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A good real-world evidence medical plan can make or break the development and adoption of new medicines.
A novel group awareness and consensus method (Jandhyala 2020) is used to develop the medical plan.
This engages all the internal stakeholders relevant to the commercialisation of a medicine ensuring all external stakeholders’ needs are recognised and accommodated in the development of the critical success factors and aspirational statements.
At Medialis, we use the Jandhyala method to answer list-generating questions, especially those that enhance the accuracy of measures used to observe constructs in clinical studies and trials.
This method of observing proportional group awareness and consensus consists of two rounds of questionnaires. The first survey consists of an open-ended question for the experts to answer. Answers can be used to generate an item list and assess the awareness of the experts of a particular subject; it also allows the awareness of items to be recorded in an unprompted way. The structured questionnaire generated from the items identified during the first round can also have items added to it by the investigator(s).
As such, the process of observing proportional group awareness and consensus is flexible, allowing the input of results from literature searches into the structured questionnaire in Round 2, thus providing the participants the benefit of reviewing items that may not have been suggested in their first round.
By improving the accuracy of construct measurement in clinical studies and aligning patient registry indicators with regulator needs, we help pharmaceutical companies provide regulators with vital information to enhance decision-making and ensure that the right patients are indicated for treatment at the right stage of their disease.
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