It’s fairly well accepted in today’s clinical research environment that proactive strategies for driving enrollment in clinical trials are part of the complicated equation of success. According to a 2016 survey of study sponsors conducted by Imperial, nearly 55 percent of sponsors develop formal recruitment plans, while another 26 percent turn to their CRO, who may or may not actually develop such plans.
If you’ve attended conferences on clinical research, you might have heard case studies and success stories from sponsors and vendors about their recruitment programs. Of course, there are horror stories out there as well. Most of them go something like this: “We spent a lot of money on a recruitment program and we really can’t say whether it worked.”
Without good tracking, it’s probably safe to say that every stakeholder would want to take credit for enrolled patients. Study teams, CROs, and sites can all speak for themselves, but recruitment initiatives cannot – at least not without having proper tracking mechanisms in place. Unfortunately, many sponsors (nearly 48 percent) aren’t tracking the performance of their recruitment initiatives, according to the Imperial survey.
Sponsors told us the number one reason for not tracking the performance of recruitment initiatives was the lack of time and resources to do so. The fact is, making the decision to implement recruitment initiatives is probably the easiest part of the program. The tracking is perhaps the most difficult. It can be tricky to determine where patients originated, and it’s also hard to find the time or people to do the tracking.
Fortunately, there are a variety of options available, depending on the types of initiatives you are using. Below are just a few that you might consider. Like many decisions in life (build vs. buy, for example), sometimes the best decision is to bring on a partner with the expertise and resources to give recruitment program execution and tracking the time and attention necessary.
Here at Imperial, we often find small to mid-size sponsors come to this realization. Successful enrollment takes a level of attention and tracking that most small sponsors are unable to commit to internally. If you decide to go it alone, consider some of the following:
- Develop an online screener and email referral routing and tracking system
- Hire a call center with live support
- Utilize an automated voice response or text response system
- Create dedicated phone numbers and/or codes for different advertising mediums
- Train and incentivize sites to track the source of referrals
That is just a sample of the types of tracking approaches being used. If you’re going to spend the time, resources, and money to implement a patient recruitment program, make sure that you have accounted for proper performance measurement and management. Part of a successful patient recruitment program is tracking whether your program was successful.
About the Imperial Sponsor Survey
Starting in May 2016, Imperial surveyed more than 160 line managers in clinical operations at sponsor companies across the world. This first-of-its-kind survey aimed to understand the attitudes and behaviors of these individuals related to patient recruitment. All are critical stakeholders in one of the most important functions with regard to the timely and cost-effective development of new drugs. The impact of slow enrollment in clinical trials is well known. What isn’t particularly well known is how sponsors tackle this challenge and how important of an issue it is internally. Specifically, Imperial wanted to identify:
- Who participates in the decision-making process
- What the work environment is like, including pressure and stress levels
- How closely do they track enrollment performance
- What tactics do they employ to drive enrollment
- What resources or support do they leverage to improve enrollment
Updated 11 January 2023
