According to the research published in the JAMA Internal medicine on 19th October 2015, clearly, support the statement that the US drugs controller or the FDA might be approving the number of expensive and harmful cancer drugs that may fail to live up to the expectations and also don’t enhance the overall survival rates. It has been concluded through the study that the cancer drugs approved by the FDA are based on the point of surrogate endpoint and also less based on the component of overall survival.
Hence the surrogate endpoint implies a marker or a sign which can be utilized as a part of the place of another to tell if a particular treatment works or not. Since due to the use of surrogate endpoints in the clinical trials, it allows the prior endorsement of new medications to treat serious or hazardous ailments as cancer whereas the surrogate endpoints are not the evident markers or the indications of concluding that how well a treatment functions.
The overall survival implies the period of time from either the date of analysis or the beginning of treatment for an illness, like cancer, that patients determined to have the ailment are as yet alive. Whereas in the clinical trials, calculating the Overall survival rate is the indication to check on how the new approach of treatment works towards the ailment which is commonly known as OS.
So the whole analysis has been conducted by the specialists from the US National Cancer Institute and the Knight Cancer Center at Oregon Health and Sciences University, who has dissected that the overall survival information for cancer drugs endorsed by the Food and Drug Administration (FDA) from January 2008 to December 2012 were the approvals which have been made upon the clinical trials reporting the surrogate endpoint, such as a response rate or progression-free survival (PFS).
Hence, the concluded analysis was also incited through the criticism of the US government accountability office in the year 2009 and which reported that the FDA had neglected to authorize post-advertising contemplates for the surrogate approvals.
The researchers, Dr. Prasad and Dr. Chul Kim from the National Cancer Institute had performed a literature review to discover that the out of 54 approved cancer drugs which were also provided with a marketing authorization in the lap of 5 years research, that only 36 cancer drugs endorsed based on a surrogate endpoint from January 2008 till December 2012.
Whereas after an average follow up of around 4.4 years on the 36 approved cancer drugs o the basis of surrogate endpoint, it has been found that 5 of those drugs have shown the benefits of Overall survival in the further subsequent studies, where 18 of those drugs have shown no sign of overall survival benefit and the rest 13 drugs have shown the sign of some unknown Overall survival benefits which are not researched till time.
Therefore almost around 66% of the new cancer disease drugs have been appeared to be approved by the FDA in the view of the surrogate endpoint, and out of them, half of these eventually shows no signs of OS rate and while a greater part of the other half keeps on having obscure OS benefit rate which has been discovered after the subsequent research of many years.
Hence, it is concluded through the published research or analysis from JAMA internal medicine that the overall survival rate is also the equally essential element which should be considered with the surrogate endpoint as it is the point which clearly shows the sign of improved survival and also improves the quality of life of the cancer patients through the effective cancer drugs.
Thus, this article was written in context with the published research on “cancer approved drugs on the basis of a surrogate endpoint and subsequent overall survival through continues 5-year analysis of the US Food and drug administration on such approvals” mainly consists or proposing the points as:
– The severity of the illness should be considered before approving the drugs.
– The clinical trials should be successfully conducted on the parameters as “how serious, dangerous or life-threatening the cancer is”.
Hence, it is recommended that the criteria for approving the new medicines should be revised by introducing a new approach.