Access to Clinical Trials

I went up to Boston this past Monday in anticipation of a visit to the Dana-Farber Cancer Institute to see Dr. F. Stephen Hodi on Tuesday. Coincidentally, that day the New York Times, published an article by Gina Kolata, "Lack of Study Volunteers Hobbles Cancer Fight, (NYT, August 3, 2009) the gist of which was that "There are more than 6500 cancer clinical trials seeking adult patients" .... (but) ... "More than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result, ..." The entire article is worth reading.

I shared the article with a friend and cancer co-warrior. I'm repeating her response for anyone thinking about finding or struggling to get into a trial:

"Maybe they ought to make it easier to get into trials."

"It should be patient choice if you want a study drug over the "gold standard", which only has a 7% response rate and horrendous side effects. But you have to be debilitated first by the gold standard and watch your disease progress before they let you into the majority of trials."

"They need to make trials more attractive."

"A lot of new drug trials won't let you increase your dosage as new safety and efficacy info comes through. So, as in my case, women all over the world are getting twice the dosage for parp inhibitors that I get and I'm stuck at this dose because I'm in a trial)."

"They also need to make information from the trials more accessible to the patient."

(In a trial involving PARP inhibitors)..."Why shouldn't I be told if there is any PARP inhibition going on in my body. They've got my blood. They could tell me. If the drug isn't doing anything I should know early on and not wait weeks for scans to tell me my cancer is progressing."

"Right now, trials are largely for the benefit of the researchers and pharmaceuticals and patients 15-20 years down the road. They need to make trials for the people who are in them. We're already taking risks and undergoing far more exams and scans than normal."
As a statistician/researcher myself, as well as a cancer patient, I understand the basis for the tension between the need for clean research and the needs of the patient. The sicker I get the less sympathetic I am toward the research needs - no surprise there. Because of this, the European "laxity" in the limitations to drug access becomes more appealing - assuming it's not sloppiness or greed-driven - of course, I believe babies are found in a cabbage patch and there's a pot of gold at the end of the rainbow, too - Not.