The ASCO-IOM Implementation Workshop

The ASCO-IOM Implementation Workshop

George W. Sledge, MD, FASCO

Mar 22, 2011

As an organization of clinical oncologists, ASCO has a special and lasting interest in the fate of the nation's Cooperative Oncology Groups. These groups have, over the years, been the engines of progress in cancer care. But like all engines, the moving parts wear out, and the grit of regulatory burden has gradually ground down the gears. Multiple federal panels have recommended overhaul of the cooperative group machinery, recommendations that have been largely ignored. At the same time, the finances of clinical trial participation have gradually worsened, to the point that the labor of love these trials represent has become unacceptably burdensome to many.

The most recent federal panel studying the groups led to the Institute of Medicine's April 2010 report entitled A National Cancer Clinical Trials System for the 21st Century. After the report came out, there was concern in the cancer community that, once again, we were capable of identifying the system's pathology but incapable of fixing it. ASCO shared this concern and has tried its best to serve as a facilitator and to keep the trial system's concerns on the front burner. As part of this process we, along with the IOM's National Cancer Quality Forum, hosted an implementation workshop, March 21, 2011 at the National Academy of Sciences' Keck Center in Washington.

The workshop brought together an amazing array of stakeholders. The clinical trial system's problems, as everyone is fond of reminding you given half a chance, are complex because the system is complex. The clinical trials system involves a matrix of federal regulatory agencies (an alphabet soup that includes the NCI, the FDA, Medicare, and OHRP [Office for Human Research Protections]), all of whom have different responsibilities and none of whom has overall authority. In addition, the cooperative groups themselves are not all of one mind as to the appropriate fixes, the payers (public and private) are concerned about health care costs more than clinical trials (though many are supportive), and consumer groups, cancer centers, and individual investigators all bring separate needs and agendas to the mix.

This may seem a prescription for inaction, but the workshop was able to bring all of these parties together—something of a miracle—and get them to address the issues in an open public forum. This is an important first step. Suanna Bruinooge of ASCO’s Government Relations group, along with Sharyl Nass of the IOM, deserve credit for putting this important meeting together.

Announced Partnerships
One thing I learned is that the Cooperative Groups have already gone through more substantive changes in the past year than in the past decade. These changes may not be familiar to all of you, but include significant new collaborative partnerships by many of the groups. The IOM recommended, and the NCI is endorsing, a reduction in the number of groups. Announced partnerships (one hesitates to call them mergers yet) include ECOG with ACRIN, ACOSOG with CALGB and NCCTG, and the NSABP with RTOG. What these new entities will look like, or what they will be called, is anyone's guess at this point, but active discussions are underway between the groups and with the NCI.

You cannot merge your way to greatness or efficiency, as even a cursory look at the business world suggests. Speaker after speaker at the workshop returned to this basic point. You must also change the way you do business. We need, as Rich Schilsky (who led the workshop on ASCO's side along with John Mendelsohn for the IOM: kudos to both) said, functional as well as anatomic reorganization.

Take the group's informatics needs. Each of the cooperative groups developed separate informatics systems over the decades, and by and large they do not play well with each other. Even within a group one is faced with what ECOG's Bob Gray called "legacy studies in legacy systems"; a trial created in an era of different RECIST criteria, different toxicity criteria, and different follow-up than we would use today, attached to a tissue bank using a separate storage and collection process and requiring a decade or more of data collection is a problem when one tries to merge data systems. We need common data systems and standards across groups, or having five mega-groups represents no major functional advantage over ten smaller groups.

While attention has necessarily focused on the NCI, the solutions required to fix the system require more than the NCI. What can we do about our totally dysfunctional IRB [Institutional Review Board] system, where added layers of bureaucratic complexity have slowed down the clinical trials process without significantly adding to patient safety? One possible solution--endorsed by OHRP (the agency responsible for the IRB system) and (we heard today) moving towards reality--would involve a reduction in the number of IRBs required to sign off on a protocol. This simple fix should have happened years ago: if the NCI, the FDA, a cooperative group, and a national IRB have already vetted a trial, what does local sign-off add other than expense and time wasted? Similarly, the process of informed consents clearly needs fixing, though what I heard from the OHRP representative at the workshop is that this form of manifest dysfunctionality is further away from a fix than we might like: there are still those who seem to believe that a nine-page informed consent is three times as good as a three-pager, evidence to the contrary notwithstanding.

Efficiency of Clinical Trials System Improving
One delightful bit of news, delivered by Jim Doroshow of the NCI (and ASCO member) is that the efficiency of the clinical trials system is already improving, as the application of real metrics to the process of opening clinical trials has resulted in a major speed-up in their movement through the system. Both the NCI and the Cooperative Groups deserve our applause for this improvement, which followed from the publication of the Dilts study in JCO outlining the system's many inefficiencies.

I have felt for a long time that the clinical trials system's wounds were largely self-inflicted. Like most human-caused problems, they should have human solutions, if we can work together. But the work is hard, and it will take a long time. It requires both the good will and support of the many stakeholders involved. And not all of the stakeholders appreciate the cooperative groups. There are those who argue that the groups are inefficient dinosaurs, and out of touch with modern science, and that the resources devoted to them might be better spent elsewhere.

I find this belief disappointing, and out of touch with the changes occurring in the groups. I have already discussed the issue of efficiency: the process is improving, and should improve more. But in addition, the groups are now becoming a home for great translational science, in cooperation with cancer center researchers: as Jan Buckner of the NCCTG pointed out at the workshop, over 60 RO1s [NIH Research Project Grants], multiple PO1s [NIH Program Project Grants], and a large number of SPOREs have fed off of group trials in recent years, and more would likely do so if the cancer centers and SPOREs [Specialized Programs of Research Excellence] were incentivized to support group science rather than segregated into institutional silos by outdated review criteria. Such useful changes in review criteria, we heard today from Jim Doroshow, are in the offing.

I feel, as many do, that national clinical trials are hard and require the special expertise that only a cooperative oncology group network can provide. We need a federally supported clinical trials network; no reasonable alternative exists. But we need something more, a broader vision of our future. We need to reject the belief that cancer research is a zero-sum game. We need, all of us, to see our way to a place where the many pieces in this complex puzzle—the cooperative groups, the NCI and other federal agencies, the insurers, patients and consumer groups, individual researchers in lab and clinic, in academia and community practice—are seen as valuable partners working towards a common goal. This is why ASCO has supported the recommendations of the IOM so fervently, and why we continue to support a doubling in dollars for our national federally funded clinical trials system. We need to think smarter and act better about the system that has given hope to so many.


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