Topic: Would love your input on clinical trials

On June 2nd, I will be a DIA (Drug Information Association) Annual meeting Lead Speaker in a session focused on: Optimizing Trial Feasibility by Leveraging Electronic Health Record Data and Engaging Investigators and Patient Advocacy Groups

I thought to enlist your help with the hope that you will share with me some of your thoughts on the subject of clinical trials.  Who suggested the trial to you?  Why did you enter it?  What are the difficulties you encountered in regards to participating in the trial? 
Consent form – who explained it - do you understand the protocol?
Participation in trial:  difficulty in accessing location?  Additional finances incurred?  Insurance issues?  Lack of communication with physician?  Are your needs met in re: to side effect control?  Are you informed about the endpoint of clinical trial? 
And, many more questions and complaints you may have – I would love to know.

I value your input and look forward to hearing from you. 
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Would love your input on clinical trials

Hi Marion,

Many thanks for this and I look forward to hearing how it all goes. I saw this here on the news yesterday and although not CC related I thought it could be relevant and something that may be of interest to you for this meeting.

Basically it concerns age restrictions for access to clinical trials and a teenage girl was refused access to a trial here in the UK before she turned 18. She  was admitted to the trial when she turned 18 but was refused access to it by the company running the trial.

"Her family says she was told last September, when she was 17, that she was too young to take part, and that her participation could "jeopardise [her] safety and the integrity of the trial data"."

http://news.sky.com/story/1083643/mums- … ncer-drugs

As I said, not CC related and perhaps something that may not be of use for you here but thought I would mention it in case it was.

Hugs,

Gavin

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: Would love your input on clinical trials

Gavin….it is somewhat of a catch 22 situation:
Adolescents and young adults between the ages of 15 and 39 and the elderly continue to lag far behind when it comes to clinical trials participation.  Therefore; there is little information in re: to how (in this case) younger people react to certain therapies. Different factors could influence how their bodies metabolize the chemotherapy and ultimately effect the cancer and the possible side effects.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Would love your input on clinical trials

Marion: I wish I was farther along in the trial I am participating in. So far, I had trouble getting approval for Fox Chase itself for testing, since my "preferred" (not my preferred, but the insurance co) hospital is right here... Finally got approval. As far as I know, the drug co. is paying for the trial... I guess I will find out, but not until mid June. Getting approval was tough. I got my case manager involved and she went to one of the top doc guys who has been an onc and understands the problems with getting the correct care. He overrode the denial. Hopefully I don't have to go through that again.
And 7 days in I have no side effects. Unfortunately, I won't know how well it's working until mid June.
My new onc suggested the trial to me. It is aimed at patients (15 of them cc) that have had the approved treatment plans, with either no success or who had to stop because of side effects. Since I fit the criteria, I'm in. She spent quite some time explaining to me. The woman running the trial also went over the "rules and regs" of the trial.
It will continue (as I understand) as long as it works for me with no major side effects or damage to other bodily functions. As long as the cancer cells either shrink or stay stable, I can continue the trial. At least that's how I understand it.

Is this what you wanted?

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: Would love your input on clinical trials

Kris....thank you; this is perfect. At this point you are not sure as to whether the insurance pays for all occurring medical expenses such as CT, MRI, blood test, etc?
This trial has to work for you, dear Kris.  I am not allowing my mind to think otherwise.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Would love your input on clinical trials

At this point, I believe the drug company is now paying... But who knows? If the insurance co. has to pay for scans, etc., I'm hoping its no longer a problem. Of course, the company I used to work for is shopping out the insurance coverage, so I sure hope it's still Aetna. Not that I like Aetna, but I've been through all the BS with them to get stuff covered. The paperwork is kind of unclear: I'm sure Eli Lilly is paying for the drug, pretty sure they are covering all the blood work... And I was told they were paying for everything, but I'm not sure after reading the paperwork. It does NOT say they are paying for the scans every 2 months.

And, yes, Marion, I agree. I believe the trial drug is going to work. I believe it will shrink and hopefully eradicate the cancer. But, failing that, I will settle for "stable"!

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: Would love your input on clinical trials

Kris...two thumbs up.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER