1 year since RALP & Clinical Trial

I joined a clinical trial for my RALP surgery a year ago. As of today, I'm no longer required to submit my weekly questionnaire results, as my one year participation is completed. It was supposed to be a blind experiment, but I was billed early in the program for what insurance doesn't cover, so I already knew I was in the group who received the amniotic tissue implants.
Clinical trials are lucrative for the sponsor, who wants approval for their product (CLARIX ® Surgical Allograft). They're lucrative for the participating hospital and doctors. They're hope for the selected half of the patients who receive the treatment, but they can be expensive for the patients too. I'm considered a success with regards to the clinical trial, as it's intended purpose was to repair any potential damage caused by the surgery. I have absolutely no incontinence. I have the same erectile function as before the surgery, without any drug. My PSA also remains undetectable.

Post Edited (Your Friend) : 1/23/2023 1:35:36 PM (GMT-8)

I once had a colleague who went by Randolf Walton III. For a chuckle, I'd say Randy, do you have the time? Without fail, he'd politely correct me on his name, then give me the time in hours, minutes and seconds, as if his Casio was an atomic clock.

Federal law requires most health insurance plans to cover routine patient care costs in clinical trials under certain conditions. Such conditions include:

You must be eligible for the trial.
The trial must be an approved clinical trial.
The trial does not involve out-of-network doctors or hospitals if out-of-network care is not part of your plan.
Also, if you do join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits.

Health plans are not required to cover the research costs of a clinical trial. Examples of these costs include extra blood tests or scans that are done purely for research purposes. Often, the trial sponsor will cover such costs.

Plans are also not required to cover the costs of out-of-network doctors or hospitals if the plan does not usually do so. But if your plan does cover out-of-network doctors or hospitals, they are required to cover these costs if you take part in a clinical trial.

mattam said...
I seem to recall that we have a member whose husband was in a several year's long trial for Xtandi. When the trial ended the drug company no longer provided Xtandi to the participants.

So, they were saying thanks for the data you provided to prove the efficacy of our billion dollar drug. If you want to continue with it, you'll have to figure out a way to pay for it.

That stance may be legal, but it seems unethical to me.

Before entering any clinical trial, you'll be asked to read and sign the Informed Consent Form(s). Unfortunately, these can easily run to 30 pages and up, depending on the trial. Take it home and go through it carefully before signing. Write down questions to ask. Your research nurse may not have, and the sponsor may not give, answers to some questions, like getting the study medication fee after the trial is over, if that info is not in the Informed Consent. IMO sponsor will more often than not do so if, when you leave the study, the medication is still experimental and not otherwise available and you were still getting benefit.

If you will be randomized and blinded as to getting the drug or the control (which may or may not be a placebo), you can ask about the possibility of crossover. Let's say you get bumped from the study (e.g., because your mets have grown in size) and you were not in the study-drug arm. Some studies let you then "cross over" to the other study arm and start getting the study drug (you are, of course, off the main study, but the data can still be very useful to the sponsor and you get a chance to try the new medication).

You can leave any study, at any time, for any reason (nor are you compelled to give the reason). That includes at the very start of unblinded studies that have different treatment arms, if you decide you really don't want the regime you are randomized to.

Djin

Post Edited (DjinTonic) : 1/24/2023 7:30:53 AM (GMT-8)