Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
Has anyone within our community had an experience in which they've had to exit a trial before it's completion?
You don't have to give a reason for leaving a trial, but obviously, it would be good manners and helpful to the researchers if you do so. I've participated in many clinical research studies and two clinical trials and the participant notes always say that one can leave at any time and that you do not have to give a reason. You should always cancel appointments though, if you are unable to attend - the trial is funding every minute of doctor's time, which will be wasted if you're not there.
Yes, I have had to leave a clinical trial. Although, it is a moot point whether I left or they told me to leave! During the Lasmiditan trial (for migraine) I had a very bad reaction to the drug when taken at home and landed up in hospital. For my own safety I had to leave, but you could not persuade me to take the drug again, the effects were so severe.
Having left, I now find myself in a bit of a grey area. My local doctor doesn't know anything about the drug I took and I am no longer under the care of the trial. I still suffer from the effects of the trial, the doctors consider them psychological in origin, I suspect a seratonin inbalance in my brain may contribute, but how can we know? It's a new drug. Regardless, I am left wondering what care should be provided for me and by who?
The decision to stop participation in a clinical trial should be made only after much thought and consideration. The patient's safety is of the utmost priority and the researchers certainly understand if you feel you cannot participate anymore. However, leaving a study increases the likelihood that a study will not meet its endpoints and therefore not be approved by the FDA. Many studies would prefer for you to stay in the study by only completing follow up calls if possible, and if not at least come in to complete the "End of Study" visit early. Lastly, if you do stop a trial early you need to bring the study medication back to the site. Research sites are seen very negatively by Sponsors when it is recorded that subjects dropped out of the study without explanation. In conclusion dropping out of a study can have severe effects on both the study medication and the research site. The patient should carefully consider remaining in the study and if they cannot then they need to do the responsible thing and tell the Study Coordinator why and complete a final visit.
Indeed. Speaking personally, I was very keen to return for the end of study check, to return the medication and have a medical. Which reasured me that I was (reasonably) ok. Before enrolling with a study I would encourage everyone to read up on it and be sure they can commit to it. I regard a study as at least as important as work, no matter whether I'm being paid or not.
In 2012 I joined a Phase 3 study for one of two new NON-chemo pills for treating a blood cancer ( CLL -Idelalisib/Zydelig). After 30 months, in 2015, I became refractory to the drug and worked with the clinical trial team to wind down my treatment.
I continue to use the lead doctor and his team as my primary medical resource, my cancer has progressed 2 more times, and each time I was given the option to enter current trials for recently approved NON-chemo drugs or have them prescribed "off-label".
Due to the high frequency of full body CT scans (4-6 per year) and high frequency of clinic visits under the trial protocols, I opted for the "off-label" approach to minimize my radiation exposure/risk of secondary cancers, and reduce my exposure to hospital borne pathogens that can evade my compromised immune system.
I became intolerant (side effects) of the 2nd drug in 6 months, but drug #3 has given fantastic results with no side effects. I am now cancer free (Minimal Residual Disease negative), and will discontinue treatment at the end of this year. We hope for a multi year remission, but when the cancer returns, I will restart drug #3 (Venetoclax).
Best of all, as a result of the clinical trial, I now have a world class expert team guiding me, and whatever secondary infections & side effects I get are treated by equally outstanding experts at the same hospital.
Len
