7 Magic Bullets To Boost Clinical Trial Enrollment

By Kunal Sampat, Senior Manager, Clinical Research, Abbott Vascular

You’d agree if I said, “Trial enrollment is one of the top priorities for sites, sponsors, and clinical research organizations.”

Clinical sites spend countless hours screening potential clinical trial patients. Sponsors spend thousands, if not millions, of dollars to enroll patients in clinical studies. CROs have full-blown teams just focused on patient recruitment efforts.

The number of patients enrolled per week (or per month), also known as trial enrollment rate, directly impacts the clinical trial budget and timelines. So it’s no surprise that we’re constantly in search of a formula that will solve our enrollment worries.

In this post, you’ll discover seven magic bullets that will get you closer to your trial enrollment goal. Even if you applied just one of these strategies today, you’ll start seeing results right away. 

Let’s get started.

1. Reimburse sites fairly

This magic bullet is for sponsors and CROs.

Many clinical research sites, especially larger hospitals, are nonprofit institutions. The only way they can run a clinical research department is to get funding through industry-sponsored research.

Not providing fair compensation for study startup, screen failures, and patient enrollment will likely demotivate your site. This in turn negatively impacts study enrollment.

So how can you reimburse sites fairly?

Sponsors need to translate their protocol requirements into the effort it will take for the research staff to find eligible patients.

At a minimum, sponsors can calculate the approximate number of hours it will take for the site to screen, obtain consent, and enroll patients. Once you’ve come up with an estimated number of hours, multiply it by the billable hourly rate for the site to perform that activity.

Site effort doesn’t stop with enrolling the patients and completion of the baseline or index visit. The site staff will need to continue patient follow-up, perform data entry activities, dig up patient records in the case of adverse events, and more. This takes time and effort, and sites need to be reimbursed for this work.

2. Show that you care and recognize each site is unique

Just as you and I are unique individuals with our own needs, wants, and desires, clinical sites are no different. Sites have their own specific challenges with patient recruitment.

Some common issues include limited research staffing for patient screening or interpersonal issues at the site. A sponsor or CRO must take the time to understand the roadblocks at each site and then work toward providing a personalized solution.

In my experience, many sponsors and CROs do a good job of assessing the enrollment issues faced by their sites. But when it comes to sharing and implementing solutions, everyone gets busy with the next important task at hand.

Once you understand the site’s recruitment challenges, follow up on the action items in a reasonable amount of time. If you cannot help the site, say so. But don’t go silent and fail to follow up after your enrollment discussion with the site research team.

3. Meet face-to-face, one-on-one

This is an extension of the previous point. Sponsors and CRO staff should meet site investigators and research coordinators face-to-face.

Face-to-face, one-on-one meetings are an excellent opportunity to really understand what’s causing enrollment to be slow.

This might not be easy. Site investigators and research coordinators are busy, and traveling to every site is not practical. Plus, the study budget is tight and there isn’t much money for travel.

But there is room to get creative here.

For instance, if you’re attending a scientific congress, it’s likely that representatives from some of your sites are going to be there, too. So why not email all your sites and ask if they’ll be traveling to the same conference as well?

You can easily book meetings using an appointment software such as Calendly. The software syncs with your Outlook or Google calendar and shows the other person the times you’re available. It takes away the painful emailing back-and-forth trying to find an ideal meeting time.

4. Provide useful and actionable information

You’re on a deadline to release your monthly clinical study newsletter. You open Microsoft Word, add the latest trial enrollment numbers, mention upcoming site visits, slap in some generic images, and hit “Save and Send.”

Guess what the majority of your recipients are doing when they see your email?

They hit “DELETE.”

As a sponsor or CRO, you want to create engaging content for your sites. It’s best to have a theme for every newsletter. And hiring a freelance graphics designer will pay huge dividends.

During the enrollment phase of the study, share enrollment best practices with other sites, showcase a high enroller, and do some “show and tell” so other sites can implement those strategies.

5. Collaborate on new ideas

It’s human nature to want to work on something new and exciting. Proactively reach out to sites via surveys and teleconferences to gather new ideas to improve your trial operations.

For instance, you may be working on an innovative investigator portal, a social media strategy to boost enrollment, or a publication plan. Brainstorm or get input on your plan from clinical sites. Take advantage of tools like SurveyGizmo to quickly set up surveys.

By opening up with sites and asking for their feedback, you’ll build trust and mutual respect, and sites will be more willing to prioritize your trial over others.

 

6. Set enrollment goals and meet (or beat) them

Sites, sponsors, and CROs should all have enrollment goals. These goals benefit everyone because when a trial completes enrollment on or before schedule, it’s truly a win-win for everyone involved.

The hard part of goal-setting is accountability. Here are some ideas on how you can ensure realistic goals are set and met:

• All sponsor personnel assigned to a clinical study should carry the trial enrollment goal. These goals can be tied to incentives such a bonus or a team outing when specific enrollment milestones are met.
• Sponsor contracts with CROs should have built-in bonuses for meeting or exceeding enrollment targets. When the enrollment target is met, a bonus payment is made to the CRO. Alternatively, CRO team members can be incentivized with rewards such as T-shirts or a company-paid meal.
• Incentivizing sites based on enrollment is usually frowned upon, and in many cases the value of the incentives is reportable to the government. For sites, it’s best to have internal goals for every study they sign up to participate in. Internal site goals can be similar to sponsor and CRO goals.

7. Publicly share enrollment success stories

What’s the point of doing great job with enrollment and not sharing your success story with others?

A great way to engage participating clinical trial centers is to publicly share success stories. Leverage your study newsletter, site-wide-conference calls, and investigator meetings to talk about past and current success stories.

Sponsors and CRO teams should also be encouraged to share successful enrollment strategies with others in their organization. This will not only bring visibility to the project team but also spark new ideas among others in the organization.

Sites should invest the time to create press releases, media outreach, or website content to publicize their involvement and efforts in a clinical trial.

Conclusion

You’re now equipped with seven powerful enrollment strategies that you can implement right away.

Here are the key takeaways:

• Reimburse sites at fair market value to keep them interested in the study throughout the enrollment duration.
• When troubleshooting enrollment challenges, providing site-specific personalized solutions will yield better results.
• In-person meetings between sites, sponsors, and/or CRO staff will provide you with intelligence on how to best address enrollment challenges.
• Focus on sharing useful and actionable information that will help sites with patient recruitment.
• Collaborate with sites on new enrollment initiatives, and make them feel they are part of the process.
• Set enrollment goals and meet (or beat) them to keep the excitement and momentum going.
• Publicly share enrollment success stories to boost study team morale and spark new ideas for existing and future trials.

Do you have a favorite magic bullet to boost trial enrollment? Share it with me in the comments section below.

About The Author:

Kunal is a senior manager of clinical research at Abbott Vascular and also the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to help you accelerate your clinical research career and be a more effective leader. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. You can find him on LinkedIn.