Accelerated Clinical Trial Agreement

Accelerated Clinical Trial Agreement: What You Need to Know

Clinical trials play a crucial role in the development of new drugs and treatments, but they can also be plagued by delays and inefficiencies. One way to speed up the process is through an accelerated clinical trial agreement (ACTA).

What is an ACTA?

An ACTA is a type of contract between a sponsor (usually a pharmaceutical company) and a clinical trial site. It outlines the terms and conditions of the trial, including the study protocol, financial compensation, and intellectual property rights. What sets an ACTA apart from a standard clinical trial agreement is the expedited timeline for negotiation and execution.

Why use an ACTA?

The traditional process of negotiating a clinical trial agreement can take several months or even years. This can delay the start of the trial and ultimately slow down the development and approval of new drugs. An ACTA streamlines the process by using pre-negotiated template language that has been vetted and approved by legal and regulatory authorities. This can reduce negotiation time to just a few weeks or days.

ACTAs also provide a more predictable and transparent financial model for all parties involved. They often include flat-rate, milestone-based, or pay-per-patient compensation structures, which can help sponsors budget more effectively and avoid unexpected costs.

Are there any downsides to using an ACTA?

Some critics argue that ACTAs reduce the bargaining power of clinical trial sites and may lead to less favorable terms for them. Additionally, because ACTAs are designed to be expedited, there may be less opportunity for site-specific customization or negotiation of certain terms.

However, many clinical trial sites see the benefits of using ACTAs and are willing to work within the framework. In fact, some sites have reported increased interest in participating in trials because they know the agreement process will be faster and more efficient.

How do you create an ACTA?

Creating an ACTA requires collaboration between the sponsor and the clinical trial site. The sponsor should have a pre-approved template agreement in place that complies with legal and regulatory requirements. The site should have a clear understanding of their capabilities and limitations, as well as their financial and legal requirements.

Once an agreement is reached, it should be reviewed and approved by legal and regulatory authorities before the trial can begin.

Conclusion

Accelerated clinical trial agreements offer a promising solution for speeding up the drug development process. While there may be some downsides to using an ACTA, the benefits of reduced negotiation time and more predictable financial models are hard to ignore. As more sponsors and clinical trial sites adopt this approach, we can expect to see faster and more efficient clinical trials in the future.