Henry Ford Health System on their Clinical Trial Reorganization
Henry Ford Health System made organizational changes to prioritize clinical trials across their entire hospital system. A year into the reorganization, Dr David Lanfear, VP Clinical and Translational Research, Henry Ford Health System, gives an update on the process.
Why was the reorganization done at Henry Ford Health?
Our clinical trial business is substantial and being able to work through all the agreements in a timely way is pretty demanding. Our efforts to centralize things were a way to get help that's flexible and scalable, and to do things more consistently.
For example, we had a central office for contracting but budgeting was done by departments and coverage analysis was being done at the investigative level. We’ve centralized those two components. We’ve had to go through that journey, to understand how to make doing clinical trials smoother, faster and more integrated.
A year after your presentation, how is the reorganization going?
It's not going as fast as I would like, but it's probably going as fast as it could be done, as we do multiple things at once. One change has been outsourcing. We’re also making organizational changes and rolling out a CTMS and electronic regulatory binder. Particularly with outsourcing, there is a lot of work involved in transitioning to that model. As turnkey as it can be, there are still a lot of moving parts in adopting a new system, especially on the scale that we’re doing it.
"Through our service provider relationship, we’re also getting national comparators (de-identified institutions) to get a sense of where we are versus others"
What have you learned throughout the process?
You can never communicate enough. We tell everybody what’s going on, what the plan is, and even still, members of my team will say, “Oh, this is new.” Some people might perceive that there’s a lack of communication, but it may just be inefficient or insufficient communication. Laying out procedural maps as much as possible helps, even the steps needed to start a trial.
Through our service provider relationship, we’re also getting national comparators (de-identified institutions) to get a sense of where we are versus others in terms of processing time, or what the distribution of trials across therapeutic areas, etc. That’s a nice bonus of our outsourcing relationship.
What did you outsource, versus keep in-house, and why?
We focused the outsourcing on clinical trial work. We're sending out coverage analysis, contract and budget negotiation, as well as IRB. We do have, however, our own internal IRB for non-clinical trial work. We’ve kept billing, invoicing and accounting in-house. The things we kept in-house, we did so because we felt we didn’t have as big of a need there, and it would be almost as much effort to outsource as it would be to continue to do it ourselves.
"We’re learning, with our vendors, how to optimize their negotiations with whoever the sponsor is on our behalf."
What are you learning about working with outsourced vendors?
We’re learning, with our vendors, how to optimize their negotiations with whoever the sponsor is on our behalf: how tough they need to be, how long they have to negotiate, and the prioritization of time versus cost. This is a change from when we would negotiate ourselves: we didn’t have to tell somebody else how long they should wait, how many back-and-forths are reasonable, or when to come back and say, “We're going to have this sticking point in the budget.”
Part of the reorganization was the ongoing process of workforce development. How is that going?
One of the biggest complaints from our investigators was the inability to hire and keep staff. We would train people up and then lose people. Over time, we ended up with too many job descriptions. That needs to be pared down, and there must be a clear career progression. We are focusing on training people, paying them adequately and having career progression so that they are happy to stay.
One challenge we’re facing is development, training and getting new people’s foot in the door in the first place. We still don’t have a great standard about what our future clinical coordinators look like. That’s very important to address. Do they have to be nurses? What backgrounds can they come from? How much of an education is actually required for various roles? We need to continue to focus on that so that we can open up supply because it's hard to find good people to join the team.
"One challenge we’re facing is development, training and getting new people’s foot in the door in the first place."
For all the changes you made, how did you get buy-in from your staff?
We had buy-in from above because there was the realization that we had grown over the years, and that we needed more structure to continue doing this work at that scale.
We had buy-in from the folks on the ground by acknowledging that we would be making changes, but that those changes would help them and not make their lives harder. Rolling out the CTMS, beginning the outsourcing process, etc, required our staff to learn new processes, but the entire time, we emphasized how this would help: how this would help get our time to activation down; how this would give them help with budgeting; how this would satisfy our regulatory requirements, etc.
What is your advice for other hospital systems that are trying to do clinical research or trying to do it more effectively?
You must make sure it’s customized to your needs, your processes, and your scale. A lot of it depends on scale. If you’re a midsize institution like ours, with several different areas and substantial clinical trial efforts, you have to build the infrastructure. That might mean either keeping a big enough in-house team to supply budget, coverage analysis and contracting, or you have to outsource it.
You also have to be able to track your data. We were late getting on the CTMS bus, but it’s going to be very useful for knowledge and data-tracking; we’re going to have real metrics on our activities.
To learn more about the reorganization process, click here
