This is a question most frequently asked when designing an Enrollment plan for clinical trials, and determining the answer without analytics to help may be a daunting task for sure.
Before we dive too deeply into the solution, lets figure out what we are trying to solve for.
Clinical trials ultimately aim to answer two simple questions:
This can take decades and cost astronomical amounts…take the case of Tamoxifen for Breast Cancer
A clinical trial started in January of 1994 and is projected to complete only in September of 2024 being conducted by the UK’s Queen Mary University of London.
The trial enrolled an astonishing 7,154 women aged 35-70 years across nine countries to investigate if tamoxifen, a hormonal drug, can prevent the development of breast cancer in high-risk women.
And herein lies the opportunity.
Answer: Simply by using the analytics that is embedded in the SAS® Clinical Enrollment Simulation product to create your Enrollment Plans for your clinical trial.
But it will be daunting and complex to build an executable enrollment strategy. The factors used as input are myriad and complex.
The graphic below details the factors that is typically considered when building a representative and executable Enrollment Plan.
Select any image to see a larger version.
Mobile users: To view the images, select the "Full" version at the bottom of the page.
These factors are the things that, when manipulated and fine tuned just the right amount, ensure that your Enrollment Plan is on budget and in time.
Some estimations from Statista.com put the cost per clinical trial participant at upwards of $30,000. Dependent on the clinical trial that is. The graphic below shows some clinical trial costs running into the multiple hundreds of thousands dollars. Phew!.
That means that if we take the lowest cost of $30,000 per patient, the Tamoxifen Breast Cancer study mentioned in the opening has cost 7,154 times $30,000, so $215 odd hundred million so far. That is not a number, it is a SOUND... something like aaaaaaaghhhhhh!.
There are two approaches ways to manipulate the factors that drives the success of a Enrollment Plan. Hint: only one of them is flexible and simple.
Key challenges from the traditional approach:
SAS® Clinical Enrollment Simulation can accurately simulate and model the complex variabilities and probabilities associated with enrolling subjects in clinical trials, including country and site selection using analytics.
The three main benefits of using the SAS solution for running your Clinical Enrollment are detailed in the three graphics below.
The SAS Enrollment Simulator allow you to calculate the chance of success - what I really want to know is “am I going to hit my targets.”
Simulation allows you specify what targets matter, then we can look at what we know about the sites and see how likely we are to achieve the study goals.
The SAS Enrollment Simulator allow you to compare various scenarios with the Milestone achievement capability.
This allows us to see ‘what happens if’. We can play with different scenarios to give us the biggest likelihood of achieving success in our clinical trial.
The SAS Enrollment Simulator allow you to intervene at any time and play out scenarios for intervention when you need to ‘rescue’ a clinical trial site.
For instance, in this scenario we can see that by adding two extra ‘rescue sites’ bumps my chances of getting back on target to 75% and adding three to 95%.
This allow me to make a business decision to see whether spending the money will help me be successful or not, and by what percentage point.
Join us for SAS Innovate 2025, our biggest and most exciting global event of the year, in Orlando, FL, from May 6-9. Sign up by March 14 for just $795.
Data Literacy is for all, even absolute beginners. Jump on board with this free e-learning and boost your career prospects.