I received a lot of positive feedback about my blog titled, ‘Planning a consensus-based publication? Do’s and don’ts.’ Those who haven’t read it, can access it here https://medicomindspro.com/2023/12/28/planning-a-consensus-based-publication-dos-and-donts/

Hence, I thought of this follow-up edition to explain the step-wise approach toward planning an advisory board meeting to arrive at consensus recommendations around a topic. Please note that this is specific to pharma and medical devices and might/might not apply to other fields. So, let’s begin.

Step 1 – Identifying the topic around which a consensus should be developed

Needless to say, this is the first step and should be decided by marketing and medical affairs jointly. Of course, consulting key KOLs with whom the team shares a good rapport makes the process robust. This should be easy if the team has ears to the ground and has been going on the field regularly. Yet, as mentioned in my earlier edition, things often go wrong at this step. I would strongly recommend reading the first bullet point of my earlier edition, the link to which I have shared above.

Step 2- Constituting the expert panel and appointing a chairperson from within the panel. I would presume I do not need to elaborate much on this step as it depends much on the organization’s relationships with the KOLs. Yet, there should be an attempt to have as many A+ and A class of KOLs as possible. The ideal panel size should be between 12 and 20. There are no hard and fast rules around the panel size but a very large panel makes it difficult to operationalize the entire process.

Step 3- It is good practice to have one virtual meeting with the panel before the work begins, to explain the process to them and what is expected of them.

Step 4 – Creating the statements for voting. This is the most crucial step and the onus on getting it right is with medical affairs. A list of not more than 15 to 20 statements should be created that will be put up for voting by the panel. It is important to go through the latest literature in great detail, including the guidelines, and issues around which a debate persists globally and there is no consensus or clear guidelines. I would list statements related to issues where there is a lack of clarity. It would not interest the journal or the readers to publish or read consensus recommendations mainly comprising statements where there is uniformity among all guidelines, unless the KOLs of your panel think they would like to recommend something different from the guidelines. The objective of consensus recommendations should be to influence clinical practice and guide clinicians to tackle specific situations in practice. For drafting the statements, it is helpful to write the document like a manuscript. Each statement should have a paragraph or more dedicated to it. Write the statement as the title of the paragraph and add the findings from the literature in the paragraph. At the end should be a list of all references. This document should be read and re-read by the marketing and medical affairs teams to ensure it is perfect. Another document should list the strength of evidence for each statement and votes should be sought for the strength of evidence as well to make the manuscript more robust with a higher likelihood of publication.

Step 5- The above document along with all references should be sent to each member of the panel. They should be allowed a time of 4 to 6 weeks to go through the material if you really intend to achieve a good outcome.

Step 6- Putting up the statements and strength of evidence for voting. These days some platforms manage this entire process for you end-to-end. They will put up the statements for voting, send reminder emails to the panelists asking them to vote, and also compile the results. Once the votes are closed, the members can see the results and also have a peer-to-peer discussion through chat and all of this gets captured. This can be of great use for the manuscript as well as the company’s medico-marketing strategies. Having said that, these platforms charge a high fee. Hence, tools like Google Forms continue to be used and all the compilation needs to be done by someone manually. Of course, there can be no peer-to-peer discussion through such tools.

Step 7- The advisory board meeting. The objective of the meeting is not only to share the results of the voting but also to have a discussion in favor of and against the statements and the strength of the evidence. The meeting usually focuses on statements on which no consensus was achieved. However, statements on which consensus was achieved can also be discussed. There needs to be a plan about which panelist will present in favor of/against each statement on which no consensus was reached. Each presentation should be followed by an open discussion and the statements should be put up for voting again. Having a discussion on statements that have achieved consensus in the online voting can be optional.

These steps in essence sum up the process of consensus after the manuscript planning process begins. As you can see, the process of achieving consensus recommendations is laborious and lasts over some months. The reason for most consensus-based publications being rejected by leading journals or not the publications not making much of a clinical impact is that the process is not followed or tweaked to bypass some crucial steps. I hope this article will help you plan better for such projects.