Some thoughts...
1.How long do you expect treatment to last?
- Until first Grade 3 (serious) or Grade 4 (life threatening) adverse event?
- Until there is evidence of progression while on treatment?
- Until the standard dose can no longer be tolerated?
- Until the end of the study (2025)?
2. Are chemo breaks / pauses in treatment allowed?
3. If the drug works well for you, will you be able to continue with it after the end of the trial?(probably not, see red-font notice in trial protocol)
4. Who will be in charge for the duration of the trial?
-What role does the trial coordinator have?
-What specialty / expertise does the trial coordinator have? What kind of doctor is he?
- What role does your local oncologist have for the duration of the trial?
- What role does your multidisciplinary team have for the duration of the trial?
-Will your team have much power to make decisions when the trial is ongoing, or is everything going to be dictated by the trial protocol?
5. Who will you be meeting with on a regular basis during the trial -- your local oncologist, or the trial coordinator?
6. Are you allowed to take supplements or alternative treatments during the trial?
7. Where are the clinical trial test results kept?
- Are they going to be accessible by the patient in the patient's portal?
- Are the results made available to the whole team?
-Will the clinical trial team have access to all previous tests / scans, or only the results appearing after the trial's baseline.
8. Efficacy - how often are scans done?
- Are scans done on a fixed, inflexible shedule .. every 6 months or so?
-Can your local oncologist order scans or tests that are not listed in the trial's protocol?
- Can a patient request a different kind of scan (PET/ CT or MRI)?
- Can a patient request a second opinion on scans done during the trial?
-What if there are differences of opinion about scan interpretation?
9. Clarification? "
tumor tissue sampling to determine my eligibility" ... Tissue from which tumor? By which method -- by needle biopsy??? . Or is it a sample from the original primary tumor still in long-term storage?
10. Also, what kinds of panels will be included in the blood tests? How comprehensive, how extensive? how many cancer biomarkers assessed, etc.? Will they be testing CA 19.9? Will the be doing any ctDNA tests for circulating tumor DNA, for example. Will there be any panels to assess general level of systemic inflammation, etc.? Are these tests only for establishing eligibility? If so, then when will they be doing comprehensive testing to establish a good study baseline, and what tests will be included in that baseline?
11. Timeline? How long will it take them to determine your eligibility? If you are deemed eligible, then how long will it be before you can start treatment?
12. Informed consent in Australia.
https://www.bmj.com/content/324/7328/39
Summary points
In the past decade both English and Australian courts have adopted a more patient centred standard in deciding what risks doctors must disclose to patients
Professional bodies have issued guidelines to help doctors inform their patients
Yet in Australia many doctors still do not understand their legal duties and many are being held liable for their failure to inform