ferranti, David M. DiltsAbstract:CRA6509 Background: Post-activation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. Methods: National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) sponsored trials for all therapeutic, non-pediatric phase I,I/II, II, and III studies activated in an eight year period (2000–2007) were investigated (n=553). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trialactivation. Multivariable logistic regression analysis was used tocalculate unadjusted and adjusted odds ratios, controlling for study phase and size of expected accruals. Results: 40.0 percent (n=221) of CTEP-approved oncology trials failed to achieve minimum accrual goals, with 49.2 percent (n=30) of phase III trials failing to achieve at least 25 percent of accrual goals. A total of 8,723 patients (17.0% of...
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Steps and Time to Process Clinical Trials at the Cancer Therapy Evaluation Program
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009Co-Authors: David M. Dilts, Steven K. Cheng, Shanda Finnigan, Alan Sandler, J. Crites, L. Ferranti, Margaret Mooney, Steven H. Friedman, Jeffrey AbramsAbstract:Purpose To examine the processes and document the calendar time required for the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) and Central Institutional Review Board (CIRB) to evaluate and approve phase III clinical trials. Methods Process steps were documented by (1) interviewing CTEP and CIRB staff regarding the steps required to activate a trial from initial concept submission to trial activation by a cooperative group, (2) reviewing standard operating procedures, and (3) inspecting trial records and documents for selected trials to identify any additional steps. Calendar time was collected from initial concept submission to activation using retrospective data from the CTEP Protocol and Information Office. Results At least 296 distinct processes are required for phase III trial activation: at least 239 working steps, 52 major decision points, 20 processing loops, and 11 stopping points. Of the 195 trials activated during the January 1, 2000, to December 31, 2007, study period, a ...
David M. Dilts - One of the best experts on this subject based on the ideXlab platform.
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Clinical Trial Development as a Predictor of Accrual Performance—Response
Clinical Cancer Research, 2011Co-Authors: Steven K. Cheng, David M. DiltsAbstract:We thank Schoen for her comments and insights into accrual performance. The primary purpose of our research was to reveal the relationship between development time of National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP)-supported trials and a standard accrual milestone that was
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A Sense of Urgency: Evaluating the Link between Clinical Trial Development Time and the Accrual Performance of Cancer Therapy Evaluation Program (NCI-CTEP) Sponsored Studies
Clinical cancer research : an official journal of the American Association for Cancer Research, 2010Co-Authors: Steven K. Cheng, M. S. Dietrich, David M. DiltsAbstract:Purpose: Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. Experimental Design: National Cancer Institute Cancer Therapy Evaluation Program (CTEP)–sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period ( n = 419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), controlling for study phase and size of expected accruals. Results: Among the CTEP-approved oncology trials, 37.9% ( n = 221) failed to attain the minimum accrual goals, with 70.8% ( n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients (42.5% of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development times of 12 to 18 months. Trials requiring a development time of greater than 24 months were significantly less likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than trials with the median development time. Conclusions: A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. Clin Cancer Res; 16(22); 5557–63. ©2010 AACR.
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A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of CTEP-sponsored studies
Journal of Clinical Oncology, 2009Co-Authors: Steven K. Cheng, M. S. Dietrich, Shanda Finnigan, Alan Sandler, J. Crites, L. Ferranti, David M. DiltsAbstract:CRA6509 Background: Post-activation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. Methods: National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) sponsored trials for all therapeutic, non-pediatric phase I,I/II, II, and III studies activated in an eight year period (2000–2007) were investigated (n=553). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trialactivation. Multivariable logistic regression analysis was used tocalculate unadjusted and adjusted odds ratios, controlling for study phase and size of expected accruals. Results: 40.0 percent (n=221) of CTEP-approved oncology trials failed to achieve minimum accrual goals, with 49.2 percent (n=30) of phase III trials failing to achieve at least 25 percent of accrual goals. A total of 8,723 patients (17.0% of...
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Steps and Time to Process Clinical Trials at the Cancer Therapy Evaluation Program
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009Co-Authors: David M. Dilts, Steven K. Cheng, Shanda Finnigan, Alan Sandler, J. Crites, L. Ferranti, Margaret Mooney, Steven H. Friedman, Jeffrey AbramsAbstract:Purpose To examine the processes and document the calendar time required for the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) and Central Institutional Review Board (CIRB) to evaluate and approve phase III clinical trials. Methods Process steps were documented by (1) interviewing CTEP and CIRB staff regarding the steps required to activate a trial from initial concept submission to trial activation by a cooperative group, (2) reviewing standard operating procedures, and (3) inspecting trial records and documents for selected trials to identify any additional steps. Calendar time was collected from initial concept submission to activation using retrospective data from the CTEP Protocol and Information Office. Results At least 296 distinct processes are required for phase III trial activation: at least 239 working steps, 52 major decision points, 20 processing loops, and 11 stopping points. Of the 195 trials activated during the January 1, 2000, to December 31, 2007, study period, a ...
Kate Dipiazza - One of the best experts on this subject based on the ideXlab platform.
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The Cancer Therapy Evaluation Program’s (CTEP) implementation of the Operational Efficiency Working Group (OEWG) recommendations.
Journal of Clinical Oncology, 2011Co-Authors: Kate Dipiazza, James A. Zwiebel, Shanda Finnigan, Erin Souhan, Andrea Denicoff, Steve Friedman, Mike Montello, Margaret Mooney, P. Schettino, James H. DoroshowAbstract:6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitte...
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the cancer therapy evaluation program s CTEP implementation of the operational efficiency working group oewg recommendations
Journal of Clinical Oncology, 2011Co-Authors: Kate Dipiazza, James A. Zwiebel, Shanda Finnigan, Erin Souhan, Andrea Denicoff, Steve Friedman, Mike Montello, Margaret Mooney, P. Schettino, James H. DoroshowAbstract:6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitte...
James A. Zwiebel - One of the best experts on this subject based on the ideXlab platform.
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Radiation-Therapeutic Agent Clinical Trials: Leveraging Advantages of a National Cancer Institute Programmatic Collaboration.
Seminars in radiation oncology, 2016Co-Authors: Naoko Takebe, Mansoor M. Ahmed, Bhadrasain Vikram, Eric J. Bernhard, James A. Zwiebel, C. Norman Coleman, Charles A. KunosAbstract:A number of oncology phase II radiochemotherapy trials with promising results have been conducted late in the overall experimental therapeutic agent development process. Accelerated development and approval of experimental therapeutic agents have stimulated further interest in much earlier radiation-agent studies to increase the likelihood of success in phase III trials. To sustain this interest, more forward-thinking preclinical radiobiology experimental designs are needed to improve discovery of promising radiochemotherapy plus agent combinations for clinical trial testing. These experimental designs should better inform next-step radiation-agent clinical trial dose, schedule, exposure, and therapeutic effect. Recognizing the need for a better strategy to develop preclinical data supporting radiation-agent phase I or II trials, the National Cancer Institute (NCI)-Cancer Therapy Evaluation Program (CTEP) and the NCI-Molecular Radiation Therapeutics Branch of the Radiation Research Program have partnered to promote earlier radiobiology studies of CTEP portfolio agents. In this Seminars in Radiation Oncology article, four key components of this effort are discussed. First, we outline steps for accessing CTEP agents for preclinical testing. Second, we propose radiobiology studies that facilitate transition from preclinical testing to early phase trial activation. Third, we navigate steps that walk through CTEP agent strategic development paths available for radiation-agent testing. Fourth, we highlight a new NCI-sponsored cooperative agreement grant supporting in vitro and in vivo radiation-CTEP agent testing that informs early phase trial designs. Throughout the article, we include contemporary examples of successful radiation-agent development initiatives.
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The Cancer Therapy Evaluation Program’s (CTEP) implementation of the Operational Efficiency Working Group (OEWG) recommendations.
Journal of Clinical Oncology, 2011Co-Authors: Kate Dipiazza, James A. Zwiebel, Shanda Finnigan, Erin Souhan, Andrea Denicoff, Steve Friedman, Mike Montello, Margaret Mooney, P. Schettino, James H. DoroshowAbstract:6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitte...
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the cancer therapy evaluation program s CTEP implementation of the operational efficiency working group oewg recommendations
Journal of Clinical Oncology, 2011Co-Authors: Kate Dipiazza, James A. Zwiebel, Shanda Finnigan, Erin Souhan, Andrea Denicoff, Steve Friedman, Mike Montello, Margaret Mooney, P. Schettino, James H. DoroshowAbstract:6113 Background: In March 2010, the OEWG recommended strategies to decrease the activation time for NCI-sponsored clinical trials. A major element of the recommendations was the establishment of target timelines (210 days for phase I and II, 300 days for phase III) and absolute deadlines (540 days for phase I and II, 730 days for phase III) for studies to go from study submission to trial activation (i.e., open for patient enrollment). In response to the OEWG recommendations CTEP established new policies and procedures to streamline the protocol development process. Methods: CTEP hired Project Managers to track studies from submission through activation, developed a secure website to allow investigators real-time milestone monitoring, and instituted routine conference calls between CTEP reviewers and investigators at key timeline points to quickly resolve issues and decrease revisions. Also, CTEP’s enforcement of the absolute deadlines began on 1/1/11. Results: Since 4/1/10, 161 studies have been submitte...