Anyone participated in a clinical trial?

[thestrangebrew1]

I had laser procedure Friday on my right eye for diabetic retinopathy and my specialist said I was a candidate for a clinical trial to help prevent my eyesight from getting worse and could try the treatment for my left eye. Just got off the phone with one of the coordinators for the trial and I guess it's on phase 3 now, and she's going to send me the consent information. Normally, I'd be all for doing something like this, but it's for my eyes so I'm not too sure. But since it's in phase 3, that's a good thing from what I understand?

 

[Brainonska511]

Some background before I jump into a spiel: I work in medical communications and have helped to create a lot of material for many clinical trials over the years (and communicate data and other useful info about investigational products before and after approval).

For the most part, but especially in a phase 3, you're always going to receive at least the standard of care. And though there are no guarantees, companies and investigators are generally confident that something could work if they're going to be running a phase 3 trial that would lead to an FDA submission (if positive results). Phase 3 trials are where efficacy and safety are tested against some standard of care (like a placebo or another, standard drug, depending on the condition).

The informed consent form will likely be a little lengthy, but it should contain a lot of information to address questions you may have and any time commitments required for participation; and of course, always feel free to reach out to your doctor or the coordinator to get clarification.

On a side note, participating in earlier trials can also be beneficial, even if the evidence supporting a trial is not as robust as what would exist at the start of a Phase 3. Phase 1 is safety testing in healthy humans or safety/preliminary efficacy in patients who may not have any further treatment options. Phase 2 is usually a bit larger and they try to do a bit more efficacy testing, but mainly also safety in a larger group.

 

[thestrangebrew1]

Awesome info, thanks. I just received the consent docs so I'll review them and then go to the initial consult to get any questions answered and to determine for sure if I'm a candidate. After that, I'll make a decision. We'll see!

 

[Brainonska511]

Awesome info, thanks. I just received the consent docs so I'll review them and then go to the initial consult to get any questions answered and to determine for sure if I'm a candidate. After that, I'll make a decision. We'll see!

Great to hear. Definitely nothing wrong with a clinical trial, especially when sponsored by a pharmaceutical company in the United States in partnership with a legitimate clinical trial site. And there are definitely a lot of big upsides, such as early access to a revolutionary treatment and additional clinical monitoring. Many phase 3 trials may also have "crossover" - after some defined time, those trials let patients who received placebo (or the standard of care non-investigational agent) to receive the investigational product.

The only time I'd ever be wary of a trial is one of those BS stem cell clinics that try to use loop holes to use stem cells in unapproved ways by claiming they are doing "n=1 trials" (and often result in patient harm), and from what you describe, it doesn't sound like this is the case at all.

 

[DylanCooper]

Great to hear. Definitely nothing wrong with a clinical trial, especially when sponsored by a pharmaceutical company in the United States in partnership with a legitimate clinical trial site. And there are definitely a lot of big upsides, such as early access to a revolutionary treatment and additional clinical monitoring. Many phase 3 trials may also have "crossover" - after some defined time, those trials let patients who received placebo (or the standard of care non-investigational agent) to receive the investigational product.

The only time I'd ever be wary of a trial is one of those BS stem cell clinics that try to use loop holes to use stem cells in unapproved ways by claiming they are doing "n=1 trials" (and often result in patient harm), and from what you describe, it doesn't sound like this is the case at all.

Thank you so much for explaining in detail.

 

[BoomerD]

For some things, I think I'd be willing to be a guinea pig...but for my eyes? 😱

I had a hard enough time agreeing to have cataract surgery in 2023...and that's a well-established procedure.

I hope it works for you...and the side-effects, if any, are minimal at the worst.

 

[Brainonska511]

For some things, I think I'd be willing to be a guinea pig...but for my eyes? 😱

I wouldn't do it if I had perfectly healthy eyes, or an eye condition that was well managed and controlled with currently available treatments. But if I had a degenerative eye condition where the current medications weren't very effective, sure, why not?

 

[thestrangebrew1]

For anyone who is even remotely interested in the trial, it's called GLOW2, and the drug is Tarcocimab by Kodiak Sciences. A new type of drug in phase 3 that lessens the amount of injections you'd have to take for diabetic retinopathy, with the potential for preventing retinopathy from getting worse. My concern is this particular study only has a limit of 250 patients. Seems limiting just from a numbers perspective. IDK. I'm still on the fence with it.