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Phase 1 Clinical Trials Are Key Step in Drug-approval Process

Understanding the early steps in the clinical trial process for a new multiple sclerosis medication.

We wait in anticipation for multiple sclerosis (MS) drugs to clear Phase 3 clinical trials and get to the Food and Drug Administration (FDA) for approval, but I honesty knew little of the process that takes place before the large-scale testing of drugs in Phase 3. I was selected to the Drug Industry Association (DIA) Patient Fellows program and attended its DIA 2016 convention in Philadelphia in late June, and learned much about what happens before the FDA receives a drug for approval. I had not given much thought to what Phase 1 for a clinical trial might look like — I just assumed the process involved those of us with a particular condition getting a drug and others passing through Phase 2 and Phase 3 as a treatment meets the necessary benchmarks of showing effectiveness.

Phase 1 trials don’t involve people with the particular disease, such as MS, being tested — these participants are healthy people with clean medical records and in excellent shape.  The trials are designed to make sure the proposed drug is safe for people to take, and there are companies that specialize in doing nothing but assisting with Phase 1 trials. One such company is Celerion, and I had the chance to talk with David Misiak, Celerion’s senior director, Business Development, at DIA 2016.

The company has clinical test facilities in Arizona and Nebraska as well as in Belfast, Ireland, and Zurich, Switzerland. Celerion has been involved in clinical testing for over 40 years and has a total of 750 clinical beds available. People who do the Phase 1 trials and take drugs to prove they are safe or are subjected to other medical tests are compensated nicely for their time. Misiak says they are usually paid about $250 per day, but some trials may pay more, depending on the risks to the participants.

Read Full Article: Phase 1 Clinical Trials Are Key Step in Drug-approval Process

Read Full Article: Phase 1 Clinical Trials Are Key Step in Drug-approval Process

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