Patients
Patients diagnosed with life threatening diseases, as well as their family and caregivers, expect and deserve honest, straightforward communication. At Access Hope CRO, we take this responsibility very seriously. We want you to understand Right to Try and to know exactly what we do and what we don’t do.
Eligibility
What does it take to be an eligible patient under the new Right to Try Federal Law? There are three (3) basic requirements:
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You have to have been diagnosed with a life threatening disease. This is any disease or condition that will likely prove fatal if the course of the disease is not interrupted.
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Your physician must certify that there are no FDA approved drugs likely to stop or reverse the course of the disease; and that you are (for any reason) unable to participate in an ongoing FDA approved clinical trial using the drug for your indication.
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Finally, to be an eligible patient you must be properly informed and sign an informed consent. The law allows for legally authorized representatives to sign the consent forms if the patient him or herself can not.
If you are involved in a treatment program that Access Hope CRO is managing, we will provide the forms required for both patients and doctors.
PATIENT BENEFITS
For patients with few if any treatment options, Right to Try offers access to experimental drugs with no risk of receiving a placebo or “standard of care” control treatment.
All drugs eligible for Right to Try use are also in an active FDA trial queue, and have already passed at least an initial safety trial.
The analysis of the risk vs the possible benefit for each patient is strictly a decision made by the patient and their doctor with input of course from the drugs’ manufacturer. There is no FDA submission or approval required for eligible patients to receive eligible drugs. It is up to the patient and their doctor and the sponsor to agree that the eligibility requirements have been met. The law was intended to put this decision making responsibility in their hands.
ADDITIONAL RISKS
To induce drug developers to make their drugs available under Right to Try, the law grants them immunity from lawsuits. Almost all of the State Right to Try laws do the same thing.
There are exceptions to this immunity of course, for things like gross negligence or outright fraud, but you should understand that if you decide to be treated with an experimental drug under the Right to Try pathway you will be giving up some possible rights to sue various parties involved if things go wrong.
TREATMENT
There is no approval required from the FDA to begin treatment under Right to Try. Once you have been properly informed of the risks and your rights and consented to the treatment, treatment can begin.
You can not apply for a Right to Try treatment by yourself. The law requires that a physician certify your diagnosis. Depending on the State you are being treated in, you may need two physicians to confirm this diagnosis or even a specialist. Your physicians also have obligations to talk to you about your available approved treatment options if there are any; and any available traditional clinical trial options.
If you are treated under a Right to Try program, you will receive the actual experimental drug, there are no placebo or standard of care control groups under Right to Try.
You will never be charged by Access Hope CRO for using our web portal. But you may be charged by Physicians and other service providers involved in a Right to Try program. It will differ greatly from program to program.
You may also be charged for the drug in a Right to Try program. Under the law, patients can only be charged “cost” for the actual drug, but physicians and service providers can and likely will charge their usual and customary fees.
In most instances the drug will be provided at the sponsor’s expense as in a traditional clinical trial, and in most cases the Sponsors will pay the physicians and service providers also. This will vary widely from program to program. If you are involved in a Right to Try program that Access Hope CRO is helping to manage, we will make sure that you are completely and fully informed of any and all costs you may incur in such a program.
"Once you choose hope anything's possible"
~ Christopher Reeve
What's Next?
OPT IN TO OUR DATABASE
Opting In: The Key to Finding if There’s an Appropriate Treatment for You
Right-to-Try legislation is requires a strict informed-consent procedure. All patients must know the risks before making their own decisions on whether to enter a Right to Try program, or not. We also believe they should be informed of potential costs. To comply with this policy, Access Hope CRO employs an opt-in policy prior to the discussion of any of our Right to Try clinical programs. This protects both the patient and the integrity of our programs. This means you must sign-up before you can receive any information on any Access Hope Right to Try programs.
When You Opt In, What Happens?
We have a three-tier, interactive-consent opt-in protocol. All information is protected under HIPAA, just as it would be at a doctor’s office. Step One consists of you submitting some basic information. It allows us to tell you (via email) whether or not we have currently have a Right to Try program for your indication.
If so, you may choose to move to Step Two, in which you share more information with us, enabling us to describe the program specifics, including potential costs.
If, after receiving that information, you wish to proceed, we begin Step Three: the formal patient information and consent program. Then, we schedule treatment. But nothing can begin without you taking the first step here.
Click on the link below so that we may contact you if we have a Right to Try treatment program that you may qualify for.