Description :

Clinical trials to test new cancer treatments involve a series of steps called phases if a new treatment is successful in one phase it will proceed to further testing in the next phase during the early phases phases 1 and 2 researchers figure out whether a new treatment is safe what its side effects are and the best dose of the new treatment. Ratain mj sargent dj optimising the design of phase ii oncology trials the importance of randomization european journal of cancer 2008 to appear simon r thall pf ellenberg ss new designs for the selection of treatments to be tested in randomized clinical trials stat med 1994 13 5 7417 429. The randomized phase ii trial is a well known platform for testing the efficacy of novel agents in oncology with the potential of minimizing some of the pitfalls inherent in the single arm phase ii design 7 such studies fall into three main groups including randomized selection design pick the winner in which the best of two or more . The pipeline of immunotherapies is particularly active and includes almost 300 molecules with 60 separate mechanisms being evaluated in phase i or phase ii clinical trials while many efforts are in place to accelerate the time it takes to bring a new cancer medicine to patients the 2017 new drug approvals had a median time since patent filing . Some drug makers may conduct their own phase iv clinical trials they may do more research to get fda approval to use the drug in a new way such as for another type of cancer the fda also monitors the safety of drugs currently on the market they do this to make sure that drug makers report any new or serious side effects