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  string(1145) "Background: Screen failures in clinical trials represent a significant cost and resource expenditure. Understanding the reasons behind screen failures and developing strategies to minimize them, could significantly improve efficiency and reduce the costs of doing clinical trials.
Objective: To review published phase III trials in advanced prostate cancer and collect data on number and timing of screen failures as well as document reasons for screen failures where available.
Study Design: Retrospective cohort study
Participants: All patients enrolled on the COU 301 study, with a specific focus on those patients who were deemed to be screen failures.
Main Outcome Measures:
1. The number (percent) of screen failures.
2. The specific reasons for screen failures - identifying if they are are study or patient related.
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Obtain Deidentified Dataset - 10/2015
Analysis and preliminary report submitted to YODA 12/2015
Circulation of abstract targeting ASCO to YODA 12/2015
Circulation of paper to YODA targeting JCO, Lancet Oncology, or Journal of Urology" ["project_dissemination_plan"]=> string(145) "Circulation of abstract targeting ASCO to YODA 12/2015
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1) McKane et al., Determinants of patient screen failures in Phase 1 clinical trials.
Invest New Drugs. 2013 Jun;31(3):774-9. doi: 10.1007/s10637-012-9894-7. Epub 2012 Nov
de Bono J et al
2) Abiraterone and increased survival in metastatic prostate cancer
N Engl J Med. 2011 May 26;364(21):1995-2005
3) Ryan CJ et al
Abiraterone in metastatic prostate cancer without previous chemotherapy.
N Engl J Med. 2013 Jan 10;368(2):138-48.

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2015-0565

General Information

How did you learn about the YODA Project?: Data Holder (Company)

Conflict of Interest

Request Clinical Trials

Associated Trial(s):
  1. NCT00638690 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
What type of data are you looking for?: Individual Participant-Level Data, which includes Full CSR and all supporting documentation

Request Clinical Trials

Data Request Status

Status: Concluded

Research Proposal

Project Title: Understanding reasons for screen failures in late phase trials in advanced GU cancers

Scientific Abstract: Background: Screen failures in clinical trials represent a significant cost and resource expenditure. Understanding the reasons behind screen failures and developing strategies to minimize them, could significantly improve efficiency and reduce the costs of doing clinical trials.
Objective: To review published phase III trials in advanced prostate cancer and collect data on number and timing of screen failures as well as document reasons for screen failures where available.
Study Design: Retrospective cohort study
Participants: All patients enrolled on the COU 301 study, with a specific focus on those patients who were deemed to be screen failures.
Main Outcome Measures:
1. The number (percent) of screen failures.
2. The specific reasons for screen failures - identifying if they are are study or patient related.
3. The main predictors of screen failures using univariate and multivariate binary logistic regression analysis.
Statistical Analysis: We will evaluate predictors of screen failures using uni-variate and if possible multivariate binary logistic regression analysis.

Brief Project Background and Statement of Project Significance: Screen failures in late phase clinical trials in GU oncology are not uncommon with rates of about 25%, similar to what has been previously reported for Phase 1 trials by Mckane et al (Investigational New Drugs 2013). Both patient specific and study specific factors may contribute to screen failures. Understanding the reasons behind screen failures and developing strategies to minimize them, may significantly improve efficiency and reduce the cost of doing clinical trials not only in advanced prostate cancer, but widely across the field of oncology.

Specific Aims of the Project: 1. Document the number (percent) of screen failures.
2. Document the specific reasons for screen failures - identifying if they are are study or patient related where possible.
3. Evaluate the predictors of screen failures using univariate and multivariate binary logistic regression analysis if possible.

Study Design:

What is the purpose of the analysis being proposed? Please select all that apply.:

Software Used:

Data Source and Inclusion/Exclusion Criteria to be used to define the patient sample for your study: Retrospective analyses of the COU 301 clinical trial will be conducted to assess for screen failures, and reasons for screen failures where available.

Primary and Secondary Outcome Measure(s) and how they will be categorized/defined for your study: 1. Document the number (percent) of screen failures.
2. Document the specific reasons for screen failures - where this data is available.
3. Evaluate the predictors of screen failures using univariate and multivariate binary logistic regression analysis if possible.

Main Predictor/Independent Variable and how it will be categorized/defined for your study: Evaluate the predictors of screen failures using univariate and multivariate binary logistic regression analysis if possible only depending on data available.

Other Variables of Interest that will be used in your analysis and how they will be categorized/defined for your study: We will also be interested in determining the timing of screen failures.

Statistical Analysis Plan: Results will be analyzed primarily using descriptive analyses.
The predictors of screen failures will be analyzed using univariate and multivariate binary logistic regression analysis if at all possible and if only if data permits.
Information to be collected where possible includes: potential reasons for screen failure and/or whether there was withdrawal of consent.
We will also collect the date of visit for screened participants to determine if there were more screen failures occurring earlier or later during the conduct of the study.

Narrative Summary: In clinical trials, screen failures are defined as subjects who consented to participate in research but who were disqualified during screening procedures. Screen failures can occur for patient or study specific reasons and can significantly increase the resource requirements and costs of doing clinical trials. The goal of this project is to better understand why screen failures occur in late phase clinical trials in advanced genitourinary cancers (prostate, kidney and bladder cancer). Understanding screen failures could lead to better trial design in GU oncology that aims to limit the potential for screen failures.

Project Timeline: Completion of Contract - 10/2015
Obtain Deidentified Dataset - 10/2015
Analysis and preliminary report submitted to YODA 12/2015
Circulation of abstract targeting ASCO to YODA 12/2015
Circulation of paper to YODA targeting JCO, Lancet Oncology, or Journal of Urology

Dissemination Plan: Circulation of abstract targeting ASCO to YODA 12/2015
Circulation of paper to YODA targeting JCO, Lancet Oncology, or Journal of Urology

Bibliography:

1) McKane et al., Determinants of patient screen failures in Phase 1 clinical trials.
Invest New Drugs. 2013 Jun;31(3):774-9. doi: 10.1007/s10637-012-9894-7. Epub 2012 Nov
de Bono J et al
2) Abiraterone and increased survival in metastatic prostate cancer
N Engl J Med. 2011 May 26;364(21):1995-2005
3) Ryan CJ et al
Abiraterone in metastatic prostate cancer without previous chemotherapy.
N Engl J Med. 2013 Jan 10;368(2):138-48.