Phase 1 Clinical Trials – An Early, But Key Step, in Drug-approval Process
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.
He said there is a network of people who do Phase 1 testing as a full-time job, earning somewhere between $40,000-$60,000 per year by participating as human test subjects in assorted Phase I trials. An online community for these people exists, he added, a place where they share test opportunities and discuss the pros and cons of how they are treated at particular test sites.
I went looking online for some of these communities, and found several commercial sites recruiting Phase 1 participants. Study Scavenger is one such enterprise, and its site has extensive listings for many different companies looking for subjects. It offer an app that allows people to put in their testing preferences and geographical information, and will connect them to the study leader if they have questions. Study Scavenger even offers to send email updates when new recruiting notices for trials that meet a person’s profile are listed. I also found patient-run sites, such as Guinea Pig Zero, that offers insights on being a Phase 1 trial participant. Finding subjects for, and participating, in Phase 1 clinical trials are big business opportunities.
While the prospect of the money sounds good, I have to point out that Phase 1 trials are risky because it is the first time a particular drug has been given to a human, having only been used on laboratory animals before then. I recognize that these people are mainly doing Phase 1 tests for the money, but I still appreciate their willingness to be engaged in the research process. Whether they are medical pioneers or just finding ways to earn an income, Phase 1 participants are crucial to the research process and I am glad they are engaged in this critical first step in proving the effectiveness of new drug therapies.
Editor’s Note: The opinions expressed in this blog article are not those of Multiple Sclerosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to Multiple Sclerosis. Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.