Lou Shapiro
In this post, I share some of the challenges in patient recruitment as well as many of my key learnings in dealing with these challenges
I frequently hear from my pharmaceutical company clients that they are frustrated with the slow pace of patient recruitment for their clinical trials. Slow patient recruitment is common and can lead to lost revenues due to decreases in the period of exclusivity once a product is approved.
Additionally, recruiting patients for clinical trials is a significant expense. I’m going to share with you a few ways to increase patient recruitment and retention in clinical trials.
At its core, patient recruitment involves identifying appropriate patients and enrolling them in a clinical study. The concept sounds simple and straightforward. However, we all know that implementing patient recruitment is more complicated and time-consuming than it appears.
The primary challenges my clients face with patient recruitment are:
• Reaching appropriate patients
• Prompting patients to act and get involved in a clinical trial
• Ongoing support for patients so they stay enrolled in a trial
Additionally, there are a number of factors, including privacy policies and regulations and study design principles, that effect what pharmaceutical company sponsors can do to expedite patient enrollment. The intentions behind these factors are good and appropriate, and in order to develop alternatives we must be aware of them. So, what can be done to expedite patient recruitment?
I‘ve worked with many pharmaceutical and biotechnology companies to expedite their patient recruitment for clinical trials. From these experiences, here are a few of my key learnings:
• Outreach is key. Reach patients through traditional media channels such as print, radio, and TV advertising, as well as patient advocacy groups.
• Screening patients is critical to expedite patient recruitment and enrollment. Screening can be a bottle neck for study sites costing quite a bit of time and providing disappointing results. Develop tools or provide support to speed up screening and identification of appropriate patients.
• Support patients’ informational needs. Provide user-friendly and easy-to-understand information on study treatment and risks.
• Develop materials and tools to support patient compliance with study requirements. Patients and their family members are juggling a number of important issues during their treatment.
• Develop materials and support mechanisms that make complying with study requirements simple, easy, and automatic. Think about generating automated reminders for appointments, pre-visit instructions, and reminders to complete patient logs/diaries. Also, think about the age, demographics and preferences of the patient population. Are there common themes with patient preferences such as comfort or discomfort with electronic tools? If so, use these preferences to design patient materials and tools.
An emerging area in patient recruitment is using social media tools to identify potential study volunteers. Social media sites such as Inspire, Patients Like Me, and Army of Women all provide access to their network and followers. While social media can quickly raise awareness of a study with a specific patient population, there are unanswered questions about the potential impact of recruiting patients in this manner. Specific areas of concern are patient privacy and whether discussing the study and side effects from the treatment arms could harm the integrity of the study. At the heart of this question is whether it is possible for patients to figure which arm of the study they are on, and essentially “un-blind” the study. These are important issues to be discussed, and I’d like to hear your thoughts and experiences on using social media tools for patient recruitment.
What have you done to expedite patient screening and enrollment in clinical trials? Please share your best practices and areas to watch for when implementing these activities.
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For additional information, please visit the PhoneScreen patient recruitment page on our website.
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