Operational Challenges of Neuroscience Clinical Trials, Part 3: Patient Recruitment

Last week, we discussed the high placebo response that plagues neuroscience clinical trials. Today we turn to another common challenge: patient recruitment. We’ll take a look at three strategies that can be used to improve trial participation:

  • the use of several patient sources when recruiting
  • a focus on patient-centric solutions
  • the use of patient recruitment advertising campaigns

Patient recruitment is difficult in almost all outpatient clinical trials, and neuroscience trials are certainly no exception. A 2013 report from the Tufts Center for the Study of Drug Development, which assessed more than 150 clinical trials worldwide across a variety of indications, found that nearly 40 percent of clinical trial sites fail to achieve their enrollment targets.[1]

Another study found that 80 percent of industry trials require additional time to meet target enrollment. Moreover, patient recruitment and retention are estimated to make up about three percent of total trial costs, which amounts to $2.8 billion annually. Depression and anxiety trials seem to be especially problematic in terms of patient recruitment.

Several sources of patients

To maximize recruitment of high-quality patients, it’s best to use a multi-tactic approach, drawing on multiple sources of potential patients to yield a diverse background of patients that represent the real world.

Potential patient pools can be accessed in several ways. Direct outreach — to advocacy groups and churches, for example — is one possibility. Finding patients through existing databases is another common method. Physician referral is a third option that is often utilized.

Patient-centric models of trial design

The drug development industry is increasingly moving towards a more patient-centric model of clinical trials. Patients are now considered core members of the clinical trial team, and increasing efforts are being made to provide patients with better education, to listen to and improve upon their concerns about trial participation, and to make it easier for them to participate.

A key component of patient-centric recruitment is understanding the so-called patient pathway. How are patients getting into clinical trials? What are the motivating factors for each patient? Finding answers to these questions through techniques such as social listening (the process of monitoring digital conversations) can lead to new ways to recruit patients.

Patients can’t participate in clinical trials they aren’t aware of, so another strategy that is becoming increasingly popular is focused on improving patient access to information about potential clinical trials. Advocacy groups and patient communities such as Raremark are proving to be very helpful in this regard.

Patient recruitment advertising campaigns

A third effective strategy is to recruit patients through advertising. However, caution must be used when taking this approach in order to guard against financially motivated patients who participate in multiple clinical trials and even multiple sites within the same trial. The “quality” of the recruited patient should always be an important consideration, and sources of trial participants should be taken into account when performing analyses of placebo response and other potential trial pitfalls.

For more information on our patient recruitment capabilities, contact Premier Research today.

Read more:

Operational Challenges of Neuroscience Clinical Trials, Part 2: High Placebo Responses

Operational Challenges of Neuroscience Clinical Trials, Part 1: Overview 

[1] Tufts Center for the Study of Drug Development. (2013, January/February). 89% of Trials Meet Enrollment, but Timelines Slip, Half of Sites Under-Enroll. Retrieved from https://csdd.tufts.edu/impact-reports/

Author Details

Krista Armstrong
Krista Armstrong, Ph.D. oversees the overall execution of Premier’s Strategic Development Strategies, and is also responsible for oversight of the Executive Director Leadership Team for the company’s neuroscience, oncology, general medicine, pediatric, and rare disease portfolios. Her primary therapeutic and operational expertise is within neuroscience, with a specific emphasis in psychiatric indications and neurological conditions, such as ADHD, bipolar disorder, autism, addiction, Alzheimer’s disease, Parkinson’s disease, and stroke.
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