Leveraging Expert Consensus to Complement Clinical Trial Data

Leveraging Expert Consensus to Complement Clinical Trial Data

The integration of clinical trial data into clinical practice is essential for optimizing patient outcomes. However, clinical decision-making often demands greater nuance than protocols from clinical trials can provide, especially in heterogeneous patient populations or when guidelines lack specificity. Structured consensus-led methodologies can then offer a rigorous and collaborative mean of contextualizing data and guiding implementation in practice.

This article presents how the Delphi method was applied to help improve the management of metastatic hormone-sensitive prostate cancer (mHSPC) in the United Kingdom. The case illustrates the utility of expert opinion in interpreting evidence, especially when direct comparative trials are absent or incomplete.

Advancing treatment in mHSPC and clinical trial results

Prostate cancer with synchronous (metastases present at diagnosis) or metachronous (metastases developing after initial diagnosis) spread remains a significant contributor to cancer-related morbidity in men. Clinical stratification typically considers disease volume (high vs. low), timing of metastasis (synchronous vs. metachronous), patient performance status, and biomarker profiles.

Therapeutic strategies have advanced significantly, with triplet therapy (ADT + docetaxel + ARTA) showing superior overall survival (OS) in clinical trials such as PEACE-1 and ARASENS compared to doublet regimens.

Despite this, clinical uncertainty persists regarding optimal patient selection for triplet therapy, given concerns over toxicity, treatment sequencing, and generalizability. Notably, while NICE and EAU guidelines support intensified treatment, they do not clearly delineate patient selection criteria or address practical implementation issues in routine care.

The Delphi Method to bridge the evidence-practice divide

The Delphi method is a structured consensus technique designed to collect and distill the informed judgments of experts through iterative rounds of surveys with controlled feedback. Key features include anonymity to reduce bias, iterative feedback to refine opinions, and defined consensus thresholds.

The Delphi method has proven effective for helping:

• Improve clinical pathways
• Prioritise therapeutic options
• Establish treatment suitability criteria
• Align on best practices

Case Study: Delphi Consensus on Triplet Therapy for mHSPC

Summary of Delphi study

A study was conducted in the UK to establish a multidisciplinary expert consensus on the clinical utility of ADT + DOCE + ARTA for mHSPC patients, in light of emerging clinical trial data but absent direct comparative trials with doublet regimens.

The Delphi method helped generate expert opinion evidence to offer practical guidance. A diverse panel of 120 HCPs including oncologists, urologists, geriatricians, pharmacists, and oncology nurse specialists took part in the study to reach agreement on a set of statements on the following topics:

• 1. Role of treatment intensification
  2. Patient selection for triplet therapy
  3. Shared decision-making and education
  4. Multidisciplinary collaboration

Consensus was reached for 37 out of 39 statements (95%), with 27 statements achieving ≥90% agreement.

The results of the Delphi study allowed a steering group to form recommendations on:

• Support for Triplet Therapy: High levels of agreement on the clinical value of ADT + DOCE + ARTA for some mHSPC patients, particularly those with high-volume, synchronous disease
• Patient Stratification: Agreement that selection should consider age, comorbidities, metastatic burden, performance status, and patient preferences
• Barriers: Regional variations (e.g., lower agreement in Scotland, potentially due to later reimbursement timelines) and uncertainty about real-world toxicity
• MDT Role: Strong endorsement of shared decision-making and multidisciplinary alignment in treatment selection

Outcomes of the study

By incorporating real-world clinical insights, the study – published in the BMJ –  offers actionable guidance for applying emerging evidence in routine practice, supporting:

Clinical Guidance: The consensus offers clear criteria for selecting patients suitable for triplet therapy, taking into account disease characteristics, comorbidities, age, and patient preferences. This enables more tailored and patient-centred treatment decisions.

Policy Alignment: Consensus statements help interpret broad recommendations from NICE and EAU, translating them into more specific, MDT-level decisions. This supports consistent application of national guidelines across clinical settings.

Multidisciplinary Education: Findings emphasize the value of interdisciplinary collaboration and shared decision-making. These insights can inform clinical training and support unified approaches across oncology care teams.

Adaptive Implementation: The guidance supports flexible implementation tailored to regional and institutional differences in resources and infrastructure, promoting equitable access to optimized prostate cancer care.

This case exemplifies how the Delphi method can serve as a translational tool in precision oncology. It highlights the value of structured consensus in updating treatment paradigms in fast-evolving fields like oncology, where emerging evidence may outpace traditional guideline cycles for instance. In contexts where clinical trial evidence is robust yet implementation uncertain, structured expert consensus offers a way to synthesize real-world insights into actionable clinical frameworks to help achieve the intended change in patient care.

At Triducive, we generate consensus-led evidence that gets published and supports change. With deep experience across therapy areas and healthcare systems, we support clients through every step, from study design to publication, and beyond.

Get in touch with us to learn more.