Insights Into Clinical Trial Recruitment Trends

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Are you searching for patients that don’t exist? With the rise of social media and increasingly rigid trial protocol, clinical trial recruitment has inevitably become more complex. PRA Health Sciences’ Gretchen Goller, Sr. Director of Therapeutic Expertise-Patient Access and Retention Services, provides insight into the changing landscape of trial recruitment and highlights some best practices for efficiently enrolling trial participants.

Anna Rose Welch: What are some of the overarching changes in the clinical space/recruitment process that have made enrolling participants more difficult?

Gretchen Goller: One of the biggest factors has been the change in clinical trial design. Protocols have become much more complex with very stringent inclusion/exclusion criteria, which often lead to a search for patients that seemingly do not exist.

Similarly, as protocols become more complex, the standard of care (SOC) changes in mostly all therapeutic indications, resulting in changes to the procedures and testing that is being used. For instance, if a protocol is written at the beginning of the year, by June, elements of how patients are treated could change, making it potentially harder to identify patients with those exact inclusion/exclusion criteria from the original protocol.

I would also say that it is important to consider how changes in healthcare, especially in the U.S., have impacted the clinical space. As patients have more treatment choices and access to healthcare, there may be fewer eligible patients that have interest in participating in a clinical trial. With so many treatment options and not enough positive press around clinical research, the choice to be in a clinical trial is less desirable. In addition, as patients become better controlled in various indications, their ability to meet specific criteria may be affected.

Welch: As trial protocols continue to lead you on a search for candidates that “seemingly don’t exist,” do you have any best practices for enrolling participants and reducing the delays that can occur in the recruitment process?

Goller: The very best strategy for reducing delays in enrollment is to plan ahead. During the study design planning, there should be an in-depth discussion about the origin of the patients and their pathway into the trial. Operationalizing the trial is crucial, as it is imperative to assess whether a patient and site can logistically and comfortably perform all procedures during each study visit. It is important to create the recruitment plan during the feasibility process. Ask how, when, and where will these patients be identified. What additional support will the sites need to supplement their own organic pool of patients? Depending on the indication, there are recruitment strategies that are more effective and yield a better result.

Welch: To what extent have you been using social media as a trial recruitment tool, and what are some things to consider when handling recruitment through these channels?

Goller: Social media is just that – a tool that is a part of a vast tool box for identifying potential patients. It is also a tool that can be used for a great number of other things – from communicating study results and patient experiences to what you had for dinner. However, it is important to be educated and strategic when using social media. Various sponsors and CROs have clear and not-so-clear policies around what can and cannot be posted using social media channels. Like any other medium, you need to do your research on the indication you’re targeting to determine what outlet would work best and why.

Welch: When it comes to targeting rare indications in particular, how do you go about recruiting patients?

Goller: For the sake of clarity here, rare diseases, per the NORD definition, is any disease state affecting less than 200,000 Americans annually or a disease or disorder in Europe that affects less than 1 in 2000. Often, there are minimal solutions, treatments, and information available to rare disease sufferers and their caregivers. Because of this, rare diseases do not receive consistent media attention (if any), and public (and professional) awareness and education of rare diseases is minimal. As a result, online communities are often born out of a need for more information by patients and caregivers.

In order to best recruit this demographic, you need a multi-tiered holistic approach to identify and educate patients with a rare disease. Some of these strategies can include:

• disease state and study awareness
• advocacy group activation
• grassroots advertising
• paid advertising
• patient, caretaker, physician, site education & recruitment materials
• in-network materials and tools
• site motivation tools
• in-market and/or remote support from clinical enrollment specialists