By Beth Harper & Audrey Rossow
As a CEO of a biopharmaceutical company, have you ever found yourself wondering the following:
If you answered yes to any of the above, you aren’t alone. The fact is — enrollment is difficult. It always has been, and it always will be. There are no silver bullets or quick fixes. It is complex, and there is no “one-size-fits-all” solution to fix it. But you can do something about it. What follows are insights for the simple things you can do to mitigate the most common problem that every study (with very few exceptions) will inevitably face.
BASIC FACTS TO RECOGNIZE REGARDING …
You may have a blind spot about the enrollment issues based on your focus on other issues, your passion for your compound, or your confidence in your team. It’s important to recognize that you can never truly outsource enrollment management. While you may be able to find phenomenal “child care,” ultimately, the study is your “baby.” No enrollment = no data = no answers = no approvals. While you can involve your CRO in the process, don’t expect them to own it. You also need to appreciate that enrollment is expensive; whether you pay now or later, either way you will have a significant investment toward achieving on-time enrollment.
Your Clinical Operations Team
No matter how qualified and experienced they are, they will be hesitant to call your attention to any issues thinking that they have things under control. The team is always thinking, “How do we tell the truth about enrollment in a way that it demonstrates reality without management hitting the roof?” They may want to be protective of the information or will want it to appear on track for fear of getting in trouble of some kind. So, they spend endless hours going through many machinations to vet and position the information, but this won’t hide the overarching reality (also their time could be much better spent on other things). The team will often manage all of this stress surrounding bad news by managing detailed site-activation status trackers and the like, setting up a pattern in which the data is scrutinized for the answers to the problem — the tail is now officially wagging the dog. Meanwhile, the enrollment problem worsens.
Your CRO Partner
Your CRO may have more incentive to add enrollment rescue services (via change orders and more costly interventions) than they do to achieve on-time enrollment, unless you have an air-tight performance-based contract. They also will quickly get paralyzed if they feel all the blame for poor enrollment has been shifted to them; after all, their internal KPIs may differ from the sponsor’s KPIs, a nuance that may create a fissure in the CRO-sponsor relationship, as well as the creation of the “elephant in the room.” Remember, they are not enrollment experts. Enrollment is a mix of art and science and can’t be distilled down to quick fixes. So, the tendency will be to turf the problem on to the sites (even though they supposedly selected the best ones possible through a rigorous site-selection process).
Unfortunately, sites are potentially rewarded for being overly optimistic about enrollment and disincentivized for being truthful about their true enrollment potential. They are hoping to be asked for input about the study design and its executability, and they will be honest about sharing the challenges and their study support and enrollment needs if you just ask them! Be sure to set realistic expectations of them and treat them like a valued study partner.
Now that we have your attention with some of the brutal truths about the enrollment problem, here’s what can be done to address them. While everyone would ultimately like more up-front time and preparation to establish more realistic enrollment timelines, the reality is that competitive landscapes, financial pressures, and an unrelenting determination to bring more meaningful treatments to patients will always drive the need to get enrollment done as quickly as possible. Let’s start with the dreaded rescue situation.
WHAT YOU’LL BE TEMPTED TO DO, AND WHY YOU SHOULDN’T DO THESE THINGS!
When enrollment starts to slip, study teams often default into the following go-to interventions, most of which rarely work.
By now you are getting the sense that we are strong advocates for conducting a thorough root cause analysis of the enrollment issue (Hint: There are over 150 reasons for why sites fail to enroll. Seriously. We have literally mapped this out!). We are also in favor of asking the sites what they need and creating site-specific solutions.
That said, there are times when it makes sense to bring in the expertise of a patient-recruitment services provider. There are currently more than 140 of these kinds of companies. Here are our top three recommended questions to ask when evaluating a potential patient-recruitment services provider:
What is your specific approach to providing site-specific support?
METRICS THAT MATTER
As the saying goes, you can’t manage what you don’t measure. The same holds true for enrollment. While study teams track typical metrics (the ubiquitous site activation and enrollment curves and screening/randomization rates), these often prove to be of limited value when it comes to actively managing recruitment and retention. Better leading indicators for managing site-enrollment performance include:
By defining expected thresholds and more systematically tracking these KPIs, you and your teams will get much better visibility into what is happening and areas to target for intervention.
PROACTIVE RECRUITMENT OPTIMIZATION — TIPS FOR SUCCESS
Beyond some of the “rescue interventions” and metrics suggestions that we have already outlined, our top tips for proactive enrollment management are included here.
TOP RECOMMENDATIONS FOR CEOS:
TOP RECOMMENDATIONS FOR CLINOPS TEAMS:
TOP RECOMMENDATIONS FOR CROs:
If there’s one thing to take from this crash course, it would be to appreciate that the science of understanding how to optimize enrollment is just as important as the science behind your compound! While this article just represents the tip of the iceberg, we are always available to share more insights, additional tools, and helpful resources with you.
AUDREY ROSSOW is principal at A. Rossow Consulting. She has over 20 years of experience in pharmaceutical and biotech clinical drug development.
BETH HARPER is president of Clinical Performance Partners, a clinical research consulting firm specializing in enrollment and site performance management and facilitating productive sponsor-site relationships.