How to Optimize Clinical Research with Patient Advisory Boards

What is a Patient Advisory Board (PAB)?

A PAB is a panel of 5–8 patient experts who provide first-hand insight to inform and enrich product development. A PAB is a comprehensive, transversal tool that can address many lifecycle challenges at once. When it comes to clinical research, a PAB can help sponsors with accurate and strategic planning, co-development of a device or digital therapeutic, evaluating real-life feasibility of clinical protocols, confirming trial end points, developing the Target Product Profile (TPP), and testing the comprehensiveness of Patient Reported Outcomes (PROs).

PABs provide many important insights that often require analysis by the sponsor to effectively incorporate the actionable information into the overall project, and including patients early brings the most long-term value to clinical development. This gives the sponsor the most opportunity to translate these outcomes into clinical protocols that satisfy both business requirements while meeting the real unmet needs of the patient.

Why is a PAB important to clinical research?

Done correctly, a patient advisory board improves speed to market, helps avoid costly mistakes and protocol amendments, and improves overall return on investment (ROI). And, particularly with rare diseases, input from patients is key to market success. Rare disease patients have often had to create a patient journey for themselves—they are experts in disease management, pathology, potential solutions, and clinical trials—and how these impact their real-life needs.

And for sponsors, a PAB is more relevant for rare diseases because the unmet need is so high, and the patient population is so small. The opportunity to get direct patient input to inform planning, clinical trial design, recruitment, and execution, as well as PROs and treatment protocols, is an essential part of successful product development. PROs developed in collaboration with patients are always stronger than those developed without direct patient input.

How to create a successful PAB for clinical research

1. Engage early

The sooner you set up a PAB for your product, the better. Typically, PABs are included as part of Phase II or as early as Phase I for areas like oncology, where you want to have patients inform protocols as early as possible. You can use a PAB to help develop or validate PROs, so any early work or planning that is labor intensive can benefit from including patients.

Including patient input before clinical trial design also ensures that your design is feasible in all areas: recruitment, protocol, and endpoints. For example, talking to patients before you design the trial can inform impacts like Quality of Life (QoL) and everyday care. Patients will have insights that are tied to things like adherence and dropout rate including “non-clinical” factors like distance to trial and number of required visits.

Creating trials that are feasible for patients to participate in result in faster recruitment, lower dropout, and fewer protocol amendments—all elements that directly impact the budget and timing of clinical trial and research outcomes.

2. Find the right patients

Recruitment process for creating PAB is key and must be approached with clear inclusion and exclusion criteria. Ideally, you would have balanced recruiting through patient organizations and physicians, so you get a variety of patient profiles. Patients recruited through patient organizations are very empowered and educated on their disease, and you want to balance the patients to get a more full, accurate picture of the larger patient population.

Recruitment for a PAB can also take time—you want to find the right patients who can meet the expectations of the advisory board. While recruitment may take as little as one month, two months is a more reasonable expectation for the PAB recruitment process.

Once you find the right patients, focusing on compliance, confidentiality, and compensation is key. Patients need to be compensated fairly for their work with you—typically three or four hours, plus any pre-meeting material review. Research what the fair market value is for PAB compensation and align with any regional rules for compensation. Typically, the average PAB compensation is around $100/hour in the United States and 70€ in Europe.

3. Choose the right partner

While some sponsors may choose to run their own PABs, there are several advantages to connecting with outside experts to help you structure, recruit, and execute your PAB. Perhaps the most important element is that a partner organization will work closely with you to set up the criteria for patients and help you organize the PAB, but then provide the most unbiased information and results from the group. Additionally, if you use a partner organization, the PAB is completely blind—the patients will not know who the sponsor is.

The right partner can also deliver an effective structure for your PAB—the moderation guide. This guide, along with an emphasis on using plain language—are key to successful PABs. Patients have so much to share that having a detailed structure to guide the conversation and collect the relevant info is key to a balanced meeting. Most PABs are three hours, so strong facilitation is essential to allow the patients to feel heard while meeting the business goals and objectives of the panel.

4. Integrate the feedback

Once you receive the results of your PAB, incorporating the feedback may be the most challenging aspect. Determining which insights can be implemented immediately allows you to manage and make informed decisions. Protocols, study designs, and outcome measures may already be in progress, but PAB feedback that isn’t actionable for the current clinical phase you’re in can be used to inform the strategy and execution of future phases.