Clinical Trials

Most of us, I’d wager, know someone who’s been in a clinical trial, or wanted to be. Clinical trials are what you do when your disease, often cancer, breaks through the accepted treatment protocols and resumes destroying your body. Maybe a drug under development, not yet approved for general use, will work.

I know two people currently who are using drugs in clinical trials. One is the 40-something son of a dear friend, a young man who has lung cancer. Right now, the clinical trial drug seems to be having positive effect; his cancer looks to be in remission. Another is a friend here in Seattle who’s had a recurrence of what started as bile duct cancer. He’s on the last option the medical community has to offer, and it’s not yet clear if the drug provided through a clinical trial will have enough positive effect to give him more months of life.

Getting into a clinical trial is often hard; you have to fit the protocol. Part of that is the drug company wanting to control the variables, so they know that whatever changes occur in your health status is in fact due to their drug, not something else. Part is the drug company wanting to have healthy enough patients to withstand the rigors of treatment. “We think the drug worked but unfortunately the patient died” is not a successful marketing slogan.

Should drug companies be forced to relax their stringent protocols, to give more desperate patients a chance? Or, does the science require a process pretty much like the one we have now?

I imagine your answer has a whole lot to do with whether you or a loved one is desperate to get into a trial.

2 thoughts on “Clinical Trials

  1. Access to the latest treatments are life saving to people with serious illnesses. Clinical trials give us evidence to know if a treatment works and if there are side effects. Sometimes, particularly with life threatening diseases, even if a clinical research trial has potential serious side effects, a particular individual may accept the risk because the benefits outweigh the risks.

    Research clinical trials in the USA require approval from a research board. The researchers go through a very rigorous process to get approval to do the study. In cases where the treatment includes a medication, the drug must be approved by the FDA. It is hard to get a drug approved in the USA. Sometimes the FDA wants years of research data from other studies done out of the USA. That’s why some people may go out of the USA looking for these treatments. The downside of going outside the country is that the protocol may have untoward effects not yet identified.

    In other cases, clinical trials may propose using a medication used for a particular disease on something else. This is “off label”. For example, a family member with an unusual blood illness was no longer responding to traditional medicine. An off label drug had been found to be useful in European studies. The person couldn’t get access to the Med in her community. She had to go out of state to an academic teaching hospital that had a clinical trial. The patient met with criteria for the study and the doctor prescribed the medicine. The insurance company refused to pay because the medicine was “off label”. The patient asked me to write an appeal. I did, including providing research evidence, but the insurance still refused to pay. In fact, insurers refuse to pay for financial reasons. In this case, the drug cost $4000 per dose, which was weekly. Most pharmaceutical companies have a foundation for people that can’t afford the medicine. Ultimately, this person was able to get the medicine free from such a Foundation.

    Some of the new cancer treatments are “biologics” that specifically target the genetics of a tumor. These have extended the life of people with some cancers. In some cases , many of the tumor cells mutate and the disease returns but that could be in years.

    Clinical trials offe hope to thousands of people. Often, the patient and their family/close friends do the research to find out about these trials.

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