Just a few weeks ago, we hosted some very interesting and interactive sessions at the SACRA Clinical Trial Conference.
As expected, site budgets and issues regarding payment had come up on a few occasions. This is an issue that repeatedly needs addressing, and given the increasing complexity of clinical trial protocols, it is becoming more critical as the months tick by.
I promised one of my colleagues that I will post the budget items that I review at my site. The amounts have been left out deliberately, as there is some law against what appears to be collusive practice. If you choose the items in my list, you should allocate your own amounts.
Demographics and medical history
Height / Weight / BMI
Rapid antigen test
Pregnancy test (urine)
Spirometry (pre and post)
Laboratory tests (phlebotomy)
Laboratory sample shipping and handling
Laboratory result assessment
Virologic test (swabs)
Adverse event assessment
IP accountability and temp monitoring
Diet or other counselling
HIV pre-test and post-test counselling
Nitric oxide measurement
IV Line insertion
IV drug preparation and infusion monitoring
Study coordinator fee
Study coordinator fee (short)
Physician fee (short)
Subject allowance (normal)
Subject allowance (extended)
Site setup fee
The above list obviously looks at specific line items that should be outlined in a CTA.
There are other issues to consider as well. These include:
Payment terms – I find no justification for a quarterly payment cycle, as we usually have a few days to enter data in EDC systems. Being a data driven industry, payment terms should be a minimum of a monthly payment cycle.
Start-up fees – my research has shown that approximately 60 hours are spent in start-up activities. These should be acknowledged by sponsors, and reimbursed to sites.
Reconsenting fees – Again, based on time involved for the many possible amendments in a study
Screen failure caps – this is a significant problem in some studies. I have declined studies if the sponsor had not considered relaxing this part of the CTA
Archiving fees – this should be based on actual costs – it is not possible to predict at the start of the study how many boxes will be needed
These are the basics that I look for in my CTA review. I am certain that each site has there own processes of review and I will be keen to learn from you.
This will be my last blog post for 2018. Wishing you all a safe festive season, and the best for 2019.
Dr Essack Mitha