What process does the FDA follow when determining whether to approve a drug?

FDA approval doesn’t actually take as long as most people think.  In a recent blog post, http://www.cancer-clinical-trials.com/2012/07/waiting-for-new-drug-to-be-approved.html we discussed the fact that FDA approval, at an average of 322 days, is actually a little faster than approval in Europe and Canada.  That’s not to say it’s quick, but it does not take years.  What takes a long time are all the studies necessary to collect the information the FDA requires to consider an application.  The FDA uses the “safe and effective” standard.  Effective means that cancer patients benefit in a meaningful way.  This often involves living longer, being cured of cancer, or experiencing quality of life improvements.  The FDA reviews all of the clinical trial data in detail to determine if these standards have been met.  This review takes several months.  While we all want cancer drugs to come to market as quickly as possible, it is also worth remembering that the FDA is held accountable when a drug is approved that later proves unsafe.  It’s a balancing act between moving quickly and dotting the i’s and crossing the t’s.

For more questions and answers about clinical trials, visit the Talk about Health website.
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

What are the next steps after being accepted into a clinical trial?

Acceptance into a clinical trial begins with the consent process.  Risks and potential benefits, as well as other options are explained by your physician or research nurse and also presented to you in writing in the Consent Form – typically a lengthy document.  Once you have been fully informed and have consented to the treatment, the next step is to complete the pre-treatment evaluation.  This includes a visit with your doctor or nurse, blood tests, scans to determine the extent and location of your cancer, and potentially other tests mandated by the study.  At this stage, it is still possible to be “uninvited” from the study.  This happens if a test result shows that you don’t meet all the criteria to safely participate.  Once the pre-treatment evaluation is complete, the study treatment begins. 

For more questions and answers about clinical trials, visit the Talk about Health website.
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

How is being in a clinical trial different from getting regular treatment?

In many ways, being in a clinical trial is similar to receiving standard treatment.  There are regular visits, blood tests, scans, and a cancer drug – or several – are given on a set schedule.  Side effects are monitored and adjustments are made to minimize them.  There are some differences.  As much as cancer treatment programs tend to be fairly rigid and structured, clinical trials are even more so.  Everything that happens follows a precise recipe.  There may be additional tests or surveys to fill out that would not be a part of standard care.  Some of these may include much more extensive monitoring – for example serial blood draws to measure drug levels in detail during a 24 or 48 hour period.  It is also likely that less is known about the drug or drug regimen that is being tested than standard care.  Outcomes in cancer treatment are never certain, but participating in a clinical trial involves a greater degree of the unknown.  

For more questions and answers about clinical trials, visit the Talk about Health website.
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker