The upcoming 2015 Cholangiocarcinoma Foundation Conference
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Not always does it take ten years for a drug to be approved and applied to patients. The FDA has in place 4 distinct application processes for a drug showing promise in early testing. In order to speed the process of application (which can be lengthy – perhaps 1 year or more) drug companies must fit specific criteria. But, the data must clearly show advantages over a drug already in use or potentially could be life saving. The rules and regulations are stringently scrutinized. I believe that in the current state, we can expect drugs to come to market within 5 to 6 years (for our cancer.) There have been instances where a drug showed such overwhelming positive response that a phase I speeds to a phase II clinical trial and if it continues to show similar results, it can be brought to the patient population significantly faster. But, as a whole, we must count on 5 to 6 years (at least) as the stages of clinical trial take up the majority of time.
Here is a link explaining the 4 different applications drug companies must file with the FDA:
http://www.fda.gov/ForPatients/Approvals/Fast/default.htm
Hugs
MarionA very slow speed process it is getting drugs approved is it not.But then again it has to be thorough doesn’t it and that takes time. Think that the speed that they are trying to come up with drugs to fight ebola is remarkable but that is hopefully a one off situation. It can take the best part of a decade can it not to get drugs through all the R&D, trials and finally approved for patients ?
Hugs,
Gavin
Research medical studies are important, but ultimately the patient will benefit only (if and when) these studies are validated by clinical trials. Gavin or I or anyone else places these articles on this site so that people are aware of ongoing research to this disease. If indeed the research brings about further developments then this type of information may be of importance to us. That is not to downplay the information rather; we need to put it in perspective as to where the benefit lies.
In order to conduct a clinical trial, the pharmaceutical company must prove validated data that a drug should be introduced to the patient community. Stringent rulings are in place and no deviation is allowed; only 1 in 6 drugs are approved by the FDA.
Only then can this drug applied to the patients community beginning with a Phase I research study.Therefore, it helps us to know about new developments, but we can only give it credence when successfully applied to the patient.
Hugs
MarionNot sure if the Conference is the right place to ask this, but …
There is a wealth of information out there and new info is coming out almost daily (thanks Gavin) from studies and trials. What is/can be done to coordinate this info to focus/prioritize new research? Resources are limited, so we have to work smarter, not harder. We have to minimize duplication of efforts and continue to open new doors. (“To boldly go where no one has gone before.” Sorry – once a Trekkie, always a Trekkie.) Pharmas are looking for payback. That’s fair, since they are not non-profit organizations. But they have to be factored into the big picture.
Duke
Marion
It doesn’t look like Dr. Roongruedee Chaiteerakij or anyone from Dr. Lewis Roberts’ group is going to make a presentation on what they have learned from the information many of us provided. In fact, I have heard nothing since the one webinar. What are their plans for the future release of any info?Duke
Thanks for that Marion, very exciting indeed! Looking forward to hearing all about this and all of what will be ahppening in Feb next year as well. I always like February! Big line up at the think tank and i hope that you get your presentation ready for your talk on day 2!
Hugs,
Gavin
PS – Hope there will be lots of pics this year of everyone!
We are busy behind the scene preparing for the upcoming annual CCF Annual Conference.
Clinical physicians, researchers, palliative care nurses, pharmaceutical and government representatives, and patient advocates will gather for what I like to consider The Annual Cholangiocarcinoma Think Tank.http://cholangiocarcinoma.org/misc/2015-cholangiocarcinoma-foundation-annual-conference/
We will pass on more information and updated attendance listing within the ongoing months
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