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What is the Benefit, Precisely?
March 02, 2011 – Debu Tripathy, MD
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What is the Benefit, Precisely?

We are retooling clinical trials, but are not sure that this will all work quite yet.

BY Debu Tripathy, MD
PUBLISHED March 02, 2011

Our readers are very astute. Following publication of an article in CURE’s Fall 2010 issue on new therapies for chronic myelogenous leukemia (CML), we were corrected on the benefit provided by the new approval of Sprycel. We reported that the complete cytogenetic response was superior compared with that seen with the standard therapy Gleevec. However, the figures we provided were for a complete confirmed cytogenetic response, so we responded with a correction to recognize that change.

OK, I must admit, that the person who wrote us about this was from an agency familiar with the trial. But I am dwelling on this point because the details of response are very important—and in a broader sense, the benefits that patients derive from treatments must be communicated clearly, not only for FDA approval, but also so that doctors and their patients can make real-life decisions. 

In the case of CML, there is a reason cytogenetic responses are important—this means disappearance of the chromosomal abnormality that defines CML. However, it also correlates with survival and time to progression, at which point, changes in quality of life can occur. Also, when a response is seen, the rules state that it must be confirmed—this means that it is maintained for a month or more. These stringent guidelines are needed so that we can compare results of different trials and be assured that what is reported as a response is something really meaningful to the patient.

The future of cancer clinical trials is very much in the air as both the pharmaceutical industry and government are pulling back on investments in clinical research. In part, this is due to the economic downturn, but it is also a result of our growing understanding that treatment needs to be individualized to the genetic uniqueness of tumors, and large-scale trials ignore these differences. Now that we have better tools to analyze proteins and genes in tumors and the genetic makeup of individuals, the expectation is that drug development will be much more focused. New biomarkers and so-called “surrogate markers” will eventually replace responses that used to be in the form of measurements of shrinkage (or growth) of tumors on imaging scans. We will be able to perform trials with smaller numbers of patients and in less time. Of course, this is all in the ideal world where the revolution of “new adaptive trial designs” and “full gene sequencing” takes hold, but a lot of homework has to be done before this is a reality. 

The future of cancer clinical trials is very much in the air as both the pharmaceutical industry and government are pulling back on investments in clinical research.

That is where we are at this defining moment—we are retooling clinical trials but are not sure that this will all work quite yet. We have forced the baton to the next runner and hope the wind is at his back. You can be sure CURE will be there with you every step of the way, reporting on this new paradigm of trial methodology that will impact you and the next generation. 

While our CURE team is modest in its artistry and communication skills, I will not be shy in proudly announcing CURE’s accolades at the FOLIO magazine award event in January. CURE won top honors for best full issue in the health/fitness consumer magazine category and for best health/fitness consumer magazine website for curetoday.com. The artwork on the Winter 2009 cover was bestowed a bronze for best consumer magazine cover. 

This is a pinnacle in the competitive field, and I cannot think of a better team to deliver to you the stories, news, perspectives and pictures that convey the changing world of our field. You will hear from us on what progress is being made in the revisionist theme of clinical trials and the nature of the benefits that really matter to you.

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