In the biopharmaceutical industry, phases of innovation and change are often driven by regulatory action. The Office of the Inspector General’s (OIG) 2020 special fraud alert, focused on speaker programs, explicitly states that the OIG is “skeptical about the educational value of such programs.”
Formal, written needs assessments should be a foundational exercise for speaker bureaus, just as they are for medical education and continuing medical education. Speaker Bureau Compliance Director Jenny Murphy at Woven Health Collective notes, “A needs assessment is an ever-important first step to ensure program compliance, and it can serve as a useful road map to help teams simplify communication, effectively implement and execute programs, track adherence, and guide future program development. Furthermore, it is a best practice to review and reassess annually.”
Here are four essential considerations for Speaker Bureau and how they can simplify compliance:
“Last year’s topic, with a twist” does not cut it for speaker program content. Assessing and documenting the need to educate HCPs who treat the patient population you serve is the foundation on which a speaker bureau needs assessments should be built.
A collaborative approach to defining the educational need works best. Combine the expertise of compliance professionals, scientific staff, data analysts, operations management, and a learning design team to create thoughtful rationales for each speaker bureau. The following are a few questions to ask:
There’s no escaping it. Everyone consumes information and learns in quite different ways than in previous times, including HCPs. The OIG recognizes this, noting, “HCPs can access the same or similar information provided in a speaker program using various online resources, the product’s package insert, third-party educational conferences, medical journals, and more.”
We understand that reading a package insert, while informative and important, may not necessarily be an engaging or complete educational experience. When addressing important issues of patient care, both the didactic and human elements of the content are important.
Decisions about learning format (eg, in-person, live, virtual, on-demand, asynchronous) are deeply connected to educational effectiveness. For example, content is easier to defend when the educational design specifically encourages or requires faculty and attendee interaction and engagement.
“Thoughtful curriculum design better engages audiences, fosters collaboration and learning, and supports the continued need for in-person education.”
Jenny Murphy
Woven Speaker Bureau Compliance Director
Being creative with curriculum design and using modern, validated teaching techniques help establish the need for specific learning formats. “Thoughtful curriculum design better engages audiences, fosters collaboration and learning, and supports the continued need for in-person education,” Jenny said.
The selection of program faculty is another area of intense scrutiny. The OIG states a “suspect characteristic” of a speaker bureau is when a “company’s sales or marketing business units influence the selection of speakers” for the bureau.
As a result, it’s critical to establish clear guidelines for speaker selection separate from commercial interests. Today, artificial intelligence and data science techniques simplify this. Christy King, head of Data Science at Woven notes, “Speaker selection used to rely on very few variables. Today, we have access to a wealth of data and smart algorithms that can help companies paint a multidimensional picture of potential speakers that’s objective, compliant, and highly effective.”
Implementing a systematic, technology-driven nomination process is a best practice. Woven, for example, developed an automated Speaker Nomination tool for our cloud-based engagement platform, CMGO. According to Shirin Masica, Woven's Director of Speaker Bureau Management, “Speaker nomination can be a very labor-intensive, time-consuming process. The automation that CMGO provides really takes a burden off our clients and offers a careful record of compliance criteria and approvals.”
Tracking and documenting program compliance, especially across multiple products or franchises, has traditionally been a spreadsheet-fueled challenge. Part of a program plan must include how data are collected, reviewed, stored, and available for audit. Fortunately, speaker bureau management technology has evolved rapidly. Newer systems, such as CMGO, have transformed speaker bureau technology from a loose collection of siloed systems into one system with powerful automated compliance and reporting tools built right in to manage everything from compliant venue selection and attendee data across an organization to speaker nomination, contracting, training, and utilization.
First published November 21, 2023