We are international
Donate
• advocacy   TEXT SIZE   


Early Approval - National policies and procedures for early approval of new treatments need to be reformed and streamlined.
01.28.10

Principle 4 states that:

“National policies and procedures for early approval of new treatments for cancer and other deadly diseases need to be reformed and streamlined.”

Specifically:

  • In the interests of patients with disorders with a 5-year survival rate of less than 50 percent, the emphasis should be on proof of effectiveness and early availability, with full disclosure of risk for adverse effects.

  •  A more efficient mechanism is needed for early approval of off-label uses of already approved medications, possibly based on registry data, actual clinical practice, peer reviewed studies and NCCN guidelines without the expense and delay of complex and time-consuming clinical trials.

Click here to read the original Cancer Patient Statement of Principles in full.


 related articles