April 10, 2018 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Janet Lewis, RN, CCRP, a consultant at J. Lewis Consultants.

Janet, what do you think it’s about time for the clinical research enterprise to start doing?

It’s is about time we get everything in place for first-subject-first-visit (FSFV) before we start scheduling visits and seeing subjects.

This may sound like a stupid question, but why is that a problem?

I wish it were a stupid question but, apparently, it’s not. I’ve heard so many times that the contract is holding things up, but it might be something else, or a lot of different things. The protocol might be changing, or training access might be delayed, or visit kits have not been received, or the EDC system might not be ready so source documents cannot be created, or the randomization system might not be accessible, or point people might have not been identified, or study IP might be delayed, or everyone’s contact information might not be available to everyone, or paper or eDiaries might not be ready. That’s just a recipe for chaos.

Everyone needs to be communicating — finding the problems and deciding how to fix them. Unless you work all sides of the equation to figure out all the possible hold ups, you are not going to solve this problem. Everyone will just be playing catch up, spinning their wheels, and pointing fingers at each other. That’s a bad way for a “team” to start off.

So, what’s the solution?

You don’t launch a rocket into space until the launch manager gets a “go” sign from every part of the team. Clinical studies need launch managers to push the button and hold everyone accountable — no excuses— for doing what they said they would do to get the study started properly. Too often we try to launch with missing parts. We think we can do it but we usually can’t, at least not efficiently and not without errors.

Do you mean all the sites too?

No, not every site, only the ones that are ready for FSFV, but they really have to be ready, not conditionally ready based on someone else doing something. In vaccine studies, for example, subjects are scheduled assuming everything is in place. If it’s not, all those visits need to be rescheduled and some subjects will drop out before the study even starts.

That seems like a reasonable solution. How many sponsors or CROs seem to use it?

Not enough. I’m sure every sponsor and CRO has the intention but, all too frequently, we get to the FSFV date and find a big mess.  All members of the study team — sponsor, CRO, IRB, site and venders — need to communicate and work together for a smooth startup.

Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information services. Contact him at 1.650.465.0119 or ngoldfarb@firstclinical.com.