have resulted in improved care and outcomes for cancer patients. Mooney explained that the program’s accomplishments over the past 50 years have been a result of the direct involvement of clinical investigators, patients, and their families in designing, conducting, and monitoring clinical trials. The early and ongoing involvement of patient advocacy communities in designing and conducting clinical trials has resulted in some of the most robust improvements in cancer treatment to date.

Because the NCI cooperative groups are not oriented to gaining regulatory approval for a new drug, as is the case in industry, they can take a broader, public focus and examine multiple types of research questions in one trial. This breadth of focus is significant with respect to the amount of useful research data that has been generated by going beyond the traditional primary endpoint of a trial. Mooney explained that the large amount of data collected in response to multiple research questions in NCI-sponsored trials can be extremely helpful in learning more about cancer and how to manage it effectively, but also makes some of the trials less pristine in terms of efficiency.

As the field of oncology has progressed over the last 50 years, the true diversity of the set of cancer diseases has been uncovered. Mooney explained that the new understanding of the molecular classification of cancer diseases has allowed a greater focus on particular treatments and patient populations. Thus, new sets of challenges in cancer clinical research have been created. Screening patients for particular molecular characteristics using tissue samples has introduced a new level of scientific and logistic complexity to clinical trials. Mooney explained that the search for rare patient subsets is one reason why clinical trials have become increasingly global—enough patients cannot be found in the United States.

Streamlining NCI’s Clinical Trials Process

Despite differences in research focus, the NCI system shares with industry and all medical disciplines the growing pressure to reduce research costs in the face of declining budgets. In response to this challenge, the NCI Clinical Trials Working Group was launched in 2004. This group is charged with developing recommendations and an implementation plan to optimize the NCI clinical trials system in five critical areas (Box 6-1).

INDUSTRY-SPONSORED CANCER CLINICAL TRIALS

Many issues and obstacles encountered in the clinical trial process are common across organizations that sponsor the research, whether government or industry. In terms of cost, Canetta noted six major drivers for industry-sponsored clinical trials in cancer:



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