You have a new drug awaiting clinical trial, but your site activation process is stuck in the mud. Every day that passes is another delay in finding the patients you need. Getting the data you want. Generating the revenue you require. So why is site activation such a slow slog?
#1. Training Tribulations
To fulfill trial protocols, sites have to train and re-certify personnel and equipment for each and every study. Lab training, rater training, electronic data capture (EDC) training and more all take time – sometimes up to 30 hours per person.
You might be running ten clinical trials at the same site with the same drug to study mild deviations. It doesn't matter. The training and certification have to be completed for each study. There is no industry-accepted procedure to "check the box" after completing the necessary training and certification for one trial to satisfy the needs of other trials, or to use the training and certification done for one sponsor to meet the requirements of another sponsor … even if the requirements are identical.
The result is the operational equivalent of a mud-filled swamp. Personnel are often frustrated, having to be trained and retrained on procedures with which they are perfectly familiar. It is not uncommon for personnel to drag their feet, resisting the training and recertification process and further delaying study startup.
#2. Contract Conundrums
When communications about budgeting and contracting get bogged down, site activation slows to a standstill. This may occur because of inexperienced negotiators – such as when a receptionist is asked to handle a financial contract. Poor follow up is another culprit, as matters sit for weeks without being addressed. Then there is the greatest time waster of all: the fact that every study is typically entered into as if it is the first study the CRO or site has ever done with the sponsor … even if it is actually the fiftieth or hundredth. Recreating the wheel takes (unnecessary) time.
#3. Supplier Slip-ups
Third-party vendors and suppliers provide various services for a clinical trial, such as:
- Study and protocol design and review
- Case report form (CRF) design and development
- Trial Master File (TMF) creation and management
- Database development and management
- Sample size calculations and power analysis
- GCP audits and training
Unfortunately, if vendors and suppliers aren't picked in a timely manner, the site activation gears get clogged and everything grinds to a halt.
#4. Negative Neuroses
Sponsors, CROs, and sites can be beset with an "I can't" mentality when it comes to scheduling:
- I can't schedule until the budget is finalized.
- I can't schedule until training is complete.
- I can't schedule until the IRB approval is granted.
- I can't schedule until the contract is signed.
- I can't schedule until all material is on site.
- I can't schedule until the drug is on site.
An "I can't" mentality guarantees that site activation will get sucked into a morass.
Which of the above have slowed down your clinical trials in the past? Which are dragging you under in the present? And, most importantly, what are you going to do to avoid getting stuck in the mud in the future?