E-Newsletter - October 2015

Upcoming pilot project from the Alliance oncology nursing committee Team

Have you been asked to activate a trial at your site, only to find out, that it uses an infusion pump that your institution doesn’t use, or there is a PK sample required on a day that your site is not open?

Trials are becoming more complex, with increased requirements for eligibility, treatment, and translational research. Additionally resources are increasingly limited and centers are trying to find ways to optimize and open the most appropriate trials for their site. We are all under a great deal of pressure to open and accrue to trials in the most efficient manner possible.  In an effort to aid sites with this process, the Alliance Oncology Nursing Committee (A-ONC) is launching a pilot project to help sites determine early on in the activation process the appropriateness and ability of a study to be opened and accrue at a particular institution.

In response to feedback from an Oncology Nurses Open Forum, we have developed a pre-trial assessment checklist (co-led by Ilene Galinsky, APRN, CNP and Sharon Levy, RN, BSN), The checklist is designed to be used as a tool at the time of study pre-activation to assess if a particular trial is feasible to be opened at a particular institution, prior to IRB submission. This checklist will be study specific and thus should allow a site to identify potential issues early on in the activation process and allow problem solving prior to a protocol being activated.

Below is a list of some examples of the types of questions on the assessment form:

  1. Does your site have the ability to run a PK sample after 5 pm?
  2. Does your site have CADD pumps?
  3. Can your site ship out samples on a Friday? Which courier service do you use?
  4. How many patients with this diagnosis do you see per year?
  5. Does this trial compete with other trials in this disease category?
  6. Are there special training requirements, such as PET credentialing?

As part of this pilot project, we will ask participants to complete a small survey to collect data on the usefulness of the tool and provide for means of tool improvement. Stay tuned for additional details. 


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For other articles in the October issue of Alliance E-News, see below.