This week in the Journal of Clinical Oncology, a group of clinical researchers and specialists in management science took it upon themselves to study and report, in depth, the processes that the National Cancer Institute (NCI) and its developmental clinical trials branch, the Cancer Therapy Evaluation Program (CTEP), use to design and approve new clinical trials for promising anti-cancer agents. There has been a general consensus for years that new clinical trials were taking way too long to move from concept to reality, and they wanted to look at the possible reasons behind it.
As you probably know, clinical trials are research studies that prospectively enroll patients with a particular disease state (for example, metastatic NSCLC) to an experimental treatment that is hoped to be better than the standard treatment. The most important trials are the phase III “randomized” trials, in which patients are randomly assigned to either the new treatment or the current standard treatment. This is done to balance out any random elements of the patients so that both groups are relatively evenly matched for things like age, sex, performance status, etc. This type of trial is what was used to bring drugs like Avastin (bevacizumab) into common use.
For example, say drug X shows great promise in an early phase trials, and I want to design a phase III trial to bring this great new drug to approval by the Food and Drug Administration (FDA). I write to CTEP with an idea to test this drug, in combination with, say, Tarceva (erlotinib) in a phase III trial compared to Tarceva alone in NSCLC patients. I send in the concept, and CTEP then initiates its review process to determine if this is something they want to fund.
Here is the general outline of the process. It begins with review of the concept, and if the concept is approved it moves to the protocol development group. Once the protocol is finished, it goes to an institutional review board (IRB; whose primary function is patient safety) as well as some other administrative reviews, before moving to activation.
Sounds straightforward, doesn’t it? Ha!
