This question was common at site selection visits during my time as a clinical research coordinator. By competing, what the sponsor typically meant was a similar trial enrolling concurrently with theirs.
It’s a logical question, but this question can obscure an important point about patient enrollment.
Every clinical trial that is not yours is a competing clinical trial.
Clinical research sites have finite resources. And with research sites being asked to take on more and more duties, those resources are only getting more strained. Here’s what this reality means for patient enrollment.
If research site staff are working on other clinical trials, they are not working on your clinical trial. Nor are they working on patient recruitment for your clinical trial. To excel at patient enrollment, you need to maximize the time and energy that sites spend recruiting patients for your clinical trial.
That’s pretty obvious, right? But how do you do that?
Understanding the Research Site Perspective
First, you have to understand an important part of the research site perspective. For research sites, the allocation of patient recruitment resources is about far more than patient recruitment itself.
Ultimately, it’s about commitment. Let me explain.
Each time a research site enrolls a patient for a clinical trial, they are making a commitment to see that subject through to the end of the trial. Which means that they are also making a commitment to work with the sponsor on the trial over that period of time (and beyond).
If the prospect of making such a commitment is exciting, sites will prioritize patient recruitment for your trial. If the prospect of making that commitment is unpleasant, sites aren’t exactly going to jump through hoops to enroll patients.
Focus Relentlessly on This Goal
So here’s what you need to do.
Make research sites prefer working on your trial more than that of other sponsors.
This advice is my single best recommendation to maximize patient enrollment. If you relentlessly focus on this goal, two things will happen:
- You minimize the chance that you have to work with Rebar Interactive or another patient recruitment company.
- If you do work with a patient recruitment company, research sites will prioritize the referrals generated for your clinical trial. Or in other words, you will get better ROI.
This strategy also has a host of secondary benefits:
- Your queries will get answered faster.
- The overall quality of site work will be better.
- You maximize patient retention.
- The list goes on.
So what tactics can we use to achieve this end?
The Sponsor Cheat Sheet
I recently came across a series of blog posts that are excellent guidance.
As I was reading these blog posts, it was evident that they were written by a very experienced CRA. And more importantly, it was evident that they were written by a CRA who understands the needs and motivations of research sites (not all experienced CRAs do).
Nadia at the Lead CRA blog wrote a 3-part series on improving relationships with sites and investigators. Read it. Bookmark it. Print it. It’s great stuff.
Every Decision Ultimately Impacts Patient Enrollment
As you read Nadia’s recommendations, note the diversity of them. This point is important.
Most decisions you make, as a sponsor, effect how enthusiastic sites are about working on your clinical trial. And that enthusiasm will determine how many resources sites allocate to patient recruitment for your clinical trial.
- Is your drug one that PIs don’t feel excited to present to patients?
- Do research sites dislike working with the vendors you have selected?
- Is your inclusion/exclusion criteria impossibly difficult and discouraging?
- Do your CRAs have poor communication skills?
- Is your EDC system user unfriendly, slow, and buggy?
- Do research sites continually have to hunt you down to collect payment according to the timelines in their contract?
If you find yourself often answering yes to questions like these, you’ve got problems. Forget social media or whatever trendy solutions you are considering. That’s like rearranging deck chairs on the Titanic. It’s time to get back to basics.
Just about every decision, regardless of whether it appears directly tied to recruitment, will impact patient enrollment in one way or another. Early trial decisions that may seem cheap or easy in the beginning can prove costly or complex in the end.
So here’s a simple habit that will set you up for success with patient recruitment and beyond:
When making these decisions, ask yourself how they might impact site motivation to work on your trial. And while you’re at it, ask yourself how they might impact patient motivation to participate in your clinical trial.
Getting into that habit will pay big dividends.
To be clear, I am not suggesting that sponsors cater to every site and patient whim. What I am suggesting is that sponsors view sites and patients as partners. And that they consider what these partners need so that everyone can succeed.
A Systems Approach to Clinical Operations
What I am essentially advocating is a systems approach to clinical operations.
This approach has been adopted in the wider US healthcare system with great results. Back in 2011, I wrote about what we could learn from the US healthcare system’s adoption of a systems approach.
If you’d like to read more on that topic, check it out here: