Let’s Talk About Clinical Trial Washouts

A friend of mine — a fellow EGFR lung cancer survivor — passed away this week. Unfortunately, this is not an uncommon occurrence in the lung cancer community, but there is one heartbreaking similarity between my friend’s recent death and the death of another lung cancer friend a couple of months ago.

Going off of medication

Both women were in a “washout” period, waiting for a clinical trial to begin that had already accepted them as patients. What is a washout period? A washout period is as a period of time during a clinical study when a participant is taken off a study drug or other medication to eliminate the effects of the treatment.¹ So basically, it means a time when a lung cancer patient is not being actively treated for his or her cancer while waiting for a new treatment to begin.

Many lung cancer clinical trials require washout periods prior to starting the investigational medication. Don’t get me wrong, I understand why these washout periods are included — investigators want to know the impact of their new treatments independent of other influences that might affect the results. However, a balance is desperately needed to protect patients better. Depending on the trial and the type of medication that a patient is stopping, these washout periods can sometimes be weeks long. That’s a long time for someone with advanced lung cancer to be off medication!

Are long washout periods necessary?

It’s kind of a paradox — in order to qualify for a clinical trial, lung cancer patients need to be relatively healthy and able to withstand an experimental treatment. There are tons of inclusionary and exclusionary criteria that often weed out the sicker patients who have been on multiple lines of treatment or who have serious progression. However, once a patient qualifies for a trial, the washout period begins; this period without treatment prior to the trial start can lead to increased progression, sicker patients and even death.

What is the answer? Well, I think clinical trial designers need to take a closer look at the necessity for lengthy washout periods when writing clinical trials. I was discussing this topic with a fellow advocate friend of mine and I thought he had a really good point — washout periods would never happen in real life outside a trial!

Starting new medications

Once drugs are FDA-approved, patients start new medications directly following previous treatments. They usually don’t wait weeks post-progression to change treatments after a new plan has been identified! For example, when I progressed in November 2016, I stopped taking Gilotrif one day and started taking Tagrisso the next day. This was possible since both drugs were already FDA-approved, but would likely not have been possible if Tagrisso was still in clinical trials.

I hear lots of discussion from medical professionals about the urgent need for increasing patient participation in lung cancer trials. I believe the necessity for lengthy washout periods should be carefully considered. Being part of a trial that requires a long washout period can be as much of a deterrent to patients as other barriers to clinical trial participation, such as time, travel, and financial requirements.