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Proposed Restructuring of NCI Clinical Trials System Calls for Increased Role of Community Oncologists: An Interview With James H. Doroshow, MD

James H. Doroshow, MD

In June 2005, after a year of development, the National Cancer Institute's (NCI's) National Cancer Advisory Board accepted a plan to restructure the NCI clinical trials system. The plan was developed by the Clinical Trials Working Group (CTWG) under the leadership of James H. Doroshow, MD, director of NCI's Division of Cancer Treatment and Diagnostics. The broad-based group includes representatives from industry; professional associations, including ASCO; and institutions involved in clinical research.

NCI's director, Andrew von Eschenbach, MD, asked Doroshow to review how clinical trials are supported across the institute, "with the notion that we need to understand in more depth how our clinical research activities were coordinated, how efficient they were, and, given that we're facing a time of flat budget, how we could use resources most advantageously," he explained.

Those recommendations are aimed to step up the speed and effectiveness of clinical trials by better coordinating the efforts of the clinical trials community, improving the quality of clinical research, and increasing efficiency of the process.

Those changes won't leave community oncologists behind, reassured Doroshow. One of the recommendations is, in fact, to increase community oncologist involvement in clinical trial design and prioritization to improve patient accrual and better address practical and quality-of-life concerns.

"This document," he said of the recommendations, "speaks to the importance and involvement of community oncologists in the clinical trials process—at least the government-sponsored clinical trials process—in a way that's never before been emphasized.... We will be calling upon many community oncologists to give of their time to participate in the process of developing national phase III trials in a way and to an extent that may surprise them. I'm very hopeful that they will be able to give enough of their time to be able to participate at the level that we are going to be asking them to.

One of the ways that recommendations will be implemented, he told the Journal of Oncology Practice, is through a network of scientific steering committees, which will be set up to work with the cooperative groups, specialized programs of research excellence (SPORE), and cancer centers on trial design. "Community oncologist and patient advocate participation will be a requirement of the development of these steering committees," Doroshow said.

We will be calling upon many community oncologists to give of their time to participate in the process of developing national phase III trials in a way and to an extent that may surprise them.

—James H. Doroshow, MD

He noted that some community oncologists may have had concerns about their ability to participate in clinical trials because of a temporary hiatus in the acceptance of applications for new Community Clinical Oncology Program (CCOP) grants. But research through CCOPs as well as through the Cancer Trials Support Unit (CTSU), which gives practices that can accrue five patients or more each year access to national phase III trials, will continue and will be essential to implementing the CTWG recommendations, he said.

Some of the recommendations aimed at improving scientific quality, such as credentialing and speeding patient accrual, have some community oncologists concerned about their ability to commit resources to the training they may need to do for their staffs and their ability to accrue more patients. But, Doroshow pointed out, accruing patients faster is essential to increasing the speed with which trials are completed and getting new therapies into the community. The efforts to better inform physicians and patients about the existence of trials should help increase accrual, and he emphasized that implementing recommended efficiency measures will help offset the investments oncologists will have to make. "The more standardized the infrastructure, the easier it will be for everyone," he said.

For example, he noted that a foundation of the recommendation to develop a new information technology infrastructure for clinical trials will be standardized case report forms. That, he said, is "a major effort that we hope to conduct, in consultation with FDA [U.S. Food and Drug Administration] and industry as well as the clinical trials community. Developing standard, electronic case report forms will really improve the efficiency with which the trials can be conducted. That will eliminate much of the time and training it takes to report data differently for every sponsor."

Moreover, the new database for clinical trials information should help make clinical trials data widely available and adaptable for community oncologists. Right now, he pointed out, "there is no comprehensive database that contains all trials that the NCI supports." The database, he explained, would not just list all NCI-funded trials but would include regularly updated clinical trials data, such as accrual, effectiveness, and side effects. It will build on the already existing cancer Biomedical Informatics Grid (CaBIG), a program launched last year to allow cancer researchers to share tools, standards, data, applications, and technologies.

In addition, adopting a central institutional review board at NCI, another of the recommendations aimed at increasing efficiency, should make the review process faster and reduce the time and resources needed to open trials at individual sites.

Soon, oncologists will begin to see how many of these recommendations will be implemented. The entire plan is projected to be complete in 2009 or 2010, with the majority of initiatives implemented by 2008. In 2006, implementation will begin of many of the recommendations that will facilitate community oncologists' involvement, including efforts to increase community oncologist involvement in clinical trial design, establishing the network of scientific steering committees, and establishing the information technology infrastructure, which includes the clinical trials database and standard reporting forms.

For more information about the recommendations and their implementation, visit http://integratedtrials.nci.nih.gov/.

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