Delphi Studies and Other Consensus-Building Studies
A Delphi study is a methodology in which expert panels are surveyed over multiple rounds to achieve convergence (consensus) of opinions. Responses are collected anonymously, and a summary of results is fed back after each round, thereby reducing bias among experts and achieving more valid consensus formation.
Features of Delphi Studies
Anonymity
Prevents the peer pressure common in face-to-face meetings, enabling the collection of purer expert judgment.
Iterative Feedback
Through an iterative process of questionnaires, aggregation, anonymous feedback, and response revision over multiple rounds, opinions are gradually converged.
No Physical Meetings Required
Free from constraints of time, location, and travel. Studies are conducted using online tools.
Expert Panel
Aimed at systematically integrating expert knowledge and insights.
Value of Delphi Studies
Identifying unmet needs in clinical practice
By systematically and anonymously converging the insights of multiple experts, it is possible to objectively extract the essential challenges faced in clinical practice, rather than relying on individual voices.
Visualizing evidence gaps
Expert consensus on where data is lacking, priority of RWE/PMS/exploratory studies, and which endpoints and patient populations are appropriate is extremely important as a scientific basis for research planning.
Deepening relationships with KOLs
Because Delphi is a scientific method that minimizes bias through anonymity, multiple rounds, and quantitative evaluation, it enjoys high credibility from KOLs. This builds a strong foundation of transparency and scientific rigor in the relationship between Medical Affairs and KOLs.
Disease Areas Suited for Delphi Studies
Particularly effective in areas where medical consensus is divided or where clear guidelines do not exist.
Areas with complex treatment decisions
Areas with large evidence gaps
Areas where patient-centered assessment is important
When to Conduct Delphi Studies
Delphi and other consensus studies can be utilized across a wide range of situations from early development through post-launch.
Early Development
When disease understanding and organization of unmet needs are required: clarifying the realities and challenges of clinical practice, organizing important outcomes, prioritizing patient populations, and building a foundation for differentiation from competing treatments.
Clinical Development Phase
When validating trial design: appropriateness of primary/secondary outcomes, clinical validity of inclusion/exclusion criteria, alignment with real clinical challenges, and consensus formation on comparator settings.
Pre-Approval to Pre-Launch
When organizing the scientific positioning of the product: which patient groups will benefit most, challenges with existing treatments and use cases prioritized by experts, and organizing KOL priorities and expectations.
Post-Marketing
When leveraging for data gaps and challenges in real-world clinical practice: consensus on appropriate use, identification of priority research themes for RWE and PMS, positioning in treatment algorithms, and understanding efficacy/safety in specific subgroups.
Track Record
INTERNATIONAL JOURNAL OF HEMATOLOGY (SPRINGER)
Modified Delphi method on the use of ropeginterferon in polycythemia vera patients
Modified Delphi method
2023-2024