No one wants to be picked last for a team. Often in the clinical trial process, that’s what happens. All the preparations and planning are completed and the last thing sponsors and CROs think about is the sites. At least, that’s what it feels like to the sites. They’re the last kid picked for the team and it’s hard to feel like a part of the team when that happens.
The more involved or engaged a site is with the sponsor and the project, the more motivated they are to put extra effort toward the study. They feel a sense of ownership and connection – even a duty – to perform well. Engagement of clinical trial sites can make the difference between completing recruitment on time and a study that misses the target.
Many sponsors and CROs equate site engagement with site contact and the more frequently the site is contacted, the greater engagement there will be. The belief is that the frequent contact will result in a stronger relationship. Unfortunately, this generally backfires. Engaging the site is not weekly calls to check to see how the site is recruiting. Weekly phone calls that serve no benefit to the site are a waste of time, irritate the site and may cause them to withdraw mentally from the project.
Instead, engagement through involvement begins long before the study starts. Involvement should begin as a study is conceived. If you are a sponsor that works in a therapeutic area, start engaging sites and investigators long before your protocol is drafted. Most sponsors will have an advisory board that includes perceived “key opinion leaders” or “KOLs”. Newsflash, most often the key opinion leaders are not the ones who will enroll significant numbers in your studies.
Instead, work to identify who the sites are that will contribute significantly to the study. This is a critical step and one most sponsors leave up to the CRO to determine during feasibility once the protocol is finalized. It’s too late at that point. Instead, form a site council – include representatives from those sites you want on your study, and who you expect to perform well. Have them give operational input for your draft protocol and vendor selection. It will cost a small amount compared to the cost of not recruiting on time.
By involving a larger group prior to the study, it will also create a buzz about you company. Word will get around that your company seeks site input in your plans. You will then start to be perceived as a sponsor that values clinical trial sites.
Involve sites by requesting input on the potential vendors for the study. The most common path in a clinical trial is that everything is decided by the sponsor and CRO and then the site is informed what they must do. Mistakes like choosing a vendor that sites despise can cause sites to disengage. I’m not saying that decisions should be made by committee. However, have you as a sponsor or CRO ever asked sites what their experience has been with certain vendors? I get it, for large sponsors, it’s complicated, they’re limited in the vendors they can go to. At least if sponsors got input from the sites, those sponsors might be better informed about what problems to expect. Perhaps some issues could then be minimized or averted.
Many sponsors and CROs now have site relationship teams. They may have different names, but the site relationship team is a valuable role and can help increase engagement with sites. The individuals in these roles are a treasured resource for sites. They should be empowered to be an advocate for sites internally within an organization. If your company does not have a site relationship team or unit, start introducing the concept.
In my youth I played many team sports. Many years ago, I started coaching. Playing team sports and coaching has taught me many valuable lessons. Each player on the team is valuable to the success of the team. Unfortunately, in clinical trials, often sites are made to feel like not only are they not an integral part of the team, they’re not even a member. This disconnect is generated by the sponsor and CRO when they view the site as their subordinate who is to follow instructions blindly because “the sponsor and CRO know best”. Reality check, this is not the case. Take a minute and remind yourself the following:
- The investigator is the expert in the medical care of the participant
- The experienced site is the expert in the operational conduct of a clinical trial
If the site is properly engaged and involved as a full team member in a clinical trial, the whole clinical trial can benefit. If they’re treated as a subordinate, the study will suffer and the sponsor / CRO will lose good sites. Sites will only put up with so much before they disengage.
Simply put, as site involvement increases, motivation also increases.
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