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Clinical Trials: they are not designed only to be a “last resort”
Pancreatic Cancer | Last Active: Sep 13 7:47am | Replies (42)Comment receiving replies
The individuals who did benefit from the drugs (RPI-613 and SM-88) which did not go on to becoming FDA approved remained on those drugs under a provision of the FDA called “Compassionate Need”. At the conclusion of the trail, the principal investigator of the trial writes an Individual Patient-Investigational New Drug (IP-IND) protocol and sends it to the FDA. The review is done within 24 hours of submission. After FDA approval, the developer of the drug provides it at no charge to the patient for as long as it works. So no patient that benefitted from an investigational new drug is deprived.
In the trial I was in, my drug was not submitted to the FDA for approval. The target of overall response was not achieved. I had an exceptional response to the drug and my oncologist wrote an IP-IND protocol submitted to the FDA which approved it in less than 24 hours. The drug manufacturer has provided the medication to me for almost 10 years and continues to do so. In return, data from my diagnostic tests and exams is shared with them. A new entity has purchased the rights to the drug so there is the possibility they could do further improvement of the drug and apply to the FDA for approval to market it in the future.
Replies to "The individuals who did benefit from the drugs (RPI-613 and SM-88) which did not go on..."
I'm in a clinical trial at the NIH in Bethesda, MD for the drug Olaparib ( or Lynparza) for my acinar cell pancreatic cancer. Started early June and the drug has had a positive effect on the remaining CT visible tumor on my liver. I asked the Dr. in charge of the 2 yr. trial that if I continued to see progress until the end of the trial, and that if Olaparib had still not been approved by the FDA for acinar cell pancreatic cancer treatment, would I still be able to get the drug? The Dr. told me that she could write some type of letter to the VA, (I'm a disabled veteran), that would allow the VA to issue me the drug. So, as I understand your post, she would actually send the IP-IND letter the FDA on my behalf? I'm just trying to understand the process before I head back up the NIH on Sept. 24. Thank you for your time and any input.
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I'm glad you've had such good results. Your story had offered much inspiration and hope. It is shocking to learn that there are actual drugs that have been effective for younger and/or healthier patients but are denied because the drugs don't work as well in older and/or sicker patients. With this kind of criteria, I don't see Biden's Cancer Moonshot program getting off the ground. I truly wasn't expecting this level of ethical & moral compromise in scientific research and product development. At least the drugs you are on have the possibility of being developed elsewhere. Considering that private research is piggy-backed on public research and often publicly-privately financed, I question the practice of private companies monopolizing or holding back scientific advances.