By Anna Rose Welch, Director, Cell & Gene Collaborative
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As pharma strives to make clinical trials and drug development more patient-centric, current clinical trial recruitment protocols leave much to be desired in terms of boosting patient engagement. Clinical Leader turned to several recruitment experts to get a better picture of what sponsors should consider when recruiting clinical trial participants, especially as patients demand more of a voice in their treatment protocols and clinical trials become increasingly regulated and expensive undertakings.
AR Welch: What roadblocks (internal or external) are keeping pharma from succeeding at patient engagement, and how could these barriers be removed?
For the sake of clarity, we are defining patient engagement as all interactions between sponsors or sites and patients. The interactions occur during study planning, during data mining and feasibility activities, and throughout awareness and recruitment campaigns, screening processes, study conduct, and study follow-up and closeout activities. Patients are generally screened for one protocol, however, screening across several protocols could accelerate matching and also increase subjects’ willingness to participate by providing them with study options that clearly identify risk/benefit and burden. Non-evidence-based recruitment feasibility outcomes should no longer be used as a stand-alone predictor of recruitment timelines. Additionally, sponsor liaisons trained in the targeted diseases can help build patient communities, which could enable interested patients to be entered in a database that allows sites to easily contact them about upcoming studies. Finally, patients are not thanked enough for taking time to participate in studies. Sending a simple thank you to patients and caregivers shows appreciation, encourages patients to spread the word to others, and promotes goodwill. — Kurt Mussina, VP and general manager, Frenova Renal Research
Although outreach and engagement through patient advocacy groups have been very successful, these efforts have been largely focused on underserved patients or unmet medical needs. To broaden engagement, we need to acknowledge that investigator sites have become the primary intermediary between the sponsor or CRO and the patient. Going forward, the industry will need to shift its thinking in such a way that addresses HIPAA and patient privacy issues in order to adjust to the increasing importance of investigator sites. — Marc Hoffman, MD, CMO, Theorem
There is still a lot of room for improvement in the ways industry leverages technology to identify, engage, and interact with the individuals who might look to participate in research. Recruitment and retention support programs are regularly conducted that employ the use of powerful and highly targeted mechanisms for patient identification, including the use of sophisticated insurance claims and electronic medical record databases, study specific websites with highly targeted search engine optimization and pay-per click advertising mechanisms, smart phone applications, text message appointment reminders, and more. Still, too many sponsors turn down these approaches in favor of more traditional, passive, and less targeted approaches. Thankfully, there are a number of initiatives being employed to make the patient more of a partner in the drug development process — for example, conducting regular patient-focused market research surveys to better understand the patient perspective when it comes to participation in clinical trials. — Dan McDonald, director, business development, DAC Patient Recruitment Services
In the pre-enrollment stage, sponsors can gain tremendous insight into protocol and study design from people who have the targeted disease and are interested in trial participation through quantitative surveys and qualitative interviews. These research tools should pose specific questions about disease comorbidities that might be exclusionary, patient perceptions about the study visit schedule, procedures performed, and time commitment, and other probing questions that provide enhanced transparency for potential patient engagement challenges. These insights help ensure that a clinical trial has been appropriately vetted by the intended trial audience and optimize patient feedback before study launch. Even if the protocol design cannot be changed, the engagement exercise will help the sponsor understand how easy or difficult enrollment will be and can help them budget accordingly. — Roger Smith, SVP, Global Clinical Operations, Acurian