Abigail's Alliance

On my recent post about clinical trials, commenter Steve Walker wrote, "The Phase III trial is being run primarily to satisfy the rigid, formulaic and in many cases scientifically obsolete requirements imposed by the FDA's Office of Oncology Drug Products for most cancer drugs...." 

Is the randomized clinical/controlled trial (RCT) obsolete?

The current design of trials dates back half a century, around the time Watson and Crick first proposed the double-helix structure of DNA. Clearly our understanding of the biology of cancer has grown dramatically. Yet the 3-phase trial process has remained the same.

Advocates argue that the notoriously slow and expensive RCT unnecessarily keeps patients who have no  treatment options from trying novel, science-based treatments that might rescue them. A separate but related controversy revolves around patients' right to try treatments that are still investigational. 

My questioning led me to Abigail's Alliance, an organization committed to "helping create wider access to developmental cancer drugs and other drugs for serious life-threatening illnesses."

Visit the website to read how the founder responded in a congressional hearing when asked if he was angry at the pharmaceutical industry: "We do not need any enemies regarding better access to developmental life saving drugs. We need the help of the multi-billion dollar pharmaceutical industry, the U.S. Government, and others to help solve this problem."

As a Healthy Survivor, I'm going to learn about and push for better ways for researchers and legislators to evaluate and approve new science-based therapies.  

 

Comments

[Transcription Service]

Very interesting.

[Brainstorm]

Clinical trials provide necessary information about new drugs or new treatments of cancer, but it must be done with the task of the blessing of mankind not for business purposes