Decoration

Case Study: Feasibility Analysis with Spectrum for Top-10 Pharma

News provided:

July 31, 2024, 9:12 AM EDT

BMS Case Study - Blog Post

________________________________________________________________________________________________________

In our recent deep dive into the clinical trial processes of top-10 pharmaceutical companies, we discovered something eye-opening: traditional site selection methods and feasibility processes are not only outdated but are also significantly impacting trial success rates.

 

Here’s the case-study:

Before the advent of advanced AI tools like Spectrum™, pharma companies primarily relied on manual processes and a biased US-centric approach for their trial sites. This method, while seemingly logical due to regulatory and operational conveniences, posed severe risks of over-concentration and inefficiency that ultimately leads to delays and other trial challenges.

 

We might wonder, why do we stick to this model?

BMS Case Study-01-01

But with Spectrum, this game has changed.

 

The Challenge

A top-10 pharmaceutical Sponsor faced a daunting task: identify the most suitable sites for a critical phase III Obstructive Hypertrophic Cardiomyopathy(oHCM) trial.

With a target of 500 participants spread across 250 sites, a 730-day enrollment window, and a 365-day site activation period, the stakes were high. Traditional methods left them heavily reliant on US sites, which posed significant risks, including over-concentration and extended timelines.

The Analysis

Spectrum completed a comprehensive, data-driven feasibility analysis and leveraged cutting-edge AI to create two distinct scenarios:

BMS Case Study-02-1

The Execution

Our machine learning model didn’t just skim the surface; it dove deep into both proprietary and public historical data, predicting trial timelines with remarkable precision. This endeavor was not just about crunching numbers but about harnessing the power of Real-World Data (RWD) and machine learning to transform clinical trial operations. Here’s what we found:

BMS Case Study-03-1The Impact

The results were both clear, and compelling:

BMS Case Study-04

By integrating Spectrum’s AI-driven insights, this study sponsor didn’t just follow the usual path; they blazed a new trail in clinical trial feasibility.