Did you know that only about 20 percent of drugs used today are labeled for pediatric patients? By necessity, products licensed for adults are often given to children without adequate safety and dosing information or pharmacokinetic data. In fact, according to the FDA, most drugs prescribed for children have not been tested in children. Fortunately the pharmaceutical industry has begun responding to this lack of research, and government regulations and policies in the United States and Europe are providing incentives for the orchestration of pediatric clinical trials (source). Since the FDA introduced its Safety and Innovation Act in 2012, researchers have performed more than 436 separate trials to investigate how drugs affect children. With more pediatric clinical trials being conducted now than ever before, the number of drugs approved for use in children is expected to expand significantly.
However, designing a successful pediatric clinical trial can be challenging. One of the primary concerns is how to allocate the trial’s budget to attract and retain a sufficient number of participants.
Challenges of Recruiting for Pediatric Clinical Trials
A clinical trial must recruit enough participants to make it statistically relevant. While recruitment is often difficult for a clinical trial, it’s especially tricky when the trial is studying children. Parents want only the best for their children, so they may hesitate when faced with the prospect of subjecting their child to investigational treatments that may or may not produce the desired results. In addition, clinical trials targeting pediatric populations often face high drop-out rates. Before the trial reaches completion, a significant portion of the participants may quit because they find the process too rigorous or time-intensive, or they don’t think it fits into their schedule. If some of the participating families choose to discontinue treatments during the trial’s duration, it’s important that the trial has a sufficient number of participants nevertheless. For this reason, we recommend that pediatric trials start with a larger pool of patients than is required to reach statistical significance.
Solutions for Pediatric Subject Recruitment
When preparing pediatric clinical trial budgets, it is important to consider the challenges specific to this particular population. Given the need for high initial patient numbers and the anticipated high drop-out rate, allocating a slightly larger portion of the total budget to advertising and patient recruitment is advisable.
To garner attention for pediatric clinical trials and generate some buzz, it’s necessary to pay strict attention to the investment required for marketing and advertising. To deliver relevant advertisements to this narrow target audience, the media buying process should include the production of ads for television, radio, and print, as well as an investment in social media channels. Obviously, these advertisements will be geared towards parents and caregivers, not the actual anticipated pediatric study participants. Getting the word out across multiple channels is key to reaching an adequate number of potential participants.
Next, it is important that recruiters, trained in the nuances of pediatric trials, are ready to work with the families who respond to the media outreach. These professionals should be fully prepared to answer the families’ questions, explain the trial procedures, and move willing participants through the screening process for enrollment.
When pharmaceutical and biotech companies fail to put the right amount of money toward recruiting participants through advertising, marketing, and on-site recruiters, they often struggle to secure a sufficient number of participants for their trials – which can lead to a statistically irrelevant trial. For this reason, we encourage all sponsors to set aside an appropriate portion of the budget for marketing trials directly to the parents and caregivers of pediatric patients.
Since 1995, QPS has provided discovery, preclinical, and clinical drug development services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email [email protected].