On-Demand Webinar

A Guide to Projecting How Long Your Trial Will Take

A Guide to Projecting How Long Your Trial Will Take
2:08
Download and explore the data featured in this webinar:
  • Blinded Subject Level.nqt
  • Blinded Subject Level PCW POI Accrual.nqt
  • Blinded Site And Subject.nqt
  • Unblinded Site And Subject.nqt
  • Unblinded Site And Subject WeibullEvents.nqt

Webinar Playback:

Projecting How Long Your Trial Will Take

In this tutorial, Paul Murphy, research statistician at nQuery, will explore the key factors that influence clinical trial duration, focusing on common milestones that affect study length and the role of simulation modeling in predicting timelines. 

Learning objectives of this webinar:

This webinar will explore key factors affecting clinical trial timelines, including enrollment rates and event milestones. You’ll learn how simulation modeling enhances trial planning, helping to anticipate challenges and optimize efficiency. Using real-world examples, we’ll demonstrate strategies to keep trials on schedule with tools like nQuery Predict.

Four key areas are covered:

1. Understanding Trial Duration Milestones

  • Key factors influencing clinical trial timelines
  • Enrollment rates and event milestones in survival trials
  • Challenges in predicting study length
  • railPractical considerations for accurate projections

2. Simulation Modeling for Enrollment Projections

  • Traditional vs. modern approaches to enrollment forecasting
  • Impact of site activation, recruitment strategies, and dropout rates
  • Scenario analysis for optimizing enrollment efficiency
  • Real-world applications using simulation tools

3. Simulation Modeling for Survival Event Predictions

  • Time-to-event data modeling techniques
  • Hazard rates, treatment effects, and censoring considerations
  • Estimating time to key trial milestones
  • Practical case studies and implementation strategies

4. Enhancing Trial Efficiency with nQuery Predict

  • Adaptive strategies for real-time trial updates
  • Integrating simulation models into trial planning
  • Case examples demonstrating improved trial management
  • Best practices for mitigating potential delays

Projecting How Long Your Trial Will Take: A Quick Guide for Biostatisticians

Understanding Statistical Intervals in Modern Clinical Research

The simulation modeling is a highly flexible way to predict how long it will take to reach a trial milestone. Whether pre-trial or using interim data, simulation tools such as nQuery Predict can help better understand the trajectory of your trial allowing for early warning and potential adaptation if a trial is falling behind schedule. 

This tutorial covers an overview of enrollment and survival events prediction for clinical trials. We explore how simulations can be tailored to model the enrollment process, the factors influencing enrollment and how they can be incorporated into simulations.

Understanding Key Milestones in Trial Duration

The duration of a clinical trial is influenced by several key milestones, with enrollment rates and event occurrences being two of the most critical. Accurately forecasting these milestones allows for more efficient trial design and resource allocation. In this section, we’ll explore how factors like recruitment rates, patient screening, and dropout rates can affect the overall timeline of a trial. Understanding these milestones is essential for predicting study completion and making timely adjustments during the trial.

Simulation Modeling for Enrollment Projections

Effective trial planning requires accurate projections of how long it will take to enroll patients. Traditional enrollment forecasting methods often rely on simple projections, but modern techniques—such as simulation modeling—allow for more dynamic and accurate predictions. In this section, we’ll cover the latest approaches to predicting enrollment timelines, including how site activation, recruitment strategies, and patient dropout rates impact trial duration. We’ll also demonstrate how to use simulation tools like nQuery Predict to create more realistic enrollment forecasts, helping you to plan more effectively.

Simulation Modeling for Survival Event Predictions

Beyond enrollment, a key factor affecting trial duration is the timing of survival events. These events are integral to measuring treatment efficacy and evaluating trial outcomes. In this section, we’ll delve into how time-to-event data is used to predict survival milestones, and how factors such as hazard rates, treatment effects, and censoring influence event timelines. We’ll explore how simulation modeling can be used to predict these milestones with greater accuracy, ensuring that trial timelines are as realistic as possible.

Enhancing Trial Efficiency with nQuery Predict

Modern simulation tools like nQuery Predict provide researchers with the power to adapt and adjust trial projections in real-time. These tools allow for the integration of complex models, providing accurate predictions of trial duration, even in the face of unpredictable variables like enrollment rates and survival events. This section will explore how adaptive strategies, facilitated by tools like nQuery Predict, can enhance trial efficiency. We will demonstrate how simulation models can be integrated into your planning process, with real-world case studies showing how to optimize trial management and avoid common delays.


About nQuery
nQuery helps make your clinical trials faster, less costly and more successful.
It is an end-to-end platform covering Frequentist, Bayesian, and Adaptive designs with 1000+ sample size procedures. 

nQuery Solutions
Sample Size & Power Calculations
Calculate for a Variety of frequentist and Bayesian Design

Adaptive Design
Design and Analyze a Wide Range of Adaptive Designs

Milestone Prediction
Predict Interim Analysis Timing or Study Length

Randomization Lists
Generate and Save Lists for your Trial Design

 

Who is this for?

This will be highly beneficial if you're a biostatistician, scientist, or clinical trial professional that is involved in sample size calculation and the optimization of clinical trials in:

 

  • Pharma and Biotech
  • CROs
  • Med Device
  • Research Institutes
  • Regulatory Bodies
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