BioCentury and Advarra, the market leader in regulatory reviews and a leading provider of clinical research technology, are conducting this survey to better understand the operational realities of conducting cancer trials by capturing insights directly from sponsors and CROs. Findings will be anonymized and synthesized into a report to help the research community identify inefficiencies, benchmark performance, and uncover actionable opportunities to reduce friction and improve trial execution. We are looking for responses from those involved in the management and operations of cancer trials.

Your responses are anonymous and will be reported in aggregate. The results of the survey will be published in BioCentury.

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* What type of organization do you represent? 

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* How many oncology trials has your organization conducted in the past 2 years?

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* What phase were these trials? (check all that apply)

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* What are the most important factors in selecting sites? (Select up to 3)

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* How often do your clinical trials sites meet enrollment targets?

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* In your experience, which protocol elements have created operational burden for oncology trials? (Select up to three)

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* FDA’s Project Optimus is a program to reform the dose optimization and selection process in cancer trials. Please rank your agreement or disagreement with the following statements. If you are not familiar with Project Optimus or have not incorporated it into your trials, please select “N/A” for all.

  Agree Neutral Disagree N/A
Project Optimus has increased the size requirements for my trials 
Project Optimus has increased the complexity of my trial designs 
Project Optimus has led to dropped trials due to changing cost/time/design structures 
Project Optimus has improved the quality of my data/increased chances of success in later-stage trials

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* How often are inclusion/exclusion criteria adjusted during an ongoing trial?  

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* Have you ever delayed database lock due to data quality concerns?

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* How often are protocol amendments implemented in an ongoing trial?  

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* How long does it take, on average, to implement a protocol amendment from the time you decide an amendment is necessary to when it has been implemented at all sites?

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* What strategies and technologies have reduced your trial costs in the past 12 months? (Pick up to 3)

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* Do you feel your current oncology trial budgets are sufficient for scientific and operational integrity?

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* Which of the following Institutional Review Boards (IRBs) do you use for your oncology clinical trials? (Select all that apply)

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* Of the IRBs listed in the previous question, which IRB do you prefer for oncology clinical trials? Address timeliness of review, quality of review, cost (if any), submission requirements and any other related comments.

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