Finding new answers in old data

Biogen builds one of the world’s largest databases in MS using over two decades’ worth of clinical trial data

By Ih Chang
Senior Director, Biostatistics

May 23, 2017

Over the past thirty years, Biogen has developed a spectrum of disease-modifying therapies for the treatment of multiple sclerosis (MS). In order to gain regulatory approval, each of these therapies was rigorously tested using double blind, randomized, controlled clinical trials. Thousands of patients’ data were collected throughout these trials using robust protocols of the day.

Indeed, those data served a vital purpose — to provide evidence of the therapies’ safety and effectiveness. But rather than relegating them to a dusty old shelf, our team here at Biogen realized they could be an enormously valuable treasure trove to further understand the disease courses of MS patients, determine the characteristics of sub-populations, define new endpoints to assess different types of treatment, and answer many other scientific and clinical questions.    

If you build it…
As we sorted through the clinical trial data in our archives, we realized we had unearthed a mountain of information — spanning over 20 years and more than 8,000 patients. Integrating and harmonizing this large volume of patient information was no trivial task. A rigorous process was put in place in the building of this integrated database to ensure that it provides efficient and easy access to high a quantity of anonymized individual patient level data as well as assure high data quality.

We began building this MS database about three years ago. And though work still continues — and will continue further as we pursue future clinical trials — the database has matured to an advanced stage, and can be and has been queried by researchers here at Biogen for many important questions regarding MS patients and treatments.

Putting the MS database to work
One of the first questions Biogen scientists researched was: What are the baseline characteristics in placebo-treated MS patients and are there features that can help predict patients’ long-term disability? Determining which patients with MS will go on to develop severe disease and which ones will not progress as severely remains one of the biggest challenges in MS diagnosis. Finding predictors of disease progression is a top priority.

Another example of key areas that our database is aspiring to is to identify types of early treatment that may have potential long-term benefit to patients such as delaying the need for walking aids or wheelchairs and/or slowing the deterioration of other critical functions.

By tackling these questions, and others, we are bringing new life to our old data and, at the same time, helping to research some of the toughest problems in MS patient care.

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