SLIDES & TRANSCRIPTS
Wednesday, February 2, 2000

Report from Working Group C
Martin Tallman, MD

DR. TALLMAN: We discussed a number of Phase II and Phase III trials that the group felt should be conducted. However, we ended up actually focusing and spending a lot of time talking about more process and organization and strategies to improve the process to conduct clinical trials. So, I am going to focus my comments on that.

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We actually spent a considerable time talking about the various impediments to the conduct of clinical trials, and they are listed here. Let me just outline them and make a couple of brief comments.

The point was made that sometimes there is a lack of trials because there just aren't exciting trials to conduct. It is hard to generate enthusiasm on behalf of funding agencies, members of the cooperative group, patients, physicians and the community.

We also made the point that there is significant competition for patients. There may be two cooperative groups, or an independent institutional study and a cooperative group study, that are vying for the same patient population. There is also competition for funds to conduct those studies and correlative laboratory studies.

The point was made that the decision as to what institutions get to collaborate to conduct a certain trial is somewhat arbitrary and perhaps somewhat political. We spent a lot of time talking about the obvious problem of the long time it takes to bring a trial from the initial concept submission to the actual activation of the trial. There are many steps in this process, and we talked about some ways to shorten that process.

The point was made by several people that there may be inadequate academic reward for clinical investigators, and no one is really rewarded for spending all the time it takes to put their patients on other people's trials. There was a feeling that their own institution, for example, inadequately rewards them for that kind of collaboration. We also talked about the lack of academic reward and lack of time provided by an institution for someone even to be the principal investigator on a trial. There was a feeling that our institution's don't provide adequate protected time and funding.

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We talked about the current mechanism of the National Cancer Institute's funding of cooperative groups and the way this inherently contributes to competition, although I think in leukemia the cooperative groups have never worked more closely.

We, also, spent time talking about delays in processing commercial contracts for drugs and the delays that the legal departments at various pharmaceutical companies take to complete and execute a contract.

We talked about the potential problems of higher reimbursement from pharmaceutical companies which encourages investigators in the community to participate in those trials as opposed to NCI-sponsored or cooperative group trials.

We spent considerable time talking about the simple lack of accrual to clinical trials as an impediment to their completion -- not so much a lack of patients but a lack of accrual to those trials.

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We spent time talking about the limitations imposed by new data monitoring committees such that principal investigators are now actually not allowed to attend the data monitoring committee meetings. Thus, they have limited access to the data their trial is generating. We did not support this practice.

We talked about the impediments of statisticians. Although statisticians are obviously critical to the conduct of these trials, there are certain impositions they pose and certain limitations.

We talked about ways to possibly improve data collection in terms of retrieval and collection of clinical and laboratory data in a very timely way.

We all felt that we have failed to take full advantage of the Internet. We talked about patient heterogeneity as an impediment to the conduct of clinical trials.

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We, also, this morning, talked further about the issue of companion correlative scientific studies. Everyone feels that in order to answer a clinical trial question, we must be able to collect a variety of laboratory specimens and should these be mandatory. However, several people were appropriately quick to point that there are institutional review boards that may feel that it is coercive to tell a patient that you need to collect the laboratory samples, and if for some reason your bone marrow isn't aspirable or you don't have adequate cells for example, you cannot participate in the clinical trial. We talked about reduced IRB delays, touched upon it a little earlier this morning, and recommend some kind of a centralized IRB, a more centralized process. We talked about reducing the burden of relevant data that needs to be collected. We talked about a more complete NCI registry.

The point was made that there are clinical investigators who are prepared to conduct certain trials. They may not be aware that there may be competitive or similar trials although PDQ lists many of those trials and there are other mechanisms by which those trials are collated in a list. We felt that perhaps a more complete perhaps NCI sponsored registry would be useful.

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Again, we talked about taking more full advantage of the Internet. We talked about taking more advantage of patient interest groups.

We spent time obviously talking about the technology as a way to strengthen some of these problems.

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Although there has been a lot of global collaborations between the United States groups and Europe and these actually have been very, very successful, the point was made that this will probably only occur more often, and ways in which we can facilitate this would be useful.

We talked a little bit about conduct of the kinds of trials that were mentioned earlier today where one may have not the most exciting trial, but a trial that may have a major impact on the quality of life of patients or on the economics of the health care delivery and long-term follow-up.

So these were the limitations and opportunities our group discussed.

DR. LARSON: Questions or comments?

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