Dr. Kennedy Readings 9/19
Three things I found interesting:
1.) I think it is interesting that the Clinical Path Initiative is including the aspect of "establishing standards for clinical trial data and its management; fully automating trials data and its management; improving the clinical trial quality management system; and modernizing FDA oversight of the clinical trial process". I believe this because of my research recently on the Clinical Trial Data Management Services which is an industry on the rise and could be used in this factor. If the FDA potentially made it mandatory for clinical trials to have a CTMA system for their trials, if would improve trial safety and efficiency as well as both the healthcare and CTMS industry.
2.) I find it interesting that the FDA Critical Path article stated that one debilitating factor for drug development is the fact that so much information is stored but yet not all of it is accessible for potential drug development because it is not generalized. It says that the "FDA holds the worlds largest collection of animal test data and correlated human trial data but most of the information is unusable in its current form, except to document a specific development program." This shows that some of the tools needed to improve the drug development process have been in our hands but are not transcribable or in a non-standardized form.
3.) I find it interesting that when it comes to tough disease fields such as AD, CNS, or cancer they can go years and years without any progress despite the number of compounds and lead optimizations that occur. The article states that in terms of AD, from 2002-2012 about 244 compounds were entered into clinical development and yet only one of them achieved regulatory approval which means there is a failure rate of 99.6%. With this is mind you could imagine how difficult it can be as a clinician seeing such failure in your daily hard work. Oddly enough later in the article it said that when a drug or medicine comes up in one of these fields usually it does not work within regulatory guidelines. So with this, in a way, developers and regulatory officials work together to devise a plan that will satisfy regulatory needs. This makes me worry that this can lead to 'beating around the bush' and skipping over certain guidelines because this is the only positive discovering coming out of the field in a long time.
Three questions I had:
1.) If the FDA approval process is to extensive after the third phase of clinical trials, why are some drugs being put to market that are causing so many issues in terms of patient safety and awareness of side effects?
2.) If animal testing does not prove 100% safety for human trials why are they still allowed or why are they allowing drugs to push through to the next phase?
3.) If it is common that in the drug development process trials look to minimize time to regulate approval or focus too much on obtaining evidence on drug efficacy rather than understanding drug action and testing the founding hypothesis, then why doesn't the FDA make it mandatory for trials to not skip over this event or create some punishment if they do?
1.) I think it is interesting that the Clinical Path Initiative is including the aspect of "establishing standards for clinical trial data and its management; fully automating trials data and its management; improving the clinical trial quality management system; and modernizing FDA oversight of the clinical trial process". I believe this because of my research recently on the Clinical Trial Data Management Services which is an industry on the rise and could be used in this factor. If the FDA potentially made it mandatory for clinical trials to have a CTMA system for their trials, if would improve trial safety and efficiency as well as both the healthcare and CTMS industry.
2.) I find it interesting that the FDA Critical Path article stated that one debilitating factor for drug development is the fact that so much information is stored but yet not all of it is accessible for potential drug development because it is not generalized. It says that the "FDA holds the worlds largest collection of animal test data and correlated human trial data but most of the information is unusable in its current form, except to document a specific development program." This shows that some of the tools needed to improve the drug development process have been in our hands but are not transcribable or in a non-standardized form.
3.) I find it interesting that when it comes to tough disease fields such as AD, CNS, or cancer they can go years and years without any progress despite the number of compounds and lead optimizations that occur. The article states that in terms of AD, from 2002-2012 about 244 compounds were entered into clinical development and yet only one of them achieved regulatory approval which means there is a failure rate of 99.6%. With this is mind you could imagine how difficult it can be as a clinician seeing such failure in your daily hard work. Oddly enough later in the article it said that when a drug or medicine comes up in one of these fields usually it does not work within regulatory guidelines. So with this, in a way, developers and regulatory officials work together to devise a plan that will satisfy regulatory needs. This makes me worry that this can lead to 'beating around the bush' and skipping over certain guidelines because this is the only positive discovering coming out of the field in a long time.
Three questions I had:
1.) If the FDA approval process is to extensive after the third phase of clinical trials, why are some drugs being put to market that are causing so many issues in terms of patient safety and awareness of side effects?
2.) If animal testing does not prove 100% safety for human trials why are they still allowed or why are they allowing drugs to push through to the next phase?
3.) If it is common that in the drug development process trials look to minimize time to regulate approval or focus too much on obtaining evidence on drug efficacy rather than understanding drug action and testing the founding hypothesis, then why doesn't the FDA make it mandatory for trials to not skip over this event or create some punishment if they do?
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