When conducting clinical trials, patient insights are helpful when:
- Designing a protocol
- Developing and refining patient recruitment and enrollment materials
- Developing and refining patient facing consenting materials
- Developing and refining patient retention activities
When creating patient focused clinical trials, advisory boards can be useful and have a role; however, they should NOT be your primary source of patient insights. Anonymous patient and caregiver insights add substantial value when designing protocols, and more value than advisory boards during every other phase of clinical trials. The following table summarizing the relative value of patient advisory boards and anonymous patient and caregiver insights by the stage of clinical trial design and planning.
|Patient Advisory Board||Anonymous Patient & Caregiver Guidance|
|Patient Recruitment & Enrollment Materials2||+3||++++4|
|Patient Facing Consenting Materials2||+3||++++4|
|Patient Retention Programs2||++3||++++4|
1. When designing protocols, both patient advisory boards and anonymous patient and caregiver insights are helpful. An advantage of advisory boards is that participating patients have the time and commitment to conduct an in-depth review of the protocol. They provide detailed feedback on numerous aspects of the protocol design, making it more patient-friendly.
There are two things to avoid when conducting patient advisory boards: First, do not allow one or two patients to dominate the conversation. Managing discussions during advisory board meetings is a skill and should not be assigned to a project team member. Second, be aware of patients on an advisory board whose allegiance shifts from ensuring patient needs are being addressed to making project teams happy.
2. When designing protocols, there is enormous value in eliciting feedback from patients (and caregivers) who participated in your earlier clinical trials. For example, as you prepare for Phase 3 trials, obtain input from study subjects from your Phase 2 trials. They can tell you what was easy and what was difficult. They can tell you what was rewarding and what was a hassle.
3. When evaluating patient recruitment and enrollment materials, patient facing consenting materials or patient retention programs, patient advisory boards are NOT the appropriate venue. Except for trials in ultra-rare diseases, communication materials such as those for patient recruitment, consenting, and programs for patient retention should be evaluated by a broader audience. Communication materials should NOT be based on a consensus – they should be easily understood, compelling, and relevant, providing a clear call to action to a wide range of your target audiences.
4. Anonymous patient and caregiver guidance are very effective for evaluating and refining patient recruitment and enrollment materials, patient facing consenting materials and patient retention programs. Internet-based conferencing capabilities allow patients to view and even revise materials during telephone-internet interviews.
In summary, using the right source of patient feedback at each step of your clinical trial will ensure it has the greatest chance of success.
To learn more about how I can help you at each stage, please contact me at 610-256-5623, or email me at firstname.lastname@example.org.