Unpacking Screen Fail Payments in Research

05/31/25 • 11 min

In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic.

From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that paying for every screen fail, without oversight, opens the door to unlimited financial exposure—and more dangerously, potential kickback violations. They emphasize the need for fair market value, capped budgets, and data-driven estimates of expected screen failure rates.

From the site’s perspective, there’s agreement: not all screen fails are avoidable, especially when a patient appears eligible but fails due to factors like lab results or genetic markers. Sites aren't asking for a blank check—they're asking for reasonable compensation when they've performed due diligence.

Together, we explore:

Why defining a “well-intentioned” screen fail matters.
How scientific and protocol-driven caps can align sponsor and site expectations.
The role of legal and clinical experts in designing fair, compliant agreements.
The compliance risks, especially under increased federal scrutiny in healthcare fraud.
Why sites must talk to their PIs and be empowered to negotiate using data—not just accept arbitrary screen fail caps.

Ultimately, this episode calls for collaboration, transparency, and data-backed contract terms. By using available science and engaging clinical and legal expertise, sponsors and sites can protect patients, stay compliant, and build long-term trust.

Support the show

Together, we explore:

Why defining a “well-intentioned” screen fail matters.
How scientific and protocol-driven caps can align sponsor and site expectations.
The role of legal and clinical experts in designing fair, compliant agreements.
The compliance risks, especially under increased federal scrutiny in healthcare fraud.
Why sites must talk to their PIs and be empowered to negotiate using data—not just accept arbitrary screen fail caps.

Support the show

Previous Episode

Post-Trump Antitrust Rules Are Crushing Pharma Deals

In this episode, we explore a crucial and timely issue: how the Trump administration’s approach to antitrust enforcement—combined with new state-level regulations—is creating a shifting legal environment for life sciences companies, especially those involved in mergers and acquisitions (M&A).

At the federal level, Assistant Attorney General Gail Slater, in her first major antitrust address, emphasized a renewed focus on strict legal enforcement. Rather than relying on expansive regulatory interpretations, the administration is doubling down on clear statutory authority. This signals a return to more traditional antitrust principles, with heightened scrutiny of M&A transactions that may limit competition or consolidate market power.

But the complexity doesn’t stop there.

On April 4, 2025, Washington State passed SB 5122, becoming the first state to mandate broad pre-merger notifications across all industries. Effective July 27, 2025, this law requires companies meeting specific criteria—such as having a Washington-based headquarters, generating over $25.3 million in state sales, and operating as a healthcare provider or organization—to submit their federal Hart-Scott-Rodino (HSR) filings to the state Attorney General’s Office. Although there’s no filing fee or mandatory waiting period, noncompliance can lead to civil penalties of up to $10,000 per day.

This development sets a precedent, and other states like New York and California are already considering similar requirements. Life sciences companies must now navigate a growing web of both federal and state-level antitrust obligations.

Key Implications for Life Sciences Companies:

More aggressive M&A oversight: Federal and state authorities are signaling stricter reviews, particularly in transactions involving healthcare players.
Multi-jurisdictional compliance risks: Companies operating across several states must track and comply with differing notification and filing obligations.
Operational readiness is essential: Internal legal and compliance teams need to coordinate more closely with business development to ensure smooth and compliant deal execution.

Strategic Recommendations:

Antitrust Risk Assessments: Evaluate all proposed and ongoing transactions for potential red flags at both state and federal levels.
Monitor Legislative Trends: Keep track of proposed laws in states like Massachusetts, California, and New York that may soon mirror Washington’s model.
Strengthen Internal Protocols: Develop systems to ensure accurate, timely submissions of required documentation—both federally and at the state level.
Engage Counsel Early: Legal teams should be involved at the earliest stages of deal structuring to identify issues before they escalate.

In an environment where both federal enforcers and state regulators are increasing scrutiny, proactive planning is critical. Companies that adapt quickly to these shifting expectations will be better positioned to manage risk and maintain momentum.

Stay tuned for our next episode as we continue exploring the legal and regulatory trends shaping the pharmaceutical and life sciences industries.

Support the show

Next Episode

Pharma Ads Are Getting Canceled

Google’s 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google blocked over 5.1 billion ads last year and restricted 9.1 billion more. Healthcare ads were hit especially hard, with over 106 million healthcare and medicine ads being blocked. If you’re still relying on old review systems or outdated playbooks, you’re in trouble—Google’s new AI can spot violations at lightning speed, often before you even see it. Ads can be blocked mid-upload, campaigns can collapse without warning, and Google now judges not just the content but your business practices—anything from a bad landing page to an imperfect payment system could lead to a suspension.

The report also revealed that in 2024 alone, Google suspended a staggering 39.2 million advertiser accounts, with identity verification now mandatory for over 90% of live ads. The stakes are higher than ever: if your ad has even the smallest imperfection, like a misleading claim or missing disclosure, Google’s AI will find it—and it will act fast. To survive in this new environment, pharma and device marketers must adapt immediately.

Here’s what you must do to stay in the game:

Rebuild your review process – Think like Google’s AI. Test every ad for potential violations and ensure no ad slips through without rigorous scrutiny.
Avoid vague or risky language – No more overpromising or claims without solid regulatory backup. Be literal, clear, and backed by evidence.
Expect ad rejections – Budget for 10-20% fallout rate and build in time for appeals.
Have backup campaigns – Don’t rely solely on Google. Build redundancy across other platforms like Meta, LinkedIn, and even TV.

The new era of AI enforcement demands precision, compliance, and a willingness to play it safe. If you fail to evolve, you’ll risk public failure, budget losses, and potentially losing your market position. Adapt now or be left behind in this AI-driven world.

Support the show