RE: Unoffical Positive News8 Dec 2022 16:28
Berm is correct with respect to the checkpoint inhibitor vs moditope. The two arms of that trial would be CPI alone (standard of care) vs CPI + Modi-1 (investigational drug combination).
When it comes to other arms, things get a bit more complicated. When a new drug such as moditope is tested in patients who have exhausted all safe, effective treatments, comparing a moditope with a placebo may be appropriate and would allow researchers to determine the good (and bad) effects of modi-1. However, ethically there are concerns about a trial of this design.
We would consider a placebo controlled trial to be ethical only when 1) it is absolutely scientifically necessary, 2) appropriate ethically to run a trial in this manner and 3) when patients are clearly informed that they will receive placebo drug AND whether they will receive the active drug at some point during the trial.
In this situation, a placebo may be ethically justified if diseases have high placebo response rate (i.e. the disease can go have spontaneous response rates), in conditions where they become alternately worse or better (fluctuating disease or fluctuating signs and symptoms of the disease but maybe not the actual disease itself or where the disease has an unpredictable course. Furthermore it might be appropriate when existing therapies are minimally effective or have serious side effects, or in the absence of any effective therapy.
It is also important to consider that patients randomly assigned must not be substantially more likely to suffer harm - this includes death, sever discomfort, irreversible illness, disability or other substantial harms, even if these are reversible.
Placebo controlled trials are never appropriate when a highly effective or potentially curative treatment is available. The exception being in situations where the trial allows the patient to receive the new treatment/placebo in addition to the potentially curative treatment (think a new pain relief therapy for cancer patients, doesn't prevent them still having the standard of care chemotherapy).
Placebo-controlled trials should also ensure that patients receive good supportive care during their participation in the clinical study. Trial designs can be used to minimise the chances that a patient receives a placebo only. For example, for many clinical trials, participants may be permitted to crossover to the active arm of the trial at a specific point - be that after x weeks on treatment/placebo or say at the time of disease progression. In such clinical trials, all patients have the opportunity to receive the new treatment, although some receive it sooner than others do. These cross-over trials can be incredibly useful.
The correct design of a cancer trial is important, both ethically and to get the most amount of scientific data about the new therapy as possible. Hence lots of work goes into correct trial design.
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