• by Neil Weisman , May 22, 2012

There are many factors that drive patients to the doctor’s office, but—ultimately—the doctors are the gatekeepers of patients’ prescription drugs. To achieve blockbuster success, pharmaceutical companies need to have physician ambassadors who fully understand their product and its benefits to increase their likelihood of prescribing it. The same holds true for recruiting patients for clinical trials. Clinical development teams spend considerable resources to drive patients to the physician’s office to recruit them for a clinical trial. Once the inquiry is forwarded to the site, however, the pharmaceutical company must rely on the staff at the doctor’s office to “sell” its research study.

For clinical trials, study coordinators are the gatekeepers to enrollment, as they are the ones who largely run the clinical trials. Similar to physicians, sponsors must educate and inspire coordinators to ensure they follow up on leads generated from advertising, as well as querying their own practice database.

Like physicians, coordinators are busy. They are continually being asked by multiple parties to provide updates, make corrections and gather additional data. Coordinators have numerous systems they must access to do their job, often multiple ones for a single study. So, how do you break through the clutter, keep study coordinators engaged and make sure your patient recruitment program is top of mind? Here are several steps we have found to be particularly effective:

Motivating

First and foremost, get coordinators excited about the study and the recruitment support being provided. What makes this trial unique? What can you provide to make their job easier? How can you show the coordinators that they are truly valued? Before the study begins, consider sending “Excitement Kits” to sites. These kits feature a collection of materials and tools that motivate coordinators to succeed, and that express your appreciation for the effort you expect them to soon put forth. Branded items that coordinators can place on their desks, such as notepads, mousepads and organizers (which, by the way, are allowed for clinical trials) also serve as constant reminders of the study. Be sure to keep all materials strategically aligned to the goal of the study. 

Set goals for your coordinators -- both short and long-term -- hold them accountable, and enthusiastically acknowledge when goals are approached or met. Contests and raffles are great ways to motivate coordinators to meet their goals. The prizes can be as simple as nominal gift cards for any site that meets a specified goal, such as following up on all their leads, or meeting other enrollment benchmarks.

Training 

Coordinators need training to succeed. Make sure they understand how to position the study to interested participants by highlighting the value proposition in a simple and accessible manner. Confusion in the consent process often serves as a significant barrier to enrollment. To combat this, provide patient-facing resources to the coordinators such as handouts, flip charts, or a prerecorded, simplified version of the informed consent form. Doing so can help transform legalese into a patient-friendly experience, thus converting something that was previously a barrier into an opportunity.

Study coordinators must have a full understanding of the elements of the recruitment program, and how they will be required to utilize those elements. Consider setting up an introductory webinar that trains coordinators on program elements, systems and expectations.

Enlisting Leaders

Reach out to the coordinators at successful sites and ask them what they’re doing that has worked well. Not only will it make them feel appreciated, but you can also publish their tips to share with other sites. In addition, it’s nice to foster direct peer-to-peer dialogue when appropriate.

Ongoing Communication and Evaluation

Until the randomization goal is met, it’s important to actively communicate with sites. Keep close tabs on sites’ progress, so that you can make changes as soon as possible if they become overwhelmed with leads. Maintain a balance between being as friendly and helpful as possible, while still holding sites accountable for getting their jobs done. 

The greater the engagement at the site level, the greater opportunity each site will have to increase enrollment. Providing motivation, inspiration and tools to the sites helps pharmaceutical companies complete their trials on time and bring their products to market sooner.