NCI takes first step to re-vamp clinical trials process in US

On December 23, the National Cancer Institute (NCI) issued a media release announcing a first step toward major changes in how big, cooperative clinical trials get managed and funded in the USA. The media release seems to have managed to escape anyone’s notice until today.

The NCI has historically funded at least some of the trials and operations of 11 different “cooperative groups” of physicians who have worked together to develop and carry out cancer trials. These groups are:

  • American College of Radiology Imaging Network (ACRIN)
  • American College of Surgeons Oncology Group (ACOSOG)
  • Cancer and Leukemia Group B (CALGB)
  • Children’s Oncology Group (COG)
  • Eastern Cooperative Oncology Group (ECOG)
  • European Organization for Research and Treatment of Cancer (EORTC)
  • Gynecologic Oncology Group (GOG)
  • National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG)
  • National Surgical Adjuvant Breast and Bowel Project (NSABP)
  • North Central Cancer Treatment Group (NCCTG)
  • Radiation Therapy Oncology Group (RTOG)
  • Southwest Oncology Group (SWOG)

Over the past 20 years, five of these groups (highlighted in bold italic type above) have been at the forefront of some of the major trials that have helped to change the management of localized and more advanced forms of prostate cancer. Three of these major trials that may be familiar to readers are:

  • SWOG 8494, which first demonstrated the potential value of combined androgen deprivation with an LHRH agonist and an antiandrogen in men diagnosed with very late stage prostate cancer
  • EORTG 22863, which demonstrated the potential of combining radiation therapy and hormone therapy to increase the survival of patients diagnosed with locally advanced prostate cancer
  • SWOG 9217 (also known as The Prostate Cancer Prevention Trial) which first tested the potential of finasteride as an agent to prevent prostate cancer

According to the media release from the NCI, the intention is to “consolidate the nine groups that currently conduct trials in adult cancer patients into four state-of-the-art entities that will design and perform improved trials of cancer therapies.”

Only one of the cooperative groups listed above is actually focused exclusively on cancers that are observed in children as opposed to adults (the Children’s Oncology Group or COG). We certainly can see the benefit of not messing with that specific group. This leaves 11 other cooperative groups that deal with adult cancers (not nine, as suggested in the media release), but two of those groups are not based in the USA at all.

Our assumption is that what is actually being suggested is that the nine groups that do not include COG, EORTC, and NCIC-CTG are the ones that will be consolidated into four groups, and that the two non-US groups (ECOG and NCIC-CTG) will still be able to participate in the trials coordinated by these four new groups but will not, in the future, be able to receive direct funding from the NCI.

It will be interesting to see how this plays out. There will undoubtedly be a lot of internal politics within the academic cancer community with respect to the leadership and missions of the four new groups. We would hope that at least two of these groups retain a strong interest in prostate cancer. However, on the whole we see this as a positive first step toward the promised process of improving the development of meaningful clinical trials and the speed with which such trials get approved, funded, and implemented over time.

For those who are interested in more information about the proposed reorganization of the cooperative group trials process, we recommend the following links:

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