Blog Entry: September 26, 2011

Prior to starting my fellowship at ENACCT, the failure to accrue and retain patients in cancer studies was an issue that was not new to me.  When dealing with studies focused on less prevalent cancer types , the identification of patients was inherently challenging.  Clinical studies specific for the treatment of refractory CLL or AML/sMDS patients were very difficult for community sites to meet enrollment expectations.  Physicians in the community setting may see less than 5 of these types of patients annually, and often times the inclusion/exclusion criteria are very specific thus restricting the potential patient pool even further.  The expectation for accrual was low for these trials, but it was still a difficult process for the sites to accrue.  It is eye opening to find recent research displaying accrual rates to be as low as less than 1%.  I did not expect the rate to be that low nor did I expect this rate of under enrollment shown across the more common solid tumor types.  It is especially surprising since the national cancer treatment guidelines cite clinical trials as an important part of patients’ treatment plan making clinical trials part of quality care.

A recently published analysis by Al-Refaie et al in the September issue of the Annals of Surgery, provided further evidence of the under enrollment of cancer patients into cancer treatment studies. Al-Refaie et al, reviewed the California Cancer registry from 2001-2008, which included over 240,000 patients to determine patterns and predictors of enrollment of patients with solid tumors who received surgery as their primary treatment.  The results of the analysis demonstrated less than 1% (0.64%) of the patients were enrolled in cancer studies. Also noted in this analysis was an under-enrollment based on age, cancer stage, race, and patient status.  Of course there are some limitations with these types of analyses, but the general findings show a much lower accrual rate than previous published rates of ~3% in addition to a clear underrepresentation of the minority groups. 

These rather poor findings raise numerous questions around potential issues with the accrual of patients into cancer clinical trials such as:

• What are the barriers for patients to gain access to cancer clinical studies?  Is there a lack of awareness of the clinical studies?  Do the patients have negative perceptions about clinical trials and if so, what needs to be done?
• What can be done to help address under-enrollment among the minority population, as well as reduce the age disparities?  How can healthcare providers help improve enrollment opportunities and reach out to these patients? 
• Are there adequate processes in place so that each patient being treated for cancer can be given the opportunity to enter a study?  Are the physicians involved in the care of the patients, other than the oncologists (surgeons or primary care physicians) informed of what studies are going on and can they do a better job of informing the patients accordingly?

Based on the questions that arise, it is clear the importance of the activities and services I will be involved in with ENACCT. It places further strength around the importance of the National Cancer Clinical Trials Pilot Breakthrough Collaborative to develop best practices to increase patient participation in cancer treatment trials.  In addition, the need to educate community based organization that work with minority groups or underserved populations to enhance cancer clinical trial awareness, and the importance of building a network of healthcare providers as advocates for cancer clinical trials.