Why integrate consensus studies into evidence generation strategy
Medical Affairs plays a pivotal role in shaping clinical practice through evidence generation strategy. While randomized controlled trials (RCTs), real-world evidence (RWE) and health economics data remain foundational, consensus studies are increasingly recognized for their value in addressing evidence gaps that traditional studies cannot. Integrating consensus studies into the broader evidence generation strategy provides actionable insights, enhances stakeholder engagement, and supports clinical decision-making.
This article outlines why Medical Affairs should systemically integrate consensus studies into their evidence generation strategy.
Evidence generation strategy & evidence gaps
One of the most compelling reasons to incorporate consensus studies into evidence generation strategy their ability to fill important clinical gaps that RCTs or RWE may not adequately address. Despite their scientific rigor, RCTs are inherently constrained by strict inclusion and exclusion criteria, leaving out significant patient subgroups. As a result, many real-world clinical decisions must be made in areas where there is little to no high-quality evidence available.
Consensus studies provide a structured means of accessing the collective expertise of clinicians who manage these patient populations day to day. By gathering and distilling expert opinion, these studies can establish agreed-upon diagnostic criteria, treatment algorithms, or care pathways where empirical data is either absent or contradictory. For example, this can be particularly needed in the case of rare disease or for emerging treatments.
Moreover, consensus outputs often serve as foundational evidence to inform subsequent research. By clarifying clinical uncertainty, they can highlight priorities for future clinical trials, support protocol design, or shape the selection of relevant endpoints in outcomes research. In this way, consensus studies are not only a contributor in evidence generation but also a catalyst for more targeted, patient-centred research.
Evidence generation strategy & clinical guidance
Clinical guidelines play a critical role in standardizing care, but the process of developing them is typically lengthy, often taking several years from evidence review to final publication. In fast-moving therapeutic areas such as oncology this lag can result in a disconnect between available treatments and what is formally recommended in practice. During this window of uncertainty, clinicians frequently turn to expert opinion and real-world insights to inform decisions.
Consensus studies offer a practical, scientifically grounded approach to bridge this temporal gap. When designed rigorously and transparently, they produce interim clinical guidance that is both evidence-informed and practice-oriented. This can be especially valuable during the early adoption phase of a new therapy, when HCPs seek clarity on treatment initiation thresholds, sequencing with existing treatments, or monitoring practices.
These studies are also uniquely positioned to contextualize emerging real-world evidence. While RWE is increasingly used to complement RCT data, interpreting its findings can be challenging due to variability in study design and patient populations. Consensus studies provide the clinical judgment and interpretative lens needed to make sense of real-world trends, thereby enhancing their applicability and impact in day-to-day clinical practice.
Ultimately, by producing agile, clinician-endorsed recommendations, consensus studies can accelerate the translation of evolving evidence into action, improving the timeliness and relevance of Medical Affairs’ contributions to clinical care.
Evidence generation strategy & external engagement
Consensus studies are not just about generating evidence, they also serve as powerful platforms for scientific engagement. For Medical Affairs teams, initiating and leading a consensus initiative creates structured, meaningful opportunities to collaborate with a diverse network of external experts. These relationships are essential for understanding practice-level insights, uncovering unmet needs, and testing the real-world applicability of scientific messages.
Additionally, by involving experts from different specialties and geographies, consensus studies ensure a broader perspective is captured, helping to generate outputs that are both clinically credible and globally/geographically relevant. The collaborative nature of these projects also encourages scientific ownership among participants, which can enhance the credibility and dissemination of the final outputs.
From a strategic perspective, this type of external engagement allows Medical Affairs to position itself as a facilitator of high-quality, practice-enabling science, distinct from commercial interests, yet aligned with broader organizational goals.
Evidence generation strategy & market access
While consensus studies are often viewed through a clinical lens, they are increasingly recognized for their strategic value in market access planning. In scenarios where traditional evidence is lacking, technology assessment (HTA) bodies, payers, and formulary committees can look to expert consensus to inform their evaluations.
A well-structured consensus study can offer a credible justification for the clinical appropriateness, safety, and value of a therapeutic intervention in a defined population. For example, if RCTs have not been conducted in elderly patients or in those with multiple commorbidities, but the treatment is widely used in these groups, consensus-derived guidance can validate this practice. It provides a formalized, peer-endorsed rationale that can be referenced in reimbursement dossiers or payer negotiations.
Additionally, consensus findings can be integrated into economic models as inputs, especially when quantitative data are unavailable. Expert-derived treatment pathways, utilization patterns, or definitions of treatment success can enhance the robustness of cost-effectiveness analyses and budget impact models.
Thus, from early pipeline to post-launch, consensus studies support value communication across stakeholder groups, reinforcing the scientific and clinical rationale for access and adoption.
Consensus studies are a valuable complement to traditional evidence, helping Medical Affairs fill clinical gaps, provide timely guidance, engage experts, and support market access. By integrating them into evidence generation strategy, teams can deliver practical, credible insights that inform decisions and drive meaningful change in clinical practice.
About us
At Triducive we deliver consensus-led evidence that gets published and supports change, collaborating with medical affairs and other teams in life sciences all around the world. With a strong background in healthcare, we have been delivering 130+ Delphi consensus to date, helping to change practice and guidelines, improve pathways, and support payers’ decisions.
Get in touch with us to learn about how a consensus study can help you achieve your objectives.