In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? And if not, how can we ethically and compliantly pay them more?

Key Takeaways:

1. The Coercion Concern
   Compensation for trial participation is often scrutinized by IRBs due to concerns around coercion. Historically, this concern stems from extreme abuses (e.g., experiments in Holocaust camps) and evolved to include more nuanced forms, such as overpromising benefits or targeting vulnerable populations. IRBs are cautious that financial incentives don’t unduly influence a participant’s decision.
   
   
2. But Patients Face Real Burdens
   Participating in a trial is often time-consuming, emotionally taxing, and logistically difficult. Compensation is not just an incentive—it's a recognition of the burden placed on participants. Yet current payments often fail to account for this.
   
   
3. A Global Recruitment Crisis
   Across all demographics and trial types, the number one reason for trial failure is lack of patient recruitment. Fair compensation could help address this issue—if it can be done without violating regulations.
   
   
4. Legal Barriers: Beyond Coercion
   Darshan brings up beneficiary inducement laws, which restrict offering anything of value to influence a person’s use of a federally reimbursable product. While originally designed for approved treatments, there’s increasing concern that these rules could be applied to clinical trial recruitment efforts as well—particularly when sponsors fund community health services or resources tied to participation.
   
   
5. Real-World Examples Highlight Complexity
   While something like giving out muffins after a visit isn’t likely to raise flags, some site networks market clinical trials in low-income communities by promising access to healthcare that’s otherwise unavailable, which could cross into inducement territory. And this practice is far more common than many realize.
   
   
6. Sponsors vs. Sites
   Sponsors may be unaware of how their budgets are used downstream by sites, but they can still be held accountable. Because sites act as pass-through entities, improper use of funds for inducement can reflect back on the sponsor.
   
   
7. Practical Path Forward: A Data-Driven Model
   Instead of assigning arbitrary amounts, the speakers suggest using data:
   
   
   • Average wage in the region
     
     
   • Cost of living
     
     
   • Lost wages due to trial participation
     
     
   • Travel and time burdens
     
     
8. A standardized but flexible model could provide equitable compensation without crossing legal or ethical lines.
   
   
9. Time for a New Standard
   The speakers argue that the current standards around coercion and compensation are outdated and inconsistent. With no clear guidance from regulators, decisions often fall to IRBs, who base them on precedent rather than science or patient-centered logic.
   
   

Conclusion:
Most would agree patients aren’t being paid enough for their participation. But increasing compensation isn't just a matter of kindness—it's a compliance challenge. The solution lies in balancing fair compensation with clear regulatory guidance. That means moving beyond fear of coercion to thoughtful, data-informed compensation models that reflect the realities of participation today.

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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:

1. Rebuild your review process – Think like Google’s AI. Test every ad for potential violations and ensure no ad slips through without rigorous scrutiny.
   
   
   
2. Avoid vague or risky language – No more overpromising or claims without solid regulatory backup. Be literal, clear, and backed by evidence.
   
   
   
3. Expect ad rejections – Budget for 10-20% fallout rate and build in time for appeals.
   
   
   
4. 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.

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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.

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