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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I'd also love to hear how social media tools are being used for patient recruitment as well as throughout a trial.
ReplyDeletePatient recruitment is definitely a challenge and your insights are right on as to the many considerations necessary to creating a good recruitment and retention architecture. Thanks much!
ReplyDeleteDan, our world is shifting rapidly from recruitment to engagement; It is cheaper to engage patients than it is to recruit them and social media is playing a critical role. Companies are figuring out that once having invested in recruitment for a study, it is cost effective to engage patients and sustain their interest for another one in the same therapeutic area or for a follow-on study. It’s shifting the paradigm from static aging databases to JIT (Just in time)databases and forums, where trust and relationships are established with patients and this is essential for recruitment success. There are numerous examples of where this is occurring in the industry. We actively manage over 20 such patient communities using social media. Rather than keep investing in recruitment campaigns, only to re-invest again to find the same patient population, our BioPharm clients support engaging patients as a way to accelerate enrollment. Success in engaging patients is predicated on patient-centric thinking, transparency of purpose-letting patients know the purpose and mission of the community (clinical trials for example), and knowing what it takes to keep patints coming back again and again. We keep our patient communities 'sticky'. Just in one patient community aloneto promote clinical research for a specific medical condition we have topped 40,000 patients!
ReplyDelete@Liz, Great comments. I agree, engagement > recruitment.
ReplyDelete