Clinical trials - are doctors allowed to talk?
 

I've been wondering why it's been so hard to find out ANY information on the effects and success rate of the trial Kiri is joining for ARRY-380, and it occurred to me that maybe because the drug IS still in the trial stage, the docs aren't allowed to reveal ongoing results?

Any thoughts?

Re: Clinical trials - are doctors allowed to talk?
 

I'm not sure, but I believe that doctors also only get the results once the trial is wrapped up, all numbers have been crunched and all data processed. So they may have anecdotal information based on what they see / hear, but might not want to share it, because it is anecdotal and could be misleading? My onco seems to be hesitant to share info on trials, too, but I figured it might be because I'm still in first line, so she feels there's no need... Also not sure how up to date each doc is on what's going on - there's lots of activity and they might have a hard time to stay abreast of everything.

I could be wrong, though...

Re: Clinical trials - are doctors allowed to talk?
 

I suspect that it is too early in the clinical trial to have established effects and success rates. This is a Phase Ib trial. The doctors simply don't have the data to share with you, yet.

Here's is an explanation from NCI on the purpose of the different phases of clinical trials:

Phases of Clinical Trials

Clinical trials to test new cancer treatments involve a series of steps, called phases. If a new treatment is successful in one phase, it will proceed to further testing in the next phase. During the early phases (phases 1 and 2), researchers figure out whether a new treatment is safe, what its side effects are, and the best dose of the new treatment. They also make sure that the treatment has some benefit, such as slowing tumor growth. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid.
There are also very early (phase 0) and later (phase 4) phase clinical trials. These trials are less common. Phase 0 trials are very small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness. They take place after a new treatment has been approved and is on the market.
The following shows the number of patients that take part and the purpose of the most common phases. Although the trial phases are explained in the context of drug treatment trials, the same concepts apply to most types of clinical trials.
Phase 1

Purpose:

• To find a safe dose
• To decide how the new treatment should be given (by mouth, in a vein, etc.)
• To see how the new treatment affects the human body

Number of people taking part: 15–30
Phase 2

Purpose:

• To determine if the new treatment has an effect on a certain cancer
• To see how the new treatment affects the body

Number of people taking part: Less than 100
Phase 3

Purpose:

• To compare the new treatment (or new use of a treatment) with the current standard treatment

Number of people taking part: From 100 to several thousand
Some researchers design trials that combine two phases (phase 1/2 or phase 2/3 trials) in a single protocol. In this combined design, there is a seamless transition between trial phases, which may allow research questions to be answered more quickly or with fewer patients.

Re: Clinical trials - are doctors allowed to talk?
 

I have been on a few trials and have found that doctors actually like sharing data, when they have it. This one just may be too early, as 'lizbeth pointed out.

Best of luck in all you and your family decide,
Karen

Re: Clinical trials - are doctors allowed to talk?
 

Hi Kirismum,

I work in research (though not clinical trials), and as the ladies have said, it sounds very much like it's too early to have results. Until they have a decent number of people having had the treatment for long enough, the researchers can't crunch the numbers. So the doctors probably don't have figures to work off. Mum's Onc is involved in clinical trials and happily shares results once they're out, but that's from trials that started quite awhile back.

Research is often quite slow moving because it takes quite a lot of information (lots of people & long enough follow-up) to be confident the results are meaningful and not just a fluke - and they are so important to get right. Not sure if it's the same in clinical trials, but in social research we generally do all our recruitment of participants and data collection before getting out any results.

Must be hard not having the info though. Best wishes to you and your daughter,
Miriam

Re: Clinical trials - are doctors allowed to talk?
 

My doctor is aware of most clinic trial that pertain to breast cancer. He attends monthly meetings locally and nationally at various hospitals, he's also attended ASCO symposiums, and other organizations. He's talked to me about the most recent clinical trials. He advised me against one that its at the moment on Phase 2, - I don't want to mention the name (s) as some of you have been on it- - He did not like the side effects, so it was a no. It's important to establish a relationship from the get go, ask questions, and be open to everything your doctor has to say. You might not like what you hear sometimes, but I think most of the time they want the best for you.

Re: Clinical trials - are doctors allowed to talk?
 

Ah . . . that is the purpose of Phase II- to see how it affects the body.

Thankfully we might have the 15 to 30 brave souls who enrolled in the trial to determine this, some on this very board.


We need to take an active part in participating in clinical trials or new medications will never become FDA approved. While I value the input of medical professionals, I become concerned when a doctor would influence a clinical trial.

A patient is not obligated to finish a trial and may drop out for any reason.

I encourage all of you to consider a clinical trial, to pay it forward in the same way as the women who joined and brought us Herceptin, Tykerb, Perjeta and Kadcyla.