Clinical Trials: Turnaround Times and Deadlines are Critical
Posted on Tue, Sep 08, 2009
Today, our guest blogger Mark Wade talks about what is important in clinical trials...
Finally empirical evidence that turnaround times and deadlines are mission critical in clinical trials. A staggering 19 out of 21 pharmaceutical companies surveyed by Cutting Edge Information ranked a contract research organization's ability to hit trial deadlines as either "extremely important" or very "important," making it the top quality identified by respondents.
The report, titled: "Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships" gathered data from a cross section of Pharma companies.
- Six were large, global pharmaceutical or biotech companies with multiple approved products and earnings of over $10bn dollars
- Five were medium-size companies with at least one approved product and earnings of over $1bn
- Five participants were small pharmaceutical companies without an approved product on the market
While the report notes that Pharma companies understand that there are unavoidable unforeseen delays possible in trials, it is the CROs 'real world' experience and ability to deal with these issues that sets some apart from others.
So what does that mean in terms of translation? Well, consider that each of the necessary documentation needs to pass at least once through an Independent Review Board (IRB) before the documents become final. If you also consider that CROs often receive several versions of the final documents from the Sponsor before they become final with very little time to spare before sites are supposed to go live, then the challenge for language translation becomes clear.
With a Sponsor focused on working closely with their CRO to ensure that documents are signed off and CROs focused on having sites prepared for the first day of patient enrolment, it is very easy to push language translation down the priority list. The problem with that is that if you do not have the patient facing documents translated, you cannot enrol your first patient!!!
It appears to me that it is becoming more important everyday to work hand-in-hand with the CROs and Sponsors to ensure that any translation that can be done upfront. The risk of leaving all translations until the last few days has too much of a risk profile i.e. no first enrolment...significant increase in non-recoverable costs!