We’ve all heard the statistics regarding the significant negative impact that low patient enrollment can have on drug development timelines and economics. Basically, it’s our industry’s version of telling ghost stories around a campfire. Typically, they start off scary and end downright terrifying: +90% of trials are delayed by at least one month; direct day-to-day out of pocket operating costs of more than $100K; opportunity costs of a $1M dollars per day and up… and on and on it goes.
How many presentations at DIA, starting off with these stats, do we have to attend before we go downright crazy and do something about it?
Thankfully, over the course of my career and a lot of trial and error, I’ve learned a few golden nuggets with regards to turning around slow-enrolling trials.
If you’ve ever had to manage a trial with underperforming enrollment levels (chances are, you have!), you know firsthand the headaches this can cause. Teams often feel overwhelmed and helpless. Thankfully, over the course of my career and a lot of trial and error, I’ve learned a few golden nuggets with regards to turning around slow-enrolling trials. Fortunately, in general, clinical trial sponsors are much more proactive when it comes to planning their study enrollment strategies and tactics. In fact, the number of enrollment rescue projects we support continues to drop annually, being increasingly replaced with proactive, well-planned enrollment enhancement programs.
There are certain pieces of the puzzle that can cause low patient enrollment levels, which should be addressed out of the gate:
- Protocol development and stakeholder input
- Study and site feasibility analysis
- Investigator grants, contracts and relations
- Availability of patient recruitment expertise and support at study sites
- Understanding patient volumes, catchment area and sources
- Contingency planning
- And much more
In order to combat low enrollment, you’ll need a solid plan of attack. This plan needs to be proactive, thoughtful, and aggressive.
For many sponsors, too often, the approach to addressing slow enrollment is to add sites and extend enrollment timelines. While that approach might ultimately be needed, there are things that can be done first to rally the troops and right the ship.
For example, sponsors may be tempted to conduct an aggressive and expensive direct-to-patient marketing campaign. For highly prevalent, chronic conditions, such an approach just might work. In today’s research environment, protocol complexity is increasing, and FDA burden of proof on clinical trials and drug approvals is much more stringent. Thus, finding patients for today’s study protocols often requires a different approach – one that has to leverage the expertise of the medical community to properly identify the correctly diagnosed patient and initiate a referral to study sites. A hidden benefit of this methodology is that approaching the medical community about your trial does not require an IRB approval. In a rescue situation, time is of the essence – a medical community outreach initiative can be executed quickly and begin paying dividends while you ramp up other initiatives.
This is just one of the secrets that come from years of experience supporting sponsors facing enrollment challenges.
What other tips have you found to be successful?