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Commission on Cancer Standard 1.9

Last Updated: Jun 7, 2013

Accepted definitions related to clinical trial accrual

Sandra's Image

This is incredibly basic, so I apologize for that.  I had assumed everyone defined terms as we do and just realized that does not seem to be the case.  Given that the accrual percentages are increasing for accreditation and commendation, I'd like to be certain we're on the right page and not short-changing ourselves.  Here are the questions:

We take "...is accrued to cancer-related clinical trials each year" to mean those patients consented/randomized during that year only.  Do any of you use an accrued-to-date approach for this?  Is that acceptable?

When a patient enrolls in a study, we count that as one even if there is an optional portion of the trial with a separate consent.  Is it acceptable to count it as 2 if 2 consents are signed for one study?  Say the main trial consent and an optional tissue repository consent?

How do you define the peer-reviewed requirement in determining what trials count?  We would assume that if a physician develops some sort of survey study for his patients, even though it goes through IRB for approval and funding isn't needed, it is not considered peer-reviewed since it didn't go to any other committee or agency to be approved by other investigators (as normally would happen if it had to compete for funding).  Does IRB review count as peer-review??

Just looking for guidance on what I thought we already knew, any feedback would be appreciated!  Thanks!

Ellen Richmond's Image

Hi Sandra,

You have asked great questions. I will be interested in hearing how others in the community handle these requirements.  As you know the Commission on Cancer is a program of the American College of Surgeons. Your best bet may be to contact the ACS directly. I noticed that there is a "Contact Us" link on their web site. You have probably already visited their site - they provide a lot of useful information. I understand you wanting to be sure that you are understanding exactly what is meant by each standard so that you can report accrual data accurately. I will look into this further with clinical trial colleagues in the community and at NCI but wanted to get back to you with this preliminary response so that you know we are listening. Stay tuned!

Ellen

Sandra's Image

Thank you!  I'm actually waiting to be approved so I can view their cAnswer forums, something may be in there but I thought maybe there were obvious accepted answers and I just wasn't aware of them.   Most of my background is in non-clinical research admin, I'm really new to this side of things :)

Sandra's Image

I was finally able to access the cAnswer forum and it turns out I was mostly wrong in my previous assumptions.

Patients do only count for the year they were consented, it is not cumulative.

All optional parts of a study, such as the tissue repository, etc count as separate accruals as long as it is still part of the IRB-approved consent, truly optional where the patient can be in the main study but opt to be in the other part or not, and it is specifically related to cancer (so the optional repositories where they ask if the patient wants tissue to be available for research on other diseases or disorders do not count).

IRB review actually is considered peer review - not what I would have guessed.

This is great, it changes our numbers drastically for the better!

 

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