Recruiting patients for clinical trials is not as straightforward as it may seem. Identify­ing patients that match the inclusion and exclusion criteria can be an immense task on its own, yet it is not simply the identification that leads to successful enrollment. In order to collect optimal data, it is imperative to communicate, motivate and activate those patients who are willing to invest their time as participants.

Communication of the clinical trial oppor­tunity is where it all begins. In order for clinical trials to be considered an option, people need to know about them. According to the Tufts CSDD presentation titled, “Building Trust, Engaging Communities and Disseminating Results,” based on a CISCRP survey, only 19% of the 8,857 people who had never participated in a clinical trial self-reported that they had a high amount of knowl­edge and were informed about clinical trials.

Another CISCRP survey revealed that 51% of people would prefer to get clinical trial information from their primary care provider, but only 23% of those surveyed actually do. On the other side, only 17% of people prefer to get information about clinical trials from newspaper and television advertisements, but 33% of those surveyed cited newspapers and television as a source of clinical trial information. I suspect that if more primary care providers discussed clinical trials with their patients, it would lead to an uptake in the percentage of people that report having a high amount of knowledge and feel informed about clinical trials.

Motivation is another hurdle that must be overcome to successfully enroll a trial. Although study teams augment different types of outreach, study teams primarily rely on sites to provide patients from their own databases in clinical trials. Sites may go through their electronic medical records and identify 20 patients that meet the criteria for a particular trial. Without motivation, there may be 20 names from a database and zero randomized patients. Undoubtedly, it is difficult to motivate someone to participate in a study when you can’t say whether or not they will be receiving an investigational treatment or placebo, when there are multiple site visits that take time from other responsibilities and when it may involve procedures that may be outside their normal standard of care.

Good communication is crucial to motivating people; simple things can be done in doctor-patient discussions like removing power dynamics in certain settings. For example, ensure that a patient is treated as an equal in decisions, and that clinical trial discussions do not occur while the patient is sit­ting and the physician is standing. Peer motivation is also influential. If someone at the site participated in a clinical trial and had a good experience, it may be beneficial for them to speak to others. Most im­portantly, patients should be asked about what they want from their healthcare, what they value about research and what it would take to get them to consider a clinical trial. Without motivation, they may be informed that there are clinical trial opportunities but not feel a vested interest to participate.

Activation is the height of awareness and motivation. An activated patient fully partici­pates in their care and maintains that behavior over time, according to Judith H. Hibbard, DrPH, Health Policy Research Group University of Oregon. She explained that activation is developmental and there are four levels. Level 1—People take a role. Level 2—Build knowl­edge and confidence. Level 3—Take action. Level 4—Maintain behaviors.

She describes a measurement tool called Patient Activation Management (PAM), which is used to measure a patient’s activation. Her work looked at over 100 studies and determined that “higher activated individuals are more likely to engage in positive health behaviors and to have better health outcomes.” The link between patient activation and patient recruitment should not be overlooked. Most of the behav­iors that we ask of clinical trial participants may only be successfully adhered to by those with the highest level of activation. Creating study responsibilities that match the activation of your patients or matching only highly activated patients with studies that involve complex and difficult behaviors is a good place to start.

Study participants play a huge role in research and the tasks we ask of them should mirror their activation.

With great communication, stellar motiva­tion and a high degree of activation, patients can confidently choose to not only enroll, but complete their journeys as participants in clini­cal trials.

Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment exper­tise, strategy and leadership as Principal Consul­tant of Accelerate Clinical Enrollment LLC. Email tointon@icloud.com or tweet @AshleyTointon.

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