The 4 “I”s of Investigator Motivation – Impediments

I think there is a significant desire at sites to operate at a high level. When site selection for a study is accepted, there is a genuine hope from all involved that the study will go well. Unfortunately, there are often many things that get in the way of that lofty goal.

Clinical trial impediments are issues, actions or problems that keep the study from starting and/or running smoothly. Delays in start-up, problems receiving study supplies, problems with contract and/or budget negotiations all impede the timely start and execution of the trial.

When clinical trial sites plan for a study, the schedule that is laid out prior to the start of the study is critical to its success. When things come up that cause that schedule to be postponed or delayed, it affects the site’s ability to function effectively. Sites that run many studies consider the timing of new study starts when they decide to take on a project. If that project is delayed, they may not have the same time to devote to the study because other projects are continuing according to their appropriate schedules.

Sometimes the delay in study start is with contract and budget negotiations. I love the question on feasibility questionnaires that asks how long it takes to finalize a contract. The truthful answer is often “well… it depends how long it sits on someone’s desk in the sponsor’s or CRO’s legal department”.

Supply issues create additional work for the site that they are not paid to resolve. Often, the cost to the site both financially and in lost opportunity can be significant. A clinical trial site has expenses and needs to function efficiently to cover the cost of those expenses and priority will naturally be given to the study that is operating on schedule and not affected by delays or supply issues.

How do we work to decrease impediments in clinical trials?

1. Set realistic start-up timelines and communicate those to sites. Most studies do not start on time. Pressure from senior management to initiate a first site by a certain date often leads to other sites not being prioritized for start-up and they may start weeks if not months later.
2. Work with vendors you know and that your sites have a good experience with. (Do you know if your sites have a good experience with a vendor you use for a study? – that would be a beneficial thing to learn). If you’re looking to engage a new vendor, reach out to your trusted sites and solicit their experience in working with the vendor. Then (and this is really important) listen to what your sites are telling you. If they’ve had problems with a vendor in the past, 99% of the time the vendor hasn’t fixed those problems no matter what the vendor salesperson might say. If your experienced, trusted sites haven’t used a vendor before – that’s likely a big red flag.
3. Clinical trial tech is constantly evolving but be aware that every piece of tech added to the study will likely impede the site’s ability to conduct the study visits efficiently. The tech may provide advantages to the sponsor or CRO, but often comes at the cost of more time spent by the site. As time to conduct the visits along with the associated admin time increases for sites, the fewer visits they can conduct in a day. These time costs are often not apparent until after the site starts the study. At that point, decisions are made about which studies should get more attention because they are easier to conduct. The lesson here – be very selective about the tech to add to a study. Very few clinical trial tech solutions provide benefit to sites and make visits easier to conduct.

Sometimes things do come up that are out of everyone’s control. When that happens, communication is the key. “Early and often” to keep the sites informed of the status of the situation. Once the situation is resolved, it is not the time to hound the site about recruitment – citing the fact that they committed to a certain recruitment level. The delay they just experienced in your study, means other projects started or hit data locks or there are other pressures that now complicate the matter. Instead, the communication should be to acknowledge the delay in the study and take a partnership approach to ask the sites what the sponsor can do to help get the study back on track. This may mean providing additional advertising funding or other resources to the site. Caution – this is often a time when the CRO and Sponsor come up with grand ideas on how to solve site problems and implement them before asking the site what they need. All this typically does is put more money in the CRO’s pocket and the solution usually just serves to irritate the site (wait, Irritation is next week’s post).