For those that aren't aware (possibly that's everybody except my colleagues) - I work in clinical trials. I work for a pharmaceutical company, and I build the forms which the doctor accesses online to fill in the data we need, I program checks that look for odd/inconsistent data, and I get the data out in to datasets in the right format for the statisticians to do their magic with. I'm very familiar with clinical trials from the sponsor's point of view (sponsor = company/institution/etc running the study).
At my planning visit I was invited to join an observational study. Observational, in this context, means there is no intervention - no medicine or procedure or something else being tested. This is great because it means there will be no difference to my treatment whether I participate or not. Though to be fair, it's not like they would be allowed to do a trial that gave, say, placebo radiotherapy!
Each day of my radiotherapy, I'm having a CT done first. This records my exact position, so the radiotherapy machine knows where is tumour and where is not, and delivers the radiation appropriately. Because the CT scanner is built in to the radiotherapy machine, and the treatment is being image guided and intensity modulated, this all adds up to the fact that they will know not only exactly how much radiation various bits of my tumour got, but also exactly how that relates to the other structures in my head (i.e. the healthy tissue, how much radiation it was expected to get, and how much radiation it actually did get).
If I didn't join the study, here's what would have happeend: couple of tubes of blood drawn pre-radiotherapy, and then annually after radiotherapy, to monitor pituitary function.
Of course, I did join the study, so this is what will happens: before radiotherapy, have a hungry day: Fast from midnight, get to hospital and have blood drawn. Be given some glucagon, have successive blood draws to monitor growth hormone response. Be given some thyrotropin-releasing hormone, have successive blood draws to monitor thyroid stimulating hormone response. Be given some synacthen, have successive blood draws to monitor adrenocorticotrophic hormone. All in all, about five hours of giving me things that should make my pituitary do stuff, and then watching what it does. After all of which, I will be given something to eat and drink, hurrah!! To be repeated at 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after radiotherapy. In the middle of the one-year gaps between testing, have the standard test I would have had annually done by the GP.
So I get monitored twice as often as I would have,
which is obviously good for spotting sooner if something goes amiss.
Yes, I have to be hungry, but that's not the end of the world, really,
it isn't (although it may not seem like it,
when I'm hungry I can be a little bit grumpy...) And it's only seven
times in five years. And, of course, for Science
The magic will happen when all radiotherapy machine data (to determine how much radiation went where) and the blood test results (to monitor pituitary toxicity) get tied together across 2,000 patients. The hope is that it will become clearer that if we treat at point X with Y Gy of radiation, side effect Z is more likely/less likely/guaranteed/etc. Treatment is already precise, but it could become even more precise - in future it might be possible to still treat your tumour but reduce the radiation exposure to certain areas of healthy tissue (e.g. beam the radiation in from a different direction) to reduce certain side effects, if it turns out that particular areas are extra-sensitive.
Because I'm unavailable next week, and radiotherapy starts on the 27th, I'm actually doing my first visit in two parts. Part one - non-fasting, one hour - is happening tomorrow afternoon. Part two - fasting, five+ hours - will be done in the morning before my first radiotherapy on Monday 27th. As seems to be the case with so much of this process now, curiously excited by it allFor my colleagues, I will be taking notes and no doubt letting you all know what it's like to see a trial from the other side!
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That's fascinating.
You have done a good job of turning what seemed like a frightening experience into worthwhile and interesting participation in a trial that makes things better, whilst explaining how it works in plain English.
I don't know how many times I've read Dr Ben Goldacre saying "Always volunteer to participate in trials" and you've given a good account of the potential benefits of doing so.