[animalci]

Trial Summary

An estimated 86 client-owned pet dogs will be enrolled in this Phase II study. The study is a randomized, investigator-masked, placebo-controlled study in dogs with measurable soft tissue sarcoma. The randomization of active Test Article to placebo will be 1:1 with a crossover option for dogs in the placebo arm that have disease progression.

The first eight (8) dogs enrolled in the study will be assigned to receive active Test Article in an open label manner and will have blood samples collected over a period of 24 hours post treatment.
Once enrolled, study patients will be evaluated at Days 14, 28 and every 28 days thereafter until tumor progression occurs.

Trial Support and Funding

Study drug, diagnostic tests, and follow-up exams will be paid for by the study sponsor. In the event that side effects are noted and attributed to the study drug, the study will pay for medical management of the side effects.

For more information please fee free to post comments, ask questions, or visit animalci.com

 

[Pointgold]

Who is the study sponsor, please?

 

[animalci]

Due to confidentiality reasons. We are not at liberty to disclose who the sponsor exactly is because this is a public forum.

As a pet owner, participating in a clinical trial provides you with an opportunity to help your pet when conventional treatment options are either not effective or not accessible. Your participation may provide immediate benefits for your pet and will provide more effective treatments in the future for other pets with serious diseases. We have a vast network of veterinarians that we work with.

An ACI network veterinarian will determine on a case-by-case basis whether entering your pet into a clinical trial is in the best interest of you and your pet.

Should you have questions please feel free to email us directly at [email protected] You may also email the study coordinator who is in charge of this membership at [email protected]

 

[animalci]

Do you have a pet that you would like to consider for this study? I would be more than happy to speak with you directly if so.

Please feel free to contact me at [email protected] or feel free to contact us at [email protected]

 

[tippykayak]

Who is the study sponsor, please?

My guess is a pharmaceutical company. I would call one of the animal hospitals participating, like Friendship Hospital for Animals at (202) 363-7300.

 

[animalci]

Please feel free to contact Friendship Hospital for Animals. They have a great group of Veterinarians that we work very close with. They are one of our network members so yes, they would be able to provide more information about what we do as well. Our network of members include some of the top Oncologist, Specialty and Primary Care Veterinarians across the nation.

 

[Pointgold]

Is Animal Clinical Investigations a lobbying firm?

 

[Pointgold]

Do you have a pet that you would like to consider for this study? I would be more than happy to speak with you directly if so.

Please feel free to contact me at [email protected] or feel free to contact us at [email protected]

No, I do not. But, I sure would want to know a lot more before I encouraged anyone who does to allow their pet to be used for research studies utilizing Golden Retrievers if the GRCA doesn't even know about it. Even if "medical management of side effects" caused by the study drug is paid for.

 

[animalci]

Is Animal Clinical Investigations a lobbying firm?

No. We are what you call a Contract Research Organization (CRO). A CRO is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices).

 

[Pointgold]

No. We are what you call a Contract Research Organization (CRO). A CRO is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices).

Ahh. Well, good luck. I will continue to encourage Golden Retriever owners to participate in the many GRCA and Morris Animal Foundation funded research programs.

 

[Pointgold]

No. We are what you call a Contract Research Organization (CRO). A CRO is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices).

This is right from Wikipedia.

"A contract research organization, also called a clinical research organization, (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices).[1]


CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.[2]"

 

[Florabora22]

I know nothing about ACI so I'm not condoning or condemning what they do, but I feel like this whole thread has turned into mini witch hunt. Isn't it easier to lift a definition from a (relatively) reliable source than craft your own? Sometimes it is. I've seen other users on this forum do similar things and we don't question them. I think it's great that you're trying to get more information on this vender, but... I don't know, there could be a less accusatory tone you could take with it.

 

[animalci]

Wikipedia is correct on what a CRO is. Animal Clinical Investigation falls under this branch. We conduct clinical trails with our network members (Specialty Hospitals around the nation). We are partners with many Veterinarians who specialize in Oncology, Specialty and or Primary Care.

We aim to provide pet owners with options for pet owners whose pet may face a serious illness or condition. By partnering with a vast group of very skilled Veterinarians we are able to not only conduct studies under very strict ethical codes but with compassion.

 

[animalci]

We are here to answer questions. Many people have questions as to who we are and what we do. All our studies are voluntary and if one chooses to participate he/she has the option to withdrawal or back out at anytime.

This thread was started because Soft Tissue Sarcoma is very common amongst dogs. We are simply here to provide information to pet owners and give them other options to potentially improve the life of their pet.

This is just one of the many studies that we conduct. As you may know, hip dysplasia is very prevalent amongst Goldens and Labradors so we aim to seek out pet owners whose pet have this condition to provide information about Hip Dysplasia and seek their participation. The choice to participate is completely up to the pet owner.

 

[Oaklys Dad]

Sorry you have been met by skeptics but to our close knit community we are very careful. It would be a great help if you could give us a LOT more detail as to what your organization does and how it can help our golden retrievers. I can't help but think our goldens will be lab rats based on what I have seen you post so far. : I'm sure that is not the case but you have come on a little strong and dry for our crew. If you can, please give us a little better introduction into what exactly what you do and what you can do for our beloved pets. I've followed your posts so far and I'm just totally up in the air as to what you do and why you do it.

 

[Pointgold]

I know nothing about ACI so I'm not condoning or condemning what they do, but I feel like this whole thread has turned into mini witch hunt. Isn't it easier to lift a definition from a (relatively) reliable source than craft your own? Sometimes it is. I've seen other users on this forum do similar things and we don't question them. I think it's great that you're trying to get more information on this vender, but... I don't know, there could be a less accusatory tone you could take with it.

The intent is not to be accusatory. As for "lifting" a definition from any source, rather than crafting their own, one would think that an organization such as ACI would not have to, or, would at least credit the source.
Sorry, but when someone is asking for dogs to be used in clinical studies or other research, it is not unreasonable to question who sponsors are, etc. To be told that these things cannot be disclosed is a concern for me. Of course participation is voluntary, but why would anyone consider allowing their pets to be used as "guinea pigs" without being fully informed as to who was involved? I have always encouraged Golden owners to participate in and contribute to research programs/studies pertinent to the health issues that we see in the breed. The GRCA has been very involved in, and major funders of some of the most important studies undertaken, and has always been very open about informing members of all the details. Only reasonable.

 

[Pointgold]

Not that the Evil PG said "guinea pigs" and not "lab rats" I started to, but practiced some restraint.

 

[Finn's Fan]

In human clinical trials, should you choose to particpate, you know a great many more details about the particulars, including which company is trialing the drug. I agree with PG that there are more particulars that need to be available from ACI. Personally, I've allowed Morris Animal Foundation to cheek swab Finn for several studies, but all the parameters and info was made clear to me before I participated.

 

[LibertyME]

When people are facing a crisis with their beloved pets and someone dangles a bit of hope in front of them...some will grab for it out of desperation.


I guess I don't understand why you have no problem having us call individual clinics to gather info, but we cant get it directly from the source.

I fully understand that research (and clinical trials) are often a part of advancing treatment plans....but for pity sake...let me have the info when my head is clear and my heart is not heavy with the emotions of my dying dog so I can research the companies involved.

 

[Pointgold]

When people are facing a crisis with their beloved pets and someone dangles a bit of hope in front of them...some will grab for it out of desperation.


I guess I don't understand why you have no problem having us call individual clinics to gather info, but we cant get it directly from the source.

I fully understand that research (and clinical trials) are often a part of advancing treatment plans....but for pity sake...let me have the info when my head is clear and my heart is not heavy with the emotions of my dying dog so I can research the companies involved.

CRO's make huge profits.
Profits definitely take priority over compassion.
Contract Research Organization (CRO)