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    • What makes rare disease clinical trials successful?
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What makes rare disease clinical trials successful?

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies.

Since its founding in 1992, Alexion has given hope to people who had none and shined a light on those who felt isolated and alone. But we know that fighting rare diseases takes so much more than hope. It requires persistence, dedication, and a relentless pursuit of the highest levels of medical innovation. At Alexion, our goal is to deliver medical breakthroughs where none currently exist. We are driven because we know people’s lives are at stake.

Through the transformative power of our science, Alexion has delivered life-changing therapies to patients suffering from rare diseases. We have pioneered the complex field of complement biology and delivered solutions to challenges that once seemed impossible for patients with devastating complement-mediated and metabolic disorders.

The Alexion Challenge

Start your analysis with the first question below and add at least one more of the remaining questions.

  1. Which rare diseases had the most trials?
  2. How does sampling effect trial success?
    Tip: Sampling typically includes variables such as: age, gender, locations (single location vs. multi-center), and enrollment size.
  3. Are trials with single funding sources such as (private or public only) vs. combined funding sources (multiple private companies or private and public) more successful?
  4. Can you identify future trends in clinical trials?
    Tip: Use articles, blogs, published studies, and other external sources to support your claims.
  5. For trials that went on to get drug approval, which intervention types such as drug, biologic, genetic, or behavioral had the shortest time to approval? Why?

Datasets:

Note: you will need to open the data file on your computer with excel-excel online will not work

Click here for Alexion Data

Click here for Alexion Data Dictionary

About rare diseases and clinical trials

Rare disease has a different definition throughout the world. Any disease or disorder bearing some serious life-threatening conditions that affect 1 in 2000 individuals in Europe or fewer than 200,000 individuals in the United States are labeled as ‘rare’. Moreover, clinical trials are experiments or observations conducted that are pertinent to gather medical knowledge and are helpful to determine whether a medical surgery, a drug or a device is safe to use or consume by humans.

Important: You should explicitly define and quantify what a “successful trial” is.  Think from both scientific and monetization perspectives.

For more information:

https://clinicaltrials.gov/ct2/resources/trends#MapOfStudies.

https://americansforcures.org/whiteboard_video/video-how-clinical-trials-work/

All data came from the clinicaltrials.gov website.

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