Arising from: DeVita (2008). The clinical trials system is broken. Nat Clin Pract Oncol 5: 683 doi:10.1038/ncponc1263

The recent editorial by Dr DeVita Jr, decries the current US system of performing clinical trials in oncology because it is plagued by long delays due to overregulation. The rate of scientific and clinical progress—in particular in the new targeted therapies—has accelerated during the past few decades so that an average delay of 800 days to start a cancer trial, as documented by the NCI study of Ditts and Sandler, is now an even more significant delay than it would have been in the recent past. Dr DeVita proposes decentralizing the authority over phase I and II trials to NCI-designated cancer centers, which would remain subject to FDA and NCI oversight. This seems like a suggestion that would greatly accelerate the pace of the trials without compromising the safety of trial subjects.

Delays in clinical trials translate into delays in patient treatment and ultimately, into avoidable disease progression and premature death for cancer patients who can't, and shouldn't be made to wait. If decentralizing authority would truly accelerate phase I and II trials and permit small modifications desired by the doctors who design and perform the trials, the faster availability of results and the earlier initiation of phase III trials would potentially benefit hundreds of thousands of cancer patients every year.

Dr DeVita's editorial states that “...most of these regulations have been imposed...by the US Congress in the name of patients' safety.” While the protection of trial subjects remains of paramount importance, surely every effort should now be made to eliminate these delays.

As a cancer patient I have been very fortunate to receive cutting-edge treatment by participating in and benefiting from recently concluded clinical trials. I have no doubt that I am alive today as a result. Cancer patients diagnosed a year or two earlier than I missed the chance to receive the up-to-the-minute treatment that I received. Cancer is a tough enough adversary; regulations designed to protect patients should not be permitted to cause such prolonged delays. I believe Congress should revisit this issue and closely examine the obvious merit in Dr. DeVita's suggestion.