Yes Clinical Trials Are Trials

Yesterday I read this article on a clinical trial in France where one patient is brain dead and five others are hospitalized. I was very shocked by this. It was run in full compliance with local regulations, under medical supervision, and it was immediately stopped.

We need to remind ourselves on a few things about clinical trials. First of all clinical trials great. They serve a wonderful purpose in the development of new drugs. It is crucial that they continue. All cancer people hear about clinical trials and whether they are eligible and if they could help them or allow them to help future patients. They often often are a last ditch life saving attempt by patients.

Second of all, if you are selected for a clinical trial you do not know if you will even receive the medication being tested or a placebo or a previously approved medication. This is what leads some patients to travel overseas for treatment where they can get the new medication that is not yet approved at home.

Third of all a clinical trial does different things at each level of the trial from the US National Library of Medicine:

"Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

• Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
• Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use."

You will note the first three phases cover the drug's safety. And Phase IV is why more research is always needed.

But back to France. That clinical trial that proved fatal was a Phase I trial where they were testing different dosages. Obviously they had the wrong range in mind or something else when they started. It is a very rare occurrence that deaths occur in clinical trials but not unheard of. I think that I have heard of other complications from clinical trials but I do not have any data to back this up.

So I think this death and other medical issues relating to the clinical trial raise the issue of clinical trial safety - something I think that we often overlook as patients. I know as a patient I think of clinical trials as wonderful things and help ourselves and future patients. But I never sit and wonder if I could be hurt by participating in one. Now I think I will consider it.