NCI announces plans to reinvigorate clinical trials

NCI announces plans to reinvigorate clinical trials
Consolidation of cooperative group program is designed to bring enhanced efficiencies to oncological sciences

From the NIH release

The National Cancer Institute (NCI) has announced major changes to be made in the long-established Clinical Trials Cooperative Group Program that conducts many of the nationwide trials of new cancer therapies. In a major transformation, NCI intends 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. These changes are designed to provide greater benefits for cancer patients and more information for researchers. These moves come in response to an NCI-requested April 2010 report from the Institute of Medicine (IOM)**, which called for a series of changes to the cooperative groups program, including restructuring….

….The April IOM report noted that the current trials system is inefficient, cumbersome, underfunded, and overly complex. The report recommended consolidating existing adult cooperative groups into a smaller number of groups that could function in a more closely integrated manner….

…For the past several decades, clinical cancer trials have used one or a combination of drugs or other treatment modalities, such as surgery or radiation, in comparison to the prevailing standard of care to see if the new treatment was superior. Recently, some trials have begun to depend on the genetic profiling of tumors. For example, one ongoing NCI-sponsored breast cancer study, called TAILORx, is examining whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to more appropriate and effective treatments.

These types of studies necessitate the screening of large numbers of patients in order to find subsets of patients with tumors that demonstrate changes in specific genetic pathways. These trials therefore require acquisition and distribution of many tumor specimens, DNA sequencing, and the matching of genetic information with treatment options. The increased complexity of these trials provides a rationale for modernization and simplification of the current cooperative group structure…..

..On Jan. 1, 2011, NCI will impose new deadlines, formulated by its Operational Efficiency Working Group, which will reduce by half the time to initiate new clinical studies and will terminate studies not begun within two years of concept approval….

**The IOM Web site has over 50 results with the search phrase clinical trials, including the most viewed Biomedical/Health Research report (as of Dec 27, 2010) – Transforming Clinical Research in the US: Workshop Summary

General Information about Clinical Trials (select Web sites)

• Clinical Trials (MedlinePlus) has overviews, related issues (as informed consent and ethics), directories, and more
• Understanding Clinical Trials (ClinicalTrials.gov) answers many basic questions relating to participation, safety, ethics, and types of clinical trials
• ClinicalTrials.gov is a registry and finding aid for clinical trials. It currently has 100,613 trials with locations in 174 countries. One can search by topic (as a particular drug or disease) or use the advanced search to use limiters as location, conditions, age groups, and sponsors. Results give contact information for individual clinical trials.The page How can I find the results of a clinical trial? provides places where they might be found, including the ClinicalTrials.gov Web site.