Sponsors
Drug Developers and CROs
Drug development is too expensive, and takes too long, we all know that. And up to now, the system has made it so hard, so expensive, and so time consuming to get credible, ethically sourced, meaningful data. Right to Try changes that.
Whether you are treating “screen fails” from your existing trials, or using Right to Try eligible patients that Access Hope CRO recruits through its unique opt in filtered database, Right to Try gives you the opportunity to collect meaningful real world data from patients, see that data in real time, and at a fraction of the cost of randomized clinical trial data. It’s time to stop throwing away all the data from so many patients who want to participate in your drug development program.
BENEFITS FOR SPONSORS & CROs
The FDA is prohibited by law from using any data from a right to Try program to stop or delay any approval with extremely rare safety exceptions. Right to Try allows you to control how that data is used and who it is shared with.
The Act provides heretofore unavailable immunity from lawsuits throughout the entire ecosystem as an inducement to improve access. There are exceptions for fraud and/or gross negligence.
Eligible patients must be “trial challenged” in some way, either by inclusion/exclusion criteria, or geographically. For Sponsors conducting clinical trials this offers a unique opportunity to treat “screen fails” and both deliver access to patients, and create meaningful data.
Treatment protocols require informed consent similar to FDA approved clinical trials. IRB’s are not required, but can be used at your discretion.
Physicians and other service providers can be paid under Right to Try, but patients can only be charged “cost” for the actual drug. In most instances it is assumed the drug will be provided at the sponsor’s expense as in a traditional clinical trial. However for companies that will require charging the cost of their drug in order to provide it, the law allows for “patient pay” programs. The point of the law is to encourage sponsors to participate, not to set up roadblocks and hurdles.
"It’s not that we have so little but lose so much"
~ Seneca
WHAT'S NEXT
Access Hope CRO works with drug developers and sponsors and CROs already running clinical programs in many different ways. We can do feasibility consulting on your portfolio to advise on programs that are Right to Try eligible and how and where they can be most productive in your clinical development path.
We can design and recruit and implement compliant Right to Try programs and custom Edata collection programs from scratch. We can also work with your existing CRO to supplement their clinical services to enable treatment of screen fails that you have already recruited yet rejected from your trials.
So whether you are a drug manufacturer, or a trial sponsor, or even a clinical CRO, if you are interested in finding out more about how Access Hope CRO can help you unlock the promise of Right to Try treatment programs, at scale, please contact us.
GUIDELINES
There are no limits to the number of patients that can be treated in an RTT program, and no “renewal” required after a year as with the FDA’s EAPs. There is no approval required from the FDA to begin treatment, nor FDA reporting requirements during treatment other than an annual accounting of the number of treatments provided and the indications the treatments were provided for, along with any known SAE’s, provided by the Sponsor.
The FDA is prohibited from using any data from an RTT program to stop or delay any approval with rare exceptions.
The Act provides heretofore unavailable immunity from lawsuits throughout the entire ecosystem as an inducement to improve access. There are exceptions for fraud and/or gross negligence.