Editing Cancer vaccine (section)

== Recommendations ==
In January 2009, a review article made recommendations for successful oncovaccine development as follows:<ref>{{cite journal | vauthors = Johnson RS, Walker AI, Ward SJ | title = Cancer vaccines: will we ever learn? | journal = Expert Review of Anticancer Therapy | volume = 9 | issue = 1 | pages = 67–74 | date = January 2009 | pmid = 19105708 | doi = 10.1586/14737140.9.1.67 | s2cid = 26656379 }}</ref>
* Target settings with a low disease burden.
* Conduct randomized Phase II trials so that the Phase III program is sufficiently [[Statistical power|powered]].
* Do not randomize antigen plus adjuvant versus adjuvant alone. The goal is to establish clinical benefit of the immunotherapy (i.e., adjuvanted vaccine) over the standard of care. The adjuvant may have a low-level clinical effect that skews the trial, increasing the chances of a false negative.
* Base development decisions on clinical data rather than immune responses. Time-to-event end points are more valuable and clinically relevant.
* Design regulatory into the program from inception; invest in manufacturing and product assays early.