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  ["project_title"]=>
  string(85) "Understanding reasons for screen failures in late phase trials in advanced GU cancers"
  ["project_narrative_summary"]=>
  string(623) "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."
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    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
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      string(19) "2014-10-20 14:57:00"
      ["post_date_gmt"]=>
      string(19) "2014-10-20 14:57:00"
      ["post_content"]=>
      string(0) ""
      ["post_title"]=>
      string(233) "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"
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  ["property_scientific_abstract"]=>
  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.

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."
  ["project_brief_bg"]=>
  string(554) "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."
  ["project_specific_aims"]=>
  string(319) "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."
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  }
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  ["project_research_methods"]=>
  string(151) "Retrospective analyses of the COU 301  clinical trial will be conducted to assess for screen failures, and reasons for screen failures where available."
  ["project_main_outcome_measure"]=>
  string(280) "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."
  ["project_main_predictor_indep"]=>
  string(158) "Evaluate the predictors of screen failures using univariate and multivariate binary logistic regression analysis if possible only depending on data available."
  ["project_other_variables_interest"]=>
  string(72) "We will also be interested in determining the timing of screen failures."
  ["project_stat_analysis_plan"]=>
  string(564) "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."
  ["project_timeline"]=>
  string(295) "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"
  ["project_dissemination_plan"]=>
  string(145) "Circulation of abstract targeting ASCO  to YODA 12/2015

Circulation of paper to YODA targeting JCO, Lancet Oncology, or Journal of Urology"
  ["project_bibliography"]=>
  string(480) "
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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  ["project_status"]=>
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  ["project_year_access"]=>
  string(4) "2015"
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        ["title"]=>
        string(102) "Project Summary: Understanding reasons for screen failures in late phase trials in advanced GU cancers"
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pi country
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pi affil
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products
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