Consensus programmes define shared expert opinion, focused around a specific unmet need. It is a highly effective and robust way of generating shared medical consensus, via a steering committee and extended faculty, without any individual opinion becoming dominant. The practical outputs provide guidance on addressing the issues around that need, which in turn informs clinical practice.

Why do I need a consensus programme?
Why might a pharma company run a consensus programme to explore a particular topic, rather than working with a society or doing a trial? It’s often down to what they actually need to address.

Usually driven by the medical affairs teams, this may be when:

* There is an urgency to provide robust guidance, for example how COVID-19 impacts a chronic condition or its treatment. They need to address an issue for which a clinical trial may take too long before providing the desired solution. There may be an evidence base or collective opinion of experts that address the questions in the short term, thus a consensus programme provides the necessary clarity.

* There are gaps or ambiguity within the product’s label and how it’s inconsistently being interpreted in clinical practice. Therefore, it is beneficial to get a group of experts to address how best to approach the item(s) in question.

* There is a topic (or unmet need) that isn't being addressed by the medical societies or competitors.

Different types of consensus programmes
It’s important to recognise that consensus is not a quick process where you develop questions, draft answers, vote and conclude. A typical consensus programme can take between 9-12 months to reach fruition.

We tend to view consensus programmes from the funding perspective. These are:

* Unrestricted grant approach consensus (single or multi pharma-sponsored programmes via a grant application)

* Hybrid consensus (usually a single pharma-sponsored programme led by the medical affairs team).

With the unrestricted grant approach, the consensus steering committee (made up of a core group of healthcare professionals) applies for a grant to a pharma company or to a group of pharma companies where they can tackle or address a specific issue. This is 100% hands-off with ‘zero’ involvement, including no ‘courtesy’ review from the sponsoring company/companies.

The hybrid consensus may allow the client's courtesy review at agreed stages of the programme but still applies a hands-off approach. In this instance, the underlying issue may have been uncovered via prior ad boards and meetings, led by the pharma company. They may later commission a medical communications agency to bring that consensus programme to life and drive it independently with the steering committee and extended faculty – leading to a publication and more in-practice guidance.

Through clarity comes confidence
The impact a consensus programme creates is driven by the clarity it provides on how to manage conditions. The sole aim of the programme is to generate the expert-led recommendations, or statements to answer the unmet need. It’s the dissemination of these final statements/recommendations that ensures the impact of a consensus programme and the usual first route of dissemination is peer-reviewed manuscripts, supported by abstracts and posters. But maximising impact comes from getting the outputs to the widest possible audience as part of a dissemination plan: symposia discussion points, MSL materials, e-learning content, representative videos… the options are endless.

We also want to compel action. To ensure the output of the consensus programme improves patient care, we may need to develop appropriate practical tools to drive effective implementation, such as monitoring checklists and interactive clinical case studies.

How to measure impact
The ROI of a consensus programme is almost instantaneous when you have meaningful discussions of the outputs with the target audience. From a quant standpoint, we look at the target audience and where they may encounter the outputs to work out approximate ‘opportunities to see’. This will help us maximise the number of views/interactions we hope to attain through, for example, journal views, symposia audiences and MSL visibility, before following up with more qual evaluation.

Consensus best practice
Consensus programmes are a core part of the Bedrock offering and we believe that they work best when being managed with a flexible, agile and thorough approach which inspires confidence in the pharma company and steering committee. You can’t predict the type and size of hurdles each consensus programme may encounter, so being very clear on the objective, approach and methodology is key. Best practice also dictates having a clear, tried and tested process that ensures all parties truly understand R&Rs, approach and proposed methodology before engaging with other stakeholders.

Derek Annan is Head of Strategy at Bedrock

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