Blog

November 5, 2024

The Contract Network

Contracts for Cures: Streamlining Clinical Trial Agreements to Save Time and Lives

In the world of clinical trials, time is everything. Every day lost to administrative delay is a day longer that patients must wait for potential life-saving therapies. Yet despite this urgency, the average Clinical Trial Agreement (CTA) negotiation drags on for 64 days—a timeline that, given the stakes for all parties involved, is simply unacceptable.

Across conferences and industry panels, we hear the same call: sponsors and research sites alike want smoother, faster agreements. Sites and sponsors both express that they are eager to re-use the outcome from their last negotiations rather than starting from scratch with every new trial. And they express frustration about revisiting issues that they felt were resolved long ago. Both sides also say that if they could sit down or communicate “principal to principal,” many disputes would be settled in minutes.

And yet, when sponsors and sites discuss each other in isolation, the frustrations emerge. Sites see sponsors as out of touch with operational or regulatory requirements and insensitive to the burden of negotiating from elaborate sponsor-friendly templates. While sponsors view sites as lacking urgency or the resources to keep up.

The reality is that all sides are rational players, constrained by a system that hasn’t caught up with the modern demands of healthcare.

Curing the Contracting Process

To make real progress, we need to overhaul how we approach CTA negotiations. Here are five ways the industry can work together to cut through the inefficiencies and create a contracting process that supports—not hinders—timely clinical trials.

1. Re-Use Data and Prior Agreements

Contracts, especially in clinical trials, have a high degree of predictability. Parties tend to negotiate the same issues, resolve them in similar ways, and end up with agreements that look remarkably alike. Re-using past agreements or data from prior negotiations can save time, reduce negotiation rounds, and foster a sense of continuity across trials. Leveraging past contracts as templates not only accelerates the timeline but also minimizes legal costs and resources, allowing both sponsors and sites to focus on what truly matters: advancing medical research. We hear sponsors and sites alike say that they want to “start with the last agreement.” However, both parties often report that the other side is unwilling to take this approach.

2. Adopt Industry-Standard Templates (and modify them as necessary)

Sponsors often see custom agreements as more specific or advantageous, but they introduce significant complexity and resource burdens. By relying on widely accepted, industry-standard templates, sponsors and sites can establish a common ground from the start. This approach not only streamlines negotiations but also assures both parties that their interests are protected according to known, market-standard terms. When custom forms are necessary, parties should consider starting with an industry form and transparently adapting the template only where essential, instead of reinventing the wheel with each new trial.

3. Draft with Empathy

Many contract delays stem from avoidable misalignments. Sponsors can reduce friction by addressing known site concerns directly within initial drafts—rather than asking sites to revise language around known issues or previously accepted norms. Additionally, simple changes, such as using plain language, clear organization, and a collaborative tone, can preempt unnecessary back-and-forth. Drafting with empathy signals a respect for the resource constraints of sites and demonstrates a commitment to partnership rather than combat.

4. Educate on Market Standards

One of the most common causes of negotiation delay is misalignment on “market” terms. When both parties understand what is reasonable, standard, and widely accepted, negotiations are quicker, more focused, and less contentious. Education about what is typical in CTA terms can serve as a mutual reference point, helping to resolve disagreements and prevent unnecessary redlines.

5. Eliminate Workflow Challenges with Collaboration Tools

In resource-constrained and time-sensitive environments, the ability to streamline workflows is essential. With collaboration platforms, sponsors and sites can increase visibility, reduce miscommunication, and enable real-time adjustments to agreements. This not only eliminates bottlenecks but also allows both parties to engage more effectively, ensuring that time-sensitive issues are handled promptly and without unnecessary friction.

A Shared Commitment to Change

By treating clinical trial agreements as “Contracts for Cures,” we can shift the focus from negotiating points to delivering outcomes. Every tool we have at our disposal—from re-using templates to leveraging AI insights and collaboration platforms—should be directed at accelerating the contracting process. Sponsors and sites alike must recognize that the more time spent on these agreements, the more patients are left waiting.

Together, we can create a more efficient, empathetic, and rational approach to CTAs, one that prioritizes the urgency of healthcare over the inertia of traditional legal processes. When it comes to Contracts for Cures, it’s time to cure the contracting process itself.