Has anyone got any thoughts and views about, or even experience with clinical trials?
We are hoping that my GF is enrolled on a clinical trial for immunotherapy involving checkpoint inhibitors, which are antibodies that can apparently kill cancer cells.
We are told that clinical trials are randomised and that they are blinded given that participants, researchers and staff don’t know what treatment is actually being given. this, as we have been told, is to eliminate any bias.
Now, I can understand the need for blinded and randomised trials for certain things, but I am struggling to get my head around this for secondary breast cancer, where metastatsis spreads to other parts of the body.
I’m almost two years in to a endocrine trial (oral/hormone chemo) after my primary tumour, diagnosed in 2013 mutated.
Funnily enough, I was chatting to my key nurse about blind trials and placebos at my last clinic (there are a lot of tests and ECGs to get through so we have plenty of time to chat).
The trial that I’m on doesn’t have a placebo element as it happens, but most of the trials she’s involved with do. I asked her about the fairness and the poor souls who get the short straw but it’s not as straightforward as we lay people might think.
If I understood her correctly, they have to have a basis of comparison so they choose patients who are very unlikely to respond to the new drug so it makes little difference whether they take it or not but there may be a psychological element in quality of response so that’s why they don’t tell people.
it may help you to know that the trial I signed up for was testing a three-drug regime. Six months in, I developed pneumonitis which they suspected was caused by one of the drugs. They took me off that one but asked me to stay on the study so they can compare me to others having been on two regimes - three drugs compared to two.
Hi, I’ve also been on a drug trial for 2.5 years, it also isn’t a blinded trial as I joined at phase1 which is a dose escalation one. Patients join on a pre determined dose which increases. They are looking for effectiveness vs side effects at each dose.
You are correct in saying the reasons for blinded trials, yes there is a risk that you are on the placebo but you should be very carefully monitored so that as soon as you have any progression you will be off the trial. That is the case whatever the type of trial, I was monitored weekly and with CT scans every 2 months initially.
Personally, I don’t think, as Anders said, they choose patients that are unlikely to respond to a new drug. Trials are funded by drugs companies anxious to have success so it doesn’t make sense to me. My drugs have been successful partly because I have a specific genetic mutation that is targeted.
My advice is to gain as much knowledge as possible before you sign up, specifically on the monitoring aspect. Wishing you and your GF all the best.
Unfortunately my GF couldn’t get onto the trial because she didn’t meet one of the conditions in that she didn’t have taxol last September when she was on Chemo.
The hospital started her with EC to be followed by accelerated Taxol, but since the tumour wasn’t shrinking they stopped chemo and proceeded with a mastectomy plus lymph node removal. It was only about 2 months or so after radiotherapy that the cancer came back.
On Friday she started chemo with taxol. I can only hope that it will help.
I had a very interesting (and frank) discussion yesterday with a clinical nurse on the Macmillan phone helpline, which answered a lot of questions i had about clinical trials. He really simplified the aims, and implications for me, and also emailed me a list of the trials available from different companies.