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Does having an active workers compensation claim exclude you from participating in any clinical trials regarding your injury?

I have a workers compensation claim for an injury that unfortunately does not have a cure and there isn't really much medical treatment for. I am enrolled in a clinical trial for a treatment that may help, it's only likely to help during early onset, so there is a short window of opportunity to participate in the trial and to possibly prevent my condition from becoming chronic. I was told that being involved in workers compensation may exclude me from the trial, although it is not explicitly stated. It's just stated that active legal action involving your injury is exclusionary.

Doing some research I have noticed a number of clinical trials exclude people from participating if they are involved in a workers compensation case, what I'm wondering is if this is a FDA guideline, or if it is just a trial specific exclusionary criteria.

I would much rather participate in this trial if it has the chance of helping than be involved with worker's compensation for this case. Being that there's not much treatment, it's not considered a major disability (although it has a huge negative impact on my life) there's not much I can expect out of workers compensation anyway.
I know of no federal restriction.
I suspect each clinical trial has it's requirements and treatment regime that must be strictly adhered to.
most state's workers comp systems also have limits and procedures that govern treatment and benefit eligibility.
as long as the two don't conflict there should not be a prohibition.

as long as your comp doctor approves and the employer/carrier doesn't have to pay for it, I don't think there would be a problem.
the only barrier i could see is one of liability for any adverse side effects.

I suspect participation would be determined on a case by case basis as there is no universal rule on the matter.
Thanks.  The comp doctor is on board with the trial, I think the issue may be with the clinical trial sponsor.  The company conducting the clinical trials is in Europe but they are running trials throughout Europe and the US and other locations.   They make no mention of workers comp, but in the European documentation they state any active legal action involving your injury is exclusionary.  They may not be familiar with how workers comp works in the US.

I don't think my case would really qualify as legal action.  I know some workers compensations cases can possibly.  But in my case it would be impossible to sue anyway, there is no treatment for the condition, it would not be considered a disability, and there is no long term care goals, it's just 'learn to live with it'. 

I think the reason for the exclusionary criteria is the sponsor or anyone involved in the trial does not want to get dragged into a legal case or called upon to testify in one, but that would not be a risk here.

It just sucks that I might get kicked out because of workers comp when it's next to useless for my injury anyway.   I would gladly drop the workers comp case if it allowed me to participate, but I don't know if that's an option at this point.
(02-17-2016, 01:20 PM)Desdinova Wrote: [ -> ]Thanks.  The comp doctor is on board with the trial, I think the issue may be with the clinical trial sponsor.  The company conducting the clinical trials is in Europe but they are running trials throughout Europe and the US and other locations.   They make no mention of workers comp, but in the European documentation they state any active legal action involving your injury is exclusionary.  They may not be familiar with how workers comp works in the US.

I don't think my case would really qualify as legal action.  I know some workers compensations cases can possibly.  But in my case it would be impossible to sue anyway, there is no treatment for the condition, it would not be considered a disability, and there is no long term care goals, it's just 'learn to live with it'. 

I think the reason for the exclusionary criteria is the sponsor or anyone involved in the trial does not want to get dragged into a legal case or called upon to testify in one, but that would not be a risk here.

It just sucks that I might get kicked out because of workers comp when it's next to useless for my injury anyway.   I would gladly drop the workers comp case if it allowed me to participate, but I don't know if that's an option at this point.
Accepting work comp benefits is always voluntary.
What state are you in? In California new laws passed in 2013 with SB863 stating if you receive treatment outside of your work comp insurance company's MPN (medical provider network) and you have an injury resulting from the treatment, the work comp carrier is not liable for the injury. For example if you are a work comp patient in California, and have a spinal epidural that you paid cash for or used private insurance outside of the WC MPN and later found you got complications etc, your work comp carrier is not liable for any treatment or disability payments resulting from treating outside of the MPN.

I would recommend to look into this with your state and your work comp carrier. I think liability if the clinical trial goes wrong would be a good question, and would your work comp carrier provide treatment.

I would recommend to check out this clinicle trial and see if it is listed here.
https://clinicaltrials.gov/ct2/manage-recs/faq

You can do a search on the FDA website for other products from this company and see if there are adverse events. Europe has a completely different approval process than the US.

I also recommend carefully reading all forms before you sign them for this trial.
Sponsors for clinical trials do not always have insurance that covers the patient when there is an injury from the trial. Please read this article.
http://www.sheppardmullin.com/media/arti...Trials.pdf
Here is some basic info on pros and cons of clinical trials.


and how to search for clinical trials
https://clinicaltrials.gov/
(02-17-2016, 02:06 PM)California_Help Wrote: [ -> ]What state are you in? In California new laws passed in 2013 with SB863 stating if you receive treatment outside of your work comp insurance company's MPN (medical provider network) and you have an injury resulting from the treatment, the work comp carrier is not liable for the injury. For example if you are a work comp patient in California, and have a spinal epidural that you paid cash for or used private insurance outside of the WC MPN and later found you got complications etc, your work comp carrier is not liable for any treatment or disability payments resulting from treating outside of the MPN.

I would recommend to look into this with your state and your work comp carrier. I think liability if the clinical trial goes wrong would be a good question, and would your work comp carrier provide treatment.

I would recommend to check out this clinicle trial and see if it is listed here.
https://clinicaltrials.gov/ct2/manage-recs/faq

You can do a search on the FDA website for other products from this company and see if there are adverse events. Europe has a completely different approval process than the US.

I also recommend carefully reading all forms before you sign them for this trial.
Sponsors for clinical trials do not always have insurance that covers the patient when there is an injury from the trial. Please read this article.
http://www.sheppardmullin.com/media/arti...Trials.pdf
Here is some basic info on pros and cons of clinical trials.


and how to search for clinical trials
https://clinicaltrials.gov/

Great research. Good information.
(02-17-2016, 02:06 PM)California_Help Wrote: [ -> ]In California new laws passed in 2013 with SB863 stating if you receive treatment outside of your work comp insurance company's MPN (medical provider network) and you have an injury resulting from the treatment, the work comp carrier is not liable for the injury. For example if you are a work comp patient in California, and have a spinal epidural that you paid cash for or used private insurance outside of the WC MPN and later found you got complications etc, your work comp carrier is not liable for any treatment or disability payments resulting from treating outside of the MPN.

I would recommend to look into this with your state and your work comp carrier. I think liability if the clinical trial goes wrong would be a good question, and would your work comp carrier provide treatment.

I would recommend to check out this clinicle trial and see if it is listed here.
https://clinicaltrials.gov/ct2/manage-recs/faq

You can do a search on the FDA website for other products from this company and see if there are adverse events. Europe has a completely different approval process than the US.

I also recommend carefully reading all forms before you sign them for this trial.
Sponsors for clinical trials do not always have insurance that covers the patient when there is an injury from the trial. Please read this article.
http://www.sheppardmullin.com/media/arti...Trials.pdf
Here is some basic info on pros and cons of clinical trials.


and how to search for clinical trials
https://clinicaltrials.gov/

Thanks, I have researched the trial in depth and I think it's worth a shot in my case.  This is a phase III clinical trial, so safety has already been established (which occurs in phase I). Yes there is a low percentage of risks, but weighing the risks and the possible benefit and considering there is no other treatment medically available I'm committed to going through with it.  There is some coverage for inventive treatment if there are complications from the study.  Workers comp would not cover this nor would I expect them to.  The trial location has actually been very helpful with paying for travel, answering all my questions, etc.  I feel comfortable with them. 

I don't see an issue with them conflicting, but if they do I would rather drop the workers comp. 

(02-17-2016, 01:53 PM)1171 Wrote: [ -> ]Accepting work comp benefits is always voluntary.

Would not accepting it be a possibility at this point if it does become an issue?  Again, workers comp provides very little benefit for my injury and condition.
I disagree that stage I establishes a product or drug is safe. This is tested on a small group of people. After stage III the FDA will review the trial data and determine if the drug is safe and effective. Were you given the results of the last two trials including side effects?

I would not worry about your work comp claim being an issue if you are fine with possibly being responsible for any side effects. I was giving worse case scenario and have no idea if your work comp carrier would take responsibility is anything occurred from the trial, as they might. I hope this medication works for you.
(02-17-2016, 05:03 PM)California_Help Wrote: [ -> ]I disagree that stage I establishes a product or drug is safe. This is tested on a small group of people. After stage III the FDA will review the trial data and determine if the drug is safe and effective. Were you given the results of the last two trials including side effects?

I would not worry about your work comp claim being an issue if you are fine with possibly being responsible for any side effects. I was giving worse case scenario and have no idea if your work comp carrier would take responsibility is anything occurred from the trial, as they might.  I hope this medication works for you.

I'm familiar with clinical research.  Phase I is primary testing for safety, II is primary dose range and effectiveness vs the placebo, but also a further investigation of safety.  III is the large clinical trial.  I have read through the complete phase II trials, it includes the results and side effects.  You are correct, even many drugs that have been accepted are not 100% safe.  There is always risk.  

I'm not concerned with work comp not providing benefits for side effects, I would not expect them to take responsibility for that, I'm worried about getting kicked out of the trial because I had filed for work comp.