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ABSTRACT

Planning patient enrolment is a major challenge for a successful clinical trial. One of the major reasons for trial failure is inability to meet targeted patient enrolment. Pharmaceutical companies are facing overrun for unacceptable cost and time in conducting clinical trials due to several uncertainties and complexities involved in the enrolment process.

Dependable and more efficient trial planning requires projection of many important aspects like number of sites, their start up time, enrolment rates in certain time period. It also needs decision rules driven by event triggers using appropriate methodology which considers the operational complexities.

EnForeSys® is an enrolment forecasting tool. We will demonstrate how EnForeSys uses the power of Monte Carlo simulations to model the effects of various parameter variations and risks on the recruitment process. It helps in efficient planning of a trial to achieve the expected enrolments within acceptable duration, thus fast tracking the approval process.

SUMMARY

According to a paper, Impact Report Tufts CSDD, 2013, the most common cause for incomplete Phase 3 trials is related to enrolment. This is not surprising when as many as 37% of trial sites miss enrolment targets, and 11% fail to enroll a single patient.

A vast majority of clinical trials experience delays in enrolment, and in the worst cases, these delays lead to discontinued trials. Even for successful trials, however, enrolment delays impose a substantial cost on the sponsor by increasing clinical operations expenses and loss of revenue due to delayed submissions. On the other hand, over-enrolling patients can also waste resources. Thus, optimal planning of patient enrolment – a key component of trial success - remains a difficult balancing act.

EnForeSys is designed to overcome the challenges which are faced by pharmaceutical companies in meeting the enrolment targets of the clinical trials. It uses simulations to calculate numerical probability of success for all of our strategies. EnForeSys helps to estimate the trial duration using site and recruitment specific information. EnForeSys can be used to compute the expected trial duration for achieving a specified target and on the other hand it can be used to compute required accrual rates to achieve the target in a specified time period. EnForeSys assists in planning and execution of clinical trials by:

  1. Predicting subject enrolment and site initiation based on known probability distributions
  2. Measuring and analysing site performance
  3. Estimating the probability of achieving milestones
  4. Enrolment timeline validation

We would be demonstrating following important features of EnForeSys which makes it easier to use, efficient and user friendly:

Interim Analysis:

It provides option to perform Interim Analysis during simulations and allows user to accommodate the slowdown of accrual process during this period.

Considers Realistic Problems:

EnForeSys deals with realistic problems like site and screen failure. It accepts inputs for site failure and screen failure probabilities from user and uses it for better estimation. The estimated trial duration also accounts for the required screening duration.

Probability distribution for Input Parameters:

Using historical data or with previous experience; study managers can come up with probability distributions for various site and recruitment specific parameters. EnForeSys allows such experienced users to use those distribution parameter for simulation. User can save those distributions in global or local settings and need not change those unless and until required.

Specify Milestones:

User can perform analysis at different milestones during simulations. Milestones based on different criteria like elapsed time from trial start or number of subjects accrued can be set.

Usability Features:

EnForeSys has feature of importing parameters from CSV files to provide faster inputs. This would help user to provide inputs easily mainly in case where more number of regions and sites are involved in the enrolment process. Some of other usability features like “Plots & Tables” and “View & Hide Outputs” etc. are provided by EnForeSys for facilitating input process and making outputs more interpretable.

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