How past approvals (and failures) can shape future trial success

One of the most common questions I hear from clients preparing for Phase 3 is: how do we design a trial that regulators and payers will accept as the basis for real-world adoption? It sounds straightforward, but the reality is complex. Trials can fail not because the therapy itself is ineffective, but because the endpoints are misaligned with expectations, the comparator is poorly chosen, or the competitive field has shifted underneath them.

What gives teams confidence in these moments is not just good science, but foresight. That foresight often comes from looking carefully at what has worked before, and just as importantly, what has not.

Why precedent matters

In regulatory and HTA intelligence, precedent is more than a history lesson. It is one of the most reliable signals for future decision-making. If recent approvals in an indication have favored progression-free survival as a primary endpoint, or if HTA bodies have consistently pushed back on marginal overall survival gains, that tells us something powerful about the evidence bar.

Too often, trial design teams operate in isolation from these patterns. Clinical leads define endpoints based on scientific rationale, while market access colleagues worry later about whether payers will agree. The result is a misalignment that costs time, money, and credibility.

What I advocate is an integrated approach from the very beginning: let the lessons of past approvals and failures guide the design choices that shape the future.

A client example

We recently worked with an oncology company preparing for Phase 3. They had a promising asset but limited experience in this specific indication. Their central concern was how to define a trial that would stand up not only to regulatory scrutiny, but also to the far more variable lens of payer assessment.

Our first step was to appraise the full landscape: treatment guidelines, clinical expectations, and competitor activity. Then we went deeper, mapping the drivers behind recent approvals and HTA outcomes. By tracing why certain trials had succeeded or failed, we identified patterns that carried immediate relevance for our client.

For instance, approvals in the space showed clear favor toward trials that used specific comparators aligned with guidelines, and HTA bodies consistently rewarded designs that built in diversity of patient population. These are not small details, they can make or break the value story once a therapy reaches assessment.

From intelligence to strategy

The intelligence we gathered was not just presented as a list of observations. It was structured into actionable recommendations:

• Relevant comparators backed by guideline alignment, so that trial results would resonate with both regulators and HTA bodies.
• Endpoints with precedent support, ensuring the trial would meet the expectations of decision makers.
• A competitor map highlighting where the asset could credibly differentiate itself, preventing duplication of effort.

The client gained more than a trial design. They gained conviction. With clear evidence of how past decisions shaped the present landscape, they could articulate a strategy that balanced scientific ambition with regulatory and commercial logic.

Building adaptability into the process

One of the lessons I have learned in my own career is that trial design should not be a static decision. Landscapes evolve quickly. That is why we transformed our findings into a living knowledge base, updated in real time with new competitor activity and regulatory outcomes. This ensures our client does not need to restart their intelligence-gathering every six months. Instead, they have a dynamic compass to guide them as the trial progresses.

A broader lesson for pharma

For regulatory and market access leaders, the message here is clear. If you want to maximize the chances of approval and adoption, do not wait until Phase 3 is underway to ask whether the trial aligns with precedent. Learn from the successes and missteps of others before you, and let that shape your design choices early.

At VISFO, this is exactly how we approach strategic intelligence. By combining regulatory insight, payer precedent, and competitive mapping, we help clients design trials with the finish line in mind, not just the first patient enrolled.

Because in the end, success is not just about getting a therapy approved. It is about creating the evidence base that convinces payers, clinicians, and patients that it deserves to become the new standard of care.

Click here to read the full success story.