Backgrounder

Learn about NCI's Clinical Trials Cooperative Group Program and NCI’s efforts to transform the clinical trials enterprise.

FAQs

The most frequently asked questions and answers to how changes in the Cooperative Group system may affect researchers.

1. What is the IOM report?
2. What is the NCI Clinical Trials Cooperative Group Program?
3. Why does the Cooperative Group Program need reinvigorating?
4. Why did the IOM committee issue the report?
5. Who was on the IOM committee?
6. What was the IOM tasked with doing?
7. What did the IOM recommend?
8. Does NCI accept the IOM recommendations?
9. What are some steps NCI is taking to address the IOM recommendations?
10. What are the advantages of consolidating nine adult Cooperative Groups to four or fewer groups?
11. How will the consolidation affect patients and researchers?
12. Do the Cooperative Groups have input into NCI's decisions on this issue?
13. What long-term results are expected from the recommendations?
14. What are the next steps?

> View the 12 IOM recommendations to improve NCI’s Cooperative Group Program, which are based on four broad goals

1. What is the IOM report?

   On April 15, 2010, a special Institute of Medicine (IOM) committee issued a report (A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program) that recommended substantial restructuring and increased funding of NCI's Clinical Trials Cooperative Group Program.
   

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2. What is the NCI Clinical Trials Cooperative Group Program?

   Founded over 50 years ago, the NCI Clinical Trials Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators and enrolls more than 25,000 patients in clinical trials each year. The program is noted for its involvement of physicians and patients from diverse communities who help to ensure that the results of clinical trials are meaningful to a broad segment of the U.S. population. The clinical trials conducted by the Cooperative Groups also provide a valuable mechanism for the training of clinical investigators. A list of the 10 U.S.-based NCI Clinical Trials Cooperative Groups can be found at http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group

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3. Why does the Cooperative Group Program need reinvigorating?

   Numerous challenges threaten the program's ability to conduct the timely, large-scale, innovative clinical trials needed to improve patient care. According to the IOM report, many iterative layers of oversight have made the clinical trials system complex, inefficient, and cumbersome. The average time required to design, approve, and activate a trial is over 2 years, and a substantial proportion of the trials undertaken are not completed. Furthermore, since 2002, funding for the Cooperative Group Program has decreased by 20 percent. However, new knowledge of the molecular changes underpinning cancer and the use of predictive biomarkers in cancer therapy not only increase the potential impact of trials but also add to their complexity and cost.

   The NCI Cancer Bulletin reported (April 20, 2010):

   • In an independent survey of NCI cooperative group members, conducted by the American Society of Clinical Oncology (ASCO) and published in the May 2010 issue of the Journal of Oncology Practice, 33 percent of respondents were planning to limit their participation in NCI-funded cooperative trials and another 9 percent were considering limiting participation.
   • A majority (75 percent) of these cooperative group respondents cited inadequate NCI reimbursement as the reason for limiting involvement in such studies. NCI's per-patient case reimbursement of $2,000 for cooperative group phase 3 studies has not changed in 10 years and falls short of the estimated $5,000 to $6,000 typically spent per patient enrolled, the ASCO authors wrote.

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4. Why did the IOM committee issue the report?

   Former NCI Director Dr. John E. Niederhuber asked the IOM to conduct a consensus study to lend an outside perspective to NCI's ongoing efforts to improve the clinical trials system. NCI has been working steadily to implement recommendations made by NCI's Clinical Trials Working Group in its 2005 report, Report of the Clinical Trials Working Group of the National Cancer Advisory Board: Restructuring the National Cancer Clinical Trials Enterprise. NCI is also implementing recommendations made in a March 2010 report by NCI's Operational Efficiency Working Group (OEWG).

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5. Who was on the IOM committee?

   The IOM appointed a 17-member committee with a broad range of expertise and experience. The committee was chaired by Dr. John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center. View a list of the IOM committee members.

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6. What was the IOM tasked with doing?

   The IOM committee was asked to review the organization and operation of the NCI Clinical Trials Cooperative Group Program and to recommend ways to improve the quality of cancer clinical trials conducted by the Cooperative Groups. Specifically, the committee was tasked with developing recommendations for:

   1. Improving the design, review, and operation of clinical trials
   2. Reducing time spent moving from initial concept to final approval
   3. Prioritizing trials and trial sites based on scientific merit and past performance
   4. Increasing participation of clinicians and patients
   5. Making better use of technologies such as imaging and biomarkers
   6. Defining standards for minimal data requirements for therapy safety and efficacy
   7. Reducing costs and ensuring adequate funds for high quality trials
   8. Promoting greater collaboration among various stakeholders

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7. What did the IOM recommend?

   The IOM committee endorsed several OEWG recommendations for improving the NCI Cooperative Group program and cancer clinical trials in general. The IOM committee issued 12 recommendations to help achieve four broad goals:

   Goal 1: Improve the efficiency and reduce average time for the design and launch of innovative clinical trials by consolidating functions and committees of the Cooperative Groups; streamlining oversight processes; and facilitating collaboration.
   
   Goal 2: Incorporate innovation in science and trial design, for example, by supporting use of biorepositories.
   
   Goal 3: Adequately support those clinical trials that have the greatest possibility of improving survival and the quality of life for cancer patients, and increase the rate of clinical trial completion and publication.
   
   Goal 4: Incentivize the participation of patients and physicians in clinical trials by providing adequate funds to cover the costs of research and by reimbursing the costs of standard patient care during the trial.
   A table with four goals and 12 recommendations is at the end of this document.

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8. Does NCI accept the IOM recommendations?

   The NCI agrees that all stakeholders in a public national clinical trials system share the goals presented in the IOM report. NCI has reviewed the report and is making its own recommendations based on what has already been or is currently being implemented and on its analysis of other critical changes needed to improve the clinical trials system given available resources.

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9. What are some steps NCI is taking to address the IOM recommendations?

   NCI recommends integration of the nine U.S.-based adult Cooperative Groups into a total of up to four groups with multi-modality trial capacity in a broad range of diseases and a commitment to a closely networked national clinical trials system. The single pediatric Cooperative Group, which was created by merging four pediatric clinical trials groups, is expected to remain in its current form.

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10. What are the advantages of consolidating nine adult Cooperative Groups to four or fewer groups?

    Consolidating nine adult cooperative groups to four will reduce redundancy and improve the effectiveness and efficiency of trials. Further, consolidation will result in simplified and better harmonized operations centers, data management centers, and tumor banks. The presence of fewer group disease committees should also foster a more collaborative approach to selecting the most important trials to perform.

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11. How will the consolidation affect patients and researchers?

    NCI remains committed to completing all currently active Cooperative Group trials. Once the consolidation is completed, we anticipate that this improved nationwide system of efficient clinical trials will provide the most rapid and effective transfer of new treatments and cancer control discoveries to patients.

    Consolidation of the adult groups is expected to permit competition for the best trial ideas yet encourage collaboration among researchers. In anticipation of potential investigator concerns about consolidation, NCI has identified several strategies that may ease the transition to fewer groups:

    • Permit multiple principal investigators on a single trial, as is allowed by NIH grants
    • Incentivize the transition with additional resources
    • Allow ongoing trials to continue with a distributed data management and operations system until they are completed
    • Combine (rather than disband) the various groups’ overlapping disease committees to include all current participants

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12. Do the Cooperative Groups have input into NCI's decisions on this issue?

    A change of this magnitude in the Cooperative Groups Program will require dialogue and planning with multiple stakeholders, including Cooperative Group board members, physicians involved in the Groups, the broader scientific community, and scientific societies, industry, patients, and patient advocates. Stakeholders will be given the opportunity to comment on the proposed consolidation.

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13. What long-term results are expected from the recommendations?

    NCI expects that with adequate funds and support, a more effective and efficient clinical trials system will speed the pace of advances in cancer patient care.

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14. What are the next steps?

    NCI is working with the Cooperative Groups and critical stakeholders, including current Cooperative Group principal investigators, professional groups, and patient advocates, to develop consensus on the recommendations. Opportunities for presentations will be sought at Group meetings and at professional society meetings.

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