January 15, 2019 | Participant recruitment is challenging across clinical trials, but in some instances—complex medical conditions, demanding protocols, particular resource constraints—the problem is even tougher.

The solution, says Kelly McKee, head of patient recruitment at Vertex, may not be easy, but it is simple: know your patients. “It’s extremely important to understand the patient population for every clinical trial you are recruiting,” McKee says. “Once you understand the drivers for clinical trial participation, it will be much easier to find the right mix of tactics to support your recruitment strategy.”

McKee and several of her colleagues will be hosting a roundtable discussion to explore strategies for patient recruitment in complex clinical trials at the upcoming Summit for Clinical Ops Executives, SCOPE, in Orlando, February 18-21.

To get the conversation started, McKee shared with Clinical Informatics News her take on recruiting trial participants in the most difficult of cases.

Clinical Informatics News: What approaches help recruit acutely ill patients when timing is critical?

Kelly McKee: Clinical trial recruitment is all about communication. It’s about creating opportunities for patients and their health care providers to become aware of clinical trial opportunities and have enough information about them to make an informed decision.

It’s extremely important to understand the patient population for every clinical trial you are recruiting. You can do this through: patient journey mapping; understanding the types of physicians and health care providers that patients are engaging with; reviewing the information available to patients on clinical trials; and assessing how a particular clinical trial opportunity fits into this paradigm. Once you understand this, you can design a strategic approach and associated tactics to engage patients, including communications around clinical trial opportunities. By developing these communications early in the process and getting them approved by Ethics Committees early (and before you really need them), you can deploy them in an expeditious manner should you need to engage patients quickly.

Do traditional/past tactics still work in current environment? What tactics (new and old) work best today?

The truth is that you can get any tactic to work if you put enough resources behind it; however, the ROI may be low and your timelines may be unnecessarily delayed. The question is, Is this the way that we should be presenting clinical trial opportunities to patients? Is a “Do you have xx disease, click here!” with a picture of a generic person really the messaging we want to continue? Is this helping our industry or harming our industry and the awareness of the importance of clinical trials?

It is important to first understand your patient population—who they are, where they go for information, how familiar they may be with clinical trial opportunities, etc., so you can make an informed decision on the right tactics for the right patient population and for the right study. It is also important to collect metrics and data so that you can measure the ROI to identify lessons learned and best practices for future trials.

Think about how YOU would want to be engaged in a clinical trial.  How would you want to be approached? What information would you want to have to make an informed decision? Talk to patients and investigators, research social media, and really get to know your audience. Once you understand the drivers for clinical trial participation, it will be much easier to find the right mix of tactics to support your recruitment strategy.

How do you ensure success for procedure-driven protocols, ones with non-conventional administration, or that are device or diagnostic intense?

As we all know, the world is not a perfect place and perfect patients rarely exist. This is where clinical trial teams can run into trouble and clinical trials can be delayed. Taking a more pragmatic approach and designing clinical trials that are aligned with real patients can better set your trial up for success. It’s important to have a balance between high tech and high touch. Teams need to spend time researching how a proposed clinical trial aligns with the standard of care to minimize additional or unnecessary visits and procedures that will not contribute to the study’s primary outcome. If additional visits and procedures are necessary, teams will need to ensure there is a value proposition established for patients. Is travel being supported? Are patients being asked to fast all day for blood draws that don’t contribute to the primary outcome? Think about involving stakeholders beyond the traditional trial team members (e.g., patients, patient advocacy organizations, study coordinators, investigators) to ensure that study visits procedures are logistically and socially feasible. At Vertex, we have conducted patient panels to answer some of these questions. The insights provided by real patients are invaluable. Simply put, a trial that is able to answer the scientific question at hand and is enroll-able is better than one that is scientifically pristine and unable to find any patients!