Why biomarkers are important for drug development

[Guest guest]

The FDA is currently considering the feasibility of using PSA as an

alternative endpoint for clinical trials.

Biomarkers can also short circuit the current 'gold standard' clinical

endpoint for cancer trials, which is survival. Suppose a new therapeutic

under development for brain cancer has a ten percent clinical response

rate in phase 2 clinical trials; a large randomized phase 3 study would

need to be done to demonstrate clinical benefit. But if parameters from

the patient's tumor or serum were developed to help predict response,

the resultant phase 3 would be significantly different. The phase 3

clinical trial would use these parameters as inclusion criteria and the

response rate would now hypothetically be 45 percent. The change in

response rate would allow for a significantly smaller, quicker and

cheaper trial- benefiting all. In many cases, patients and physicians

would be willing to take the risk of using biomarkers instead of

survival for clinical trials because of the immediate need for new

cancer therapeutics.

Advocates should read the entire article at:

http://www.fastercures.org/sec/essay_agus

Kathy Meade

Arlington Educational Consulting

http://www.vapcacoalition.org/

http://www.naspcc.org/

phone

fax

Contact your legislators. Ask them to fully fund cancer research.

And the trouble is if you don't risk anything, you risk even more.

a Jong