Posted by Michael Jay on Thu, Jul 22, 2010
A common concern among research sites is that of capturing all of their startup costs for a trial. Estimates of these costs can range from $5,000 - $15,000 and most sites with which we associate are not reporting that sponsors are paying these sums. This is not surprising as half of all sites will enroll zero or one subject and also keep in mind that it costs sponsors $15,000 - $20,000 (according to them) to start each of those sites up. Therefore, a site should plan to recover these costs (after a well-presented argument for payment of full startup is rejected) by building them into the per-subject budget and then meeting their enrollment goal. Front-loading these costs into the first visits of the trial is preferential. If a site cannot do this, and the site relies on profit to function and survive, it should not take the trial unless there is a strategic reason to do so.
I have presented below a fairly complete list of a typical site's startup items. This list is the composite result of meeting site managers and owners at conferences, our Hidden Costs presentations, and the Site Solutions Summit. Some sites may have their own items not on this list. I have not included items done prior to site selection as I consider these items to be part of the overhead. Readers may download a complete list of all startup and other line items in Excel format here. I will go through the list below and determine, based on my experience, what makes up each item and the coordinator time associated with each task. Assign an hourly rate to each item to determine your startup budget. Your hourly rate should include benefits, overhead, and profit. Determining your coordinator's billable rate will the topic of a future article.
|
Budget & contract review, negotiation, preparation
- 3 hours coordinator or dedicated contract reviewer time
- contract may be split into pricing and language departments, and some departments may charge a fixed rate
- Attorney's fees, if applicable
|
|
Investigator meeting
- 16 hours coordinator time
- Some sites are charged by the Investigator for this time
- This is a cost taken on by sites and is rarely directly compensated
|
|
IRB - preparation & initial submission
- 2 hours coordinator time outpatient, up to 40 hours for inpatient sites
- this item covers a site's time for preparing the initial submission paperwork to the IRB, responding to correspondence, ICF edits, etc.
- this is not the IRB's charge for approval of Investigator
Creation of recruitment materials
- 3 hours coordinator time
- Sites must prepare the ad materials that they will send out to potential subjects in their database and distribute around the medical campus. Sites (and every ad agency) know that people respond better to a cohesive, repetitive, identifiable campaign rather than one that uses a different message and artwork each time. Therefore, the site will do better if they create the ad material rather than using what is provided by the sponsor.
- save the sponsor money by turning this in with your initial submission
|
|
Lab set up
- 1 hour coordinator time
- If the site has a dedicated lab, that lab may charge for the time spent in review of protocol and setup time
|
| |
|
Pharmacy Startup
- 2 hours coordinator time for these activities
- If site has a pharmacy, the pharmacist may charge a fee to review the protocol and prepare for the trial.
|
|
Pre-screening for eligible volunteers
- 4 hours coordinator time
- database review, chart screening
|
|
Site initiation visit
- 6 hours coordinator time
- A site will staff this meeting with at least one coordinator for about 6 hours and the Investigator for 1 hour
- additional staff may be present: blinded coordinator, data entry
|
|
Source document preparation
- 3 hours to create, print, organize for a trial with 6 visits enrolling 10 subjects
|
|
Study-specific staff education
- 2 hours to train the facility staff on subject identification and how to contribute to the enrollment, initially
|
|
Training, research staff
- 2 hours training on EDC system, other study-specific software / hardware
The number of hours coordinators spend starting a trial can begin in the low 40's, so for a coordinator that starts 5 trials per year that could mean 5 weeks of uncompensated work if not properly captured in the trial budget.
And that's just startup.
<back
|
| |