Guest Expert Diane St. Germain: Success with a screening log
We are delighted to introduce Diane St. Germain, RN, MS, as our latest AccrualNet Guest Expert. Diane is an oncology nursing colleague who has worn many hats--staff nurse, research nurse, palliative care nurse practitioner, and for the last 7 years, Nurse Consultant in the National Cancer Institute's Division of Cancer Prevention where she serves as a Program Director within the Community Clinical Oncology Program. Diane played a key role in the NCI's National Community Cancer Centers Program (NCCCP) as a member of the Advisory Committee and advisor to the Clinical Trials Subcommittee. In celebration of the team's recent publication in the Journal of Oncology Practice, we asked Diane to share some of the experiences with you. Welcome, Diane!
Clinical trial accrual has been an age old problem. Despite efforts to address barriers to clinical trial accrual, the percent of patients placed on clinical trials remains stagnant. Factors contributing to low accrual in addition to these barriers include the lack of a physician champion, lack of staffing and institutional support, increase in regulatory demands, increase in trial complexity and lack of trial availability for certain patient populations just to name a few. While some of the barriers are challenging to overcome, there are successful strategies documented in the literature. Despite this and our understanding of the barriers, why has the percent of patients enrolled on clinical trials not budged for years? What will it take to move the bar? Could it be that the information on hand is not granular enough and the strategies in the literature are not adequately tailored for individual sites?
The National Cancer Institute Community Cancer Centers Program (NCCCP) attempted to create a tailored approach to identify their site specific barriers and so developed the NCCCP Screening and Accrual Log (“The Log”) for selected NCI sponsored clinical trials. The data is available in real time and allows sites the ability to identify patterns in reasons for ineligibility, reasons patients as well as physicians decline participation despite eligibility and provides demographic data of those screened (age, race/ethnicity, gender). The sites quickly recognized the benefits of The Log beyond accrual. It can provide information regarding staffing requirements for clinical trial screening and can assist with managing a site’s trial portfolio. The Log can be used by the principal investigator of a trial to examine the barriers and make changes in eligibility or trial design as appropriate. Lastly, The Log data can be used across sites to share strategies, in particular, sites can benefit from learning about strategies used by high accruing sites.
Though the NCCCP sites initially felt the use of The Log was burdensome, with time they saw the value of it, so much so, all but one site uses The Log for all of their trials versus only the NCI intended select trials. More importantly, the efforts paid off with an increase in accrual seen at many of the sites.
Many community sites use screening logs. Does yours? If so, what value does it bring to your site? What are the challenges? Has the use of a log impacted accrual?