Funding of biomarker, imaging, quality-of-life (QOL), and cost-effectiveness analysis (CEA) studies by NCI.

2012 ◽  
Vol 30 (30_suppl) ◽  
pp. 104-104
Author(s):  
Ray A. Petryshyn ◽  
Geoffrey David Seidel ◽  
Sheila Ann Prindiville
Keyword(s):  
Clinical Trial ◽  
Treatment Effectiveness ◽  
Phase Iii ◽  
Standards Of Care ◽  
Cooperative Groups ◽  
Specimen Collection ◽  
Randomized Phase Ii ◽  
Funding Program ◽  
Integrated Studies ◽  
Clinical Trial Accrual

104 Background: NCI’s purpose for the Biomarker, Imaging, and QOL Studies Funding Program (BIQSFP) is to ensure that the most important, scientifically meritorious biomarker, imaging, QOL, and/or CEA studies can be initiated in a timely manner in association with NCI clinical trials. BIQSFP studies are embedded in selected large, randomized phase II treatment trial concepts with a control arm and an integral study(ies), along with integral and/or integrated studies associated with phase III treatment trials, cancer prevention trials, and primary symptom management trials. Methods: BIQSFP provides opportunities to enhance clinical outcomes by validating targets, reducing morbidity, predicting treatment effectiveness, identifying populations that may better benefit from treatment, improving clinical trial accrual and retention, and modifying standards of care. BIQSFP applications are accepted from NCI Cooperative Groups and Community Clinical Oncology Programs. Integral components must be performed in order for the trial to proceed. Integral studies have the highest funding priority. Integrated components are clearly identified as part of the clinical trial from the beginning, are intended to identify or validate (in the patient population of interest) assays/tests/QOL tools that are planned for use in future trials, are performed in real time, and include complete plans for specimen collection, laboratory measurements, and statistical analysis. Integrated studies in general should not be exploratory but rather should be designed to test a hypothesis, not simply to generate hypotheses. Results: Since 2009, 36 BIQSFP funding applications have been reviewed with most evaluations via NCI’s Scientific Steering Committees (http://ccct.cancer.gov/). Twenty studies have been approved for BIQSFP funding. Conclusions: BIQSFP information presented in the poster includes scope of activity, process for application and evaluation, and funded projects (http://biqsfp.cancer.gov/). Funded by NCI Contract No. HHSN261200800001E.

scholarly journals Barriers to accrual and enrollment in brain tumor trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 2024-2024 ◽  
Author(s):  
Eudocia Quant Lee ◽  
Ugonma Nnenna Chukwueke ◽  
Shawn L. Hervey-Jumper ◽  
John Frederick De Groot ◽  
Jose Pablo Leone ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Response Assessment ◽  
Patient Advocacy ◽  
Cooperative Groups ◽  
Advocacy Groups ◽  
Oncology Patient ◽  
Clinical Trial Accrual ◽  
Multi Stakeholder ◽  
Patient Advocacy Groups ◽  
Major Impediment

2024 Background: A major impediment to improving neuro-oncology outcomes is poor clinical trial accrual. Methods: We convened a multi-stakeholder group including Society for Neuro-Oncology, Response Assessment in Neuro-Oncology, patient advocacy groups, clinical trial cooperative groups, and other partners to determine how we can improve trial accrual. Results: We describe selected factors contributing to poor trial accrual and possible solutions. Conclusions: We will implement strategies with the intent to double trial accrual over the next 5 years. [Table: see text]

Cancer clinical trial accrual patterns among community cancer centers in the United States

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6041-6041
Author(s):  
J. A. Lee ◽  
M. A. Mathiason ◽  
C. A. Czeczok ◽  
J. K. Keller ◽  
R. S. Go
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Cancer Patients ◽  
The United States ◽  
Cooperative Groups ◽  
Medical Support ◽  
Cancer Centers ◽  
Number Of Patients ◽  
Clinical Trial Accrual ◽  
The U.S

6041 Background: Most cancer patients are diagnosed and treated in the community but clinical trial accrual rate is low. Published data on trial accrual from community-based cancer centers throughout the U.S. are limited. The Association of Community Cancer Centers (ACCC) is a national multidisciplinary education and advocacy organization that maintains a membership caring for over 60% of all patients with cancer in the U.S. In order to determine the clinical trial accrual patterns in the community across various geographic regions in the U.S., we performed a retrospective study utilizing the data from ACCC membership maintained at their web site. Methods: Data available from the most recent year (2003–2005) were obtained from 621 centers throughout the U.S., representing 49 states (no data for WY) and the DC. We investigated the number of patients (new and old) accrued into trials per year relative to the number of new analytical patients seen in the same year, a value we termed accrual ratio (AR). In addition, we studied the effects of geographic location, size of the cancer program, number of affiliations with National Cancer Institute sponsored cancer cooperative groups, and the number of medical/support/data management staffs on trial accrual. Results: A total of 670,215 new patients were seen across the ACCC membership with 43,743 patients accrued into trials for a median AR of 6.5% (range, 0.3–16.9). The top and bottom 5 accruing states were VT, MD, SD, LA, ID and KS, ND, VA, NH, AR, respectively. Regionally, the AR for Midwest, Middle Atlantic, West, South, Southwest, and New England were as follows: 7.4%, 7.0%, 6.2%, 6.0%, 5.7%, and 5.4% (p < 0.001). One hundred (16.1%) centers representing 11.8% of all new patients were not affiliated with any of the cooperative groups. This group had the lowest AR (3.1%). AR increased when centers were affiliated with more cooperative groups (p < 0.001) or cared for more new patients (p < 0.001). The number of medical, support, and data management staffs did not influence accrual. Conclusions: Overall, clinical trial accrual in the U.S. community cancer centers is low. Accrual patterns differed significantly among various geographic locations. Better access to trials is needed in order to improve participation of cancer patients. No significant financial relationships to disclose.

Impact of direct physician-to-physician contact on accelerating oncology clinical trial accrual

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6613-6613
Author(s):  
J. R. Eckardt ◽  
N. Ku ◽  
A. DeMaggio ◽  
M. Reese ◽  
M. Levonyak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Current Model ◽  
Phase Iii ◽  
Initial Assessment ◽  
Phase Ii Trials ◽  
Physician Intervention ◽  
Physician Contact ◽  
Clinical Trial Accrual ◽  
Physician Awareness

6613 Background: The development of more effective oncology agents is critically dependent on the completion of clinical trials; currently, >4000 oncology trials listed in www.clinicaltrials.gov are accruing pts in the US. Unfortunately, only 3–5% of new cancer pts participate in clinical trials and most trials do not meet their projected accrual timelines. Barriers to pt accrual include physician awareness & attitudes, access to protocols, administrative burdens to conduct clinical trials, cost to physicians and pts, and pt concerns about participation in research trials. To overcome at least some of these barriers, we investigated a strategy to improve clinical trial accrual that optimizes trial placement and awareness through a direct physician to physician intervention. Methods: For each site, a customized enrollment plan is established after initial assessment of interest and accrual potential. Implementation of the enrollment plan includes clinical communications and medical support delivered through direct physician to physician interactions. From Feb 2008 to December 2008, we implemented this strategy to increase accrual to 5 oncology trials (2 placebo controlled randomized trials and 3 phase II trials in breast cancer, non-Hodgkin's lymphoma and soft tissue sarcoma). Results: The implementation of direct physician to physician intervention resulted in a measurable improvement of between 50 - 300% in the monthly accrual to each of these 5 trials. Despite being significantly behind projections, 2 of the trials have now completed accrual on schedule. In the ongoing phase III study, accrual has improved from an average of 3.8 pts/mo to 13.5 pts/mo. Conclusions: The use of our current model of optimizing trial placement and awareness through a direct physician to physician intervention has been successful in significantly accelerating clinical trial accrual in 5/5 trials initiated to date. [Table: see text] [Table: see text]

A randomized phase II/III study comparing stereotactic body radiotherapy (SBRT) versus conventional palliative radiotherapy (CRT) for patients with spinal metastases (NCT02512965).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS10129-TPS10129 ◽  
Author(s):  
Arjun Sahgal ◽  
Sten Myrehaug ◽  
Kristopher Dennis ◽  
Mitchell Liu ◽  
Edward Chow ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Stereotactic Body Radiotherapy ◽  
Spinal Metastases ◽  
Drop Out ◽  
Phase Iii ◽  
Pain Response ◽  
Conventional Radiotherapy ◽  
Randomized Phase Ii ◽  
Phase Iii Study

TPS10129 Background: Innovative radiotherapy technology and modern imaging capabilities enable the use of Stereotactic Body Radiotherapy (SBRT) to treat patients with spinal metastases to optimize tumour control and palliation compared to standard conventional radiotherapy. No randomized clinical trial evidence exists directly comparing the two treatment strategies. Methods: SC.24 is a Canadian Cancer Trials Group randomized phase II/III study comparing standard conventional radiotherapy (20 Gy/5fr) to SBRT (24 Gy/2fr) in patients with solid tumours and MRI documented, painful spinal metastases suitable for RT. The primary accrual objective for the phase II portion of the study was met in January 2017 and the study continues as a randomized phase III study with a primary outcome measure of complete pain response at 3 months post radiotherapy. Secondary objectives include: measurement of complete pain response at 6 months; radiation site progression free survival at 3 and 6 months; adverse event profile, health related QOL and compliance with RT QA measures. Biobanking for future correlative studies is included in study design. Statistical design: The statistical assumptions for the phase III study include estimated complete pain response rates of 10% and 30% for the CRT and SBRT treatment arms respectively. Using a two sided alpha = 0.05 and power = 80% the sample size for the phase III study is 152, taking into account a 5% drop out rate. Conduct to Date: Study activation: July 2015. Accrual to date: 58. Supported by CCSRI grant 021039 Clinical trial information: NCT02512965.

S1406: Randomized phase II study of irinotecan and cetuximab with or without vemurafenib in BRAF-mutant metastatic colorectal cancer (mCRC).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. TPS790-TPS790 ◽  
Author(s):  
Scott Kopetz ◽  
Shannon McDonough ◽  
Van Karlyle Morris ◽  
Heinz-Josef Lenz ◽  
Anthony M. Magliocco ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Metastatic Disease ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Braf Inhibitor ◽  
Treatment Resistance ◽  
Cooperative Groups ◽  
Egfr Inhibition ◽  
Randomized Phase Ii

TPS790 Background: BRAFV600 mutations are associated with inferior survival and objective responses to the mutated BRAF inhibitor vemurafenib in patients with mCRC. Blockade of BRAFV600 by vemurafenib causes feedback upregulation of EGFR, whose signaling activities can be impeded by cetuximab. In murine models of BRAFV600 mCRC, the addition of irinotecan to vemurafenib and cetuximab leads to greater anti-tumor activity. Recent phase I studies with the combination of BRAF and EGFR inhibition resulted in response rates substantially higher than either agent alone, with objective responses in 4 of 8 BRAFV600 mCRC patients treated with vemurafenib, cetuximab, and irinotecan. Methods: The SWOG 1406 trial (NCT 02164916) is a randomized phase II study of irinotecan (180 mg/m2 IV every 14 days) and cetuximab (500 mg/m2 IV every 14 days) with or without vemurafenib (960 mg PO twice daily). Eligible adult patients have histologically confirmed colorectal adenocarcinoma with metastatic disease. Tumors must have a BRAFV600 mutation and be wild-type for KRAS and NRAS. BRAF testing may be conducted using any CLIA-compliant lab. Alternatively, screening can be provided through a central lab. Patients must have received one or two prior systemic regimens for unresectable locally advanced or metastatic disease and must not have received anti-EGFR agents. Prior treatment with irinotecan is allowed. Patients randomized to the control arm may crossover to the experimental arm at progression. Target enrollment is 78 patients. The primary endpoint is PFS. Optional participation in a co-clinical trial will be offered in selected sites whereby patients’ biopsies will be used to establish patient-derived xenografts to study correlations between patient and PDX with respect to treatment responses and mechanisms of treatment resistance. This trial has support from all adult cooperative groups and utilizes the Central IRB to facilitate study initiation. Conclusions: mCRC patients harboring BRAFV600E mutations may benefit from EGFR and BRAF blockade. We encourage screening for the BRAF mutation early in the course of metastatic disease therapy and for second line therapy on this trial. Clinical trial information: NCT 02164916.

scholarly journals Barriers to accrual and enrollment in brain tumor trials

2019 ◽  
Author(s):  
Eudocia Q Lee ◽  
Ugonma N Chukwueke ◽  
Shawn L Hervey-Jumper ◽  
John F de Groot ◽  
Jose Pablo Leone ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Brain Tumor ◽  
Response Assessment ◽  
Adult Brain ◽  
Cooperative Groups ◽  
Tumor Patients ◽  
Cancer Society ◽  
Clinical Trial Accrual ◽  
Patient Advocacy Groups

Abstract Many factors contribute to the poor survival of malignant brain tumor patients, some of which are not easily remedied. However, one contributor to the lack of progress that may be modifiable is poor clinical trial accrual. Surveys of brain tumor patients and neuro-oncology providers suggest that clinicians do a poor job of discussing clinical trials with patients and referring patients for clinical trials. Yet, data from the Cancer Action Network of the American Cancer Society suggest that most eligible oncology patients asked to enroll on a clinical trial will agree to do so. To this end, the Society for Neuro-Oncology (SNO) in collaboration with the Response Assessment in Neuro-Oncology (RANO) Working Group, patient advocacy groups, clinical trial cooperative groups, including the Adult Brain Tumor Consortium (ABTC), and other partners are working together with the intent to double clinical trial accrual over the next 5 years. Here we describe the factors contributing to poor clinical trial accrual in neuro-oncology and offer possible solutions.

scholarly journals INNV-33. BARRIERS TO ACCRUAL AND ENROLLMENT IN BRAIN TUMOR TRIALS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi137-vi137
Author(s):  
Eudocia Lee ◽  
Ugonma Chukwueke ◽  
Shawn Hervey-Jumper ◽  
John DeGroot ◽  
Pablo Leone ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Organizational Factors ◽  
Response Assessment ◽  
Cooperative Groups ◽  
Advocacy Groups ◽  
Oncology Patient ◽  
Community Factors ◽  
Clinical Trial Accrual ◽  
Multi Stakeholder ◽  
Patient Advocacy Groups

Abstract BACKGROUND A major impediment to improving neuro-oncology outcomes is poor clinical trial accrual. METHODS We convened a multi-stakeholder group including Society for Neuro-Oncology, Response Assessment in Neuro-Oncology, patient advocacy groups, clinical trial cooperative groups, and other partners to determine how we can improve trial accrual. RESULTS We described selected factors contributing to poor trial accrual and possible solutions. We focused on patient and community factors, disparities, physician and provider factors, clinical trial factors, and site and organizational factors CONCLUSIONS We will implement strategies with the intent to double accrual to neuro-oncology trials over the next 5 years.

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