- David Jones
- Feb 24
- 4 min read
For clinical operations leaders, biotech sponsors, and CRO professionals, aligning study design with real-world adoption is critical for clinical trial success. Insights from COG Europe spotlight why early engagement of Key Opinion Leaders (KOLs) is central to clinical trial outsourcing, operational efficiency, and market viability.
This article draws on a keynote session from COG Europe in Amsterdam featuring Thierry Schulmann, Senior Director Medical Affairs Strategy at Sumitomo Pharma, joined by Bart Scheerder. With substantial background in clinical operations, strategy, and medical affairs, Thierry Schulmann explores both successes and setbacks in clinical study programs. The presentation, aimed at clinical operations and evidence strategy professionals, directly addresses why products fail post-approval and how to leverage KOLs to avoid common pitfalls.
The Imperative: Why Some Approved Products Never Launch
Clinical operations leaders are acutely aware: even well-executed studies don’t guarantee commercial success or routine adoption. Thierry Schulmann opens with three instructive cases where products received regulatory approval but failed to launch or gain traction in key markets. The reasons were not study design flaws per se—it was weak alignment with real market needs, payer expectations, and local clinical practice.
Key barriers cited include:
Choosing non-relevant comparators for European submissions
Developing in indications where market need and differentiation were already satisfied by generics
Designing trials focused on statistical significance over clinically meaningful endpoints (e.g., patient QoL and tolerability)
The message:
Market access, patient adoption, and regulatory fit are determined far upstream, at the intersection of study design and true unmet needs. Clinical trial outsourcing strategies must factor this from the start.
Deepening the Role of KOLs in Clinical Study Planning
Rather than seeing clinical outsourcing as simply contracting with CROs, Thierry Schulmann urges sponsors to “outsource” design thinking and validation to disease-area KOLs and leading investigators. Their value extends well beyond operational site leadership—they bridge academic expertise, regulatory trends, and the lived realities of patient care.
KOLs provide:
Strategic Protocol Input: KOLs ensure protocols align with regulatory expectations (FDA, EMA, MHRA) and anticipated payer scrutiny, selecting appropriate comparators and outcome measures relevant for each region.
Clinical Relevance Over Statistical Significance: Drawing from real patient experience, KOLs help move beyond chasing minor, statistically significant changes to identifying endpoints that truly matter—reducing events, improving quality of life, or minimizing patient burden.
Patient-Centric Perspective: Leading KOLs help ensure studies consider recruitment realities and patient burden (e.g., consent process, procedures), which are increasingly important for patient-centric trials and real-world adoption.
Clinical trial outsourcing models should integrate KOL advice as early as possible—ideally as soon as preclinical or phase 1, especially in novel therapeutic areas.
Operationalizing KOL Engagement for Clinical Study Optimization
To make clinical outsourcing strategies effective, Thierry Schulmann details practical approaches to KOL engagement:
Early & Cross-Functional Involvement: Initiate KOL dialogue early, not just for protocol sign-off, but for disease awareness, market shaping, and identifying unmet needs—even before discussing specific compounds.
Selecting KOLs with Both Academic and Practical Strengths: Recognize that some academic leaders may be less effective at patient recruitment or practical patient communication. A balanced network should include both high recruiters and thought leaders.
Multinational Insights for Global Studies: Leverage KOLs from multiple regions to avoid comparator missteps and ensure studies meet regulatory and payer expectations in each market, supporting multicentral, global clinical trials.
Therapeutic and Regulatory Guidance: KOLs with experience in crafting and interpreting guidelines help ensure that both study design and dossier submissions are “future-proofed” for evolving standards and reimbursement criteria.
Clinical operations best practices must account for the shifting landscape: regulatory, payer, and patient requirements are no longer independent silos, and KOLs uniquely navigate these intersections.
Real-World Lessons: The Cost of Misalignment
Three anonymized case studies offered by Thierry Schulmann crystallize these issues:
Choice of Comparator: A pain product, studied using a US-only comparator, was not commercialized in Europe because regulatory bodies (and clinicians) saw the data as non-representative.
Indication and Market Need: A hypertension drug (“fourth-in-class”) lacked differentiation and was priced uncompetitively—so, despite approval, the sponsor made a strategic decision not to launch in Europe.
Patient Experience & Endpoint Selection: A COPD product failed commercially because significant side effects emerged before patients realized clinical benefit; the trial also used placebo, not an active comparator, making results less persuasive for clinicians and regulators.
All three cases highlight where earlier, broader KOL engagement could have flagged market, patient, or regulatory disconnects—well before trial execution or CRO selection.
What This Means in Practice: Action Points for Clinical Teams
Engage KOLs and patient associations prior to phase 2 protocol finalization.
Validate region-specific comparators and endpoints with local/regional KOLs to ensure regulatory and clinical relevance.
Integrate quality-of-life and patient-burden measures into study endpoints—beyond statistical significance.
Balance selection of academic KOLs (influencers, guideline authors) with high-performing sites for recruitment and patient engagement.
Use KOL insights to anticipate market access and reimbursement hurdles—not just regulatory approval.
Utilize KOLs as intermediaries with patient groups when direct sponsor-patient communication is restricted.
Foster continuous KOL input through study design, execution, and market launch—not one-off consultation.
Key Takeaways
KOL involvement should begin at the earliest phase—ideally before protocol development—to align study outcomes with clinical, regulatory, and payer needs.
Protocols must be tailored to regional standards of care, with explicit validation of comparators and outcomes by local experts.
Clinical trial outsourcing models that integrate KOLs reduce the risk of post-approval market failure due to misaligned evidence or endpoints.
Patient-centric trial design—shaped by practical site and KOL input—boosts recruitment, retention, and eventual adoption.
Continuous KOL engagement across the product lifecycle supports both regulatory success and efficient market access.
Quotes
“Making a study without launching it in the market doesn’t make sense. There are scientific benefits, but at the end... we want to bring this product to the market.” – Thierry Schulmann
“The choice of comparator was not relevant for Europe. The study was beautiful, but the regulatory agencies said, ‘What do you want me to do with this? We don’t have this product.’” – Thierry Schulmann
“They are instrumental in the guideline... the companies are very much trying to push this KOL in order to include the product as much as possible in the guidelines.” – Thierry Schulmann
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