Questions to ask before starting a clinical trial...?

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zephyr
Posts: 369
Joined: Thu Aug 18, 2016 7:31 am

Questions to ask before starting a clinical trial...?

Postby zephyr » Tue Dec 19, 2017 6:11 pm

Forgive me if this question has been asked and answered elsewhere. I did a search but didn't find anything specifically on point. That said, the search turned up LOTS of results and I may have just missed the one I needed.

When going into a Phase I clinical trial, there are obvious questions - dosage, timing, short- and long-term side effects, risks, etc. - but what are the less obvious questions a patient should ask? For those of you who have been in trials, are there any questions you wished you had known to ask at the beginning?

Thanks in advance for any assistance.
Nov-2009 Early stage CRC, routine colonoscopy
2010-2014 F/U colonoscopies, all clear
Jun-2016 CRC during F/U colonoscopy, surgery, Stage 4, KRAS, MSS
Aug-2016-May-2018 Folfox, 5FU, Folfiri & Avastin
Aug/Sep-2018 YAG laser surgeries (Germany), 11 nodules removed
Nov-2018 clean CT scan
Mar-2019 New lung nodules
Apr-2019 Dec-2020 Xeloda/Avastin, SBRT, cont. Xeloda/Avastin
Mar-2021 Forfiri/Avastin
Mar-2022 Ablation & Thoracotomy
Feb-2023 Folfiri & Avastin
Nov-2023 Xeloda & Avastin

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O Stoma Mia
Posts: 1709
Joined: Sat Jun 22, 2013 6:29 am
Location: On vacation. Off-line for now.

Re: Questions to ask before starting a clinical trial...?

Postby O Stoma Mia » Thu Dec 21, 2017 1:19 am

zephyr wrote:... When going into a Phase I clinical trial, there are obvious questions - dosage, timing, short- and long-term side effects, risks, etc. - but what are the less obvious questions a patient should ask? For those of you who have been in trials, are there any questions you wished you had known to ask at the beginning?

If you are considering a Phase 1 clinical trial, be sure that you understand the objectives of the trial. If you are considering a specific Phase 1 trial, then you can look up the study design in the clinical trial database. If you need help in interpreting what will be done in that particular trial, then you could post the clinical trial identifier for that trial and someone here might be able to give an interpretation of the study design.

In general, Phase 1 clinical trials are concerned with mapping out the side-effects profile for the new drug. A common objective for Phase 1 clinical trials is to determine the Maximum Tolerated Dose (MTD), which means that the patient will be put through a dose-escalation protocol, with ever-increasing doses, until the patient can no longer tolerate the drug. This may not be what you want, since in Phase 1 trials, they are not primarily concerned with the effectiveness of the drug or whether the drug can or cannot shrink tumors. The testing of effectiveness of the drug normally comes later, in Phase 2 trials.

Here is a brief overview of Phase 1 trials.

https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_I
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Last edited by O Stoma Mia on Thu Dec 21, 2017 12:34 pm, edited 1 time in total.

zephyr
Posts: 369
Joined: Thu Aug 18, 2016 7:31 am

Re: Questions to ask before starting a clinical trial...?

Postby zephyr » Thu Dec 21, 2017 7:31 am

O Stoma Mia wrote:In general, Phase 1 clinical trials are concerned with mapping out the side-effects profile for the new drug. A common objective for Phase 1 clinical trials is to determine the Maximum Tolerated Dose (MTD), which means that the patient will be put through a dose-escalation protocol, with ever-increasing doses, until the patient can no longer tolerate the drug. This may not be what you want, since in Phase 1 trials, they are not primarily concerned with the effectiveness of the drug or whether the drug can or cannot shrink tumors. The testing of effectiveness of the drug normally comes later, in Phase 2 trials.


Thank you so much for redirecting my focus. I was so caught up in some of the details that I missed the big picture.
Nov-2009 Early stage CRC, routine colonoscopy
2010-2014 F/U colonoscopies, all clear
Jun-2016 CRC during F/U colonoscopy, surgery, Stage 4, KRAS, MSS
Aug-2016-May-2018 Folfox, 5FU, Folfiri & Avastin
Aug/Sep-2018 YAG laser surgeries (Germany), 11 nodules removed
Nov-2018 clean CT scan
Mar-2019 New lung nodules
Apr-2019 Dec-2020 Xeloda/Avastin, SBRT, cont. Xeloda/Avastin
Mar-2021 Forfiri/Avastin
Mar-2022 Ablation & Thoracotomy
Feb-2023 Folfiri & Avastin
Nov-2023 Xeloda & Avastin


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