Accelerated Clinical Trial Agreement (ACTA)
The Accelerated Clinical Trial Agreement (ACTA) was prepared with the intent to facilitate relationships with industry sponsors who are interested in expediting the contract process, thus optimizing lag time for research.
The underlying principles used in the construction of the ACTA are that it represents a straightforward and unambiguous position that clearly sets forth the regulatory and contractual obligations of both parties and presents language that, while perhaps not ideal to either party, is acceptable to both. An Accelerated Confidential Disclosure Agreement (ACDA) has also been created as a companion document to the ACTA. Additional renditions of the ACTA (e.g., an ACTA for use with CROs) are also available on the following website.
The rationale behind the language used in ACTA is provided in the annotated ACTA.
See the language in the Accelerated Confidential Disclosure Agreement Template.
On June 28, 2019, the ACTA Working Group held an in-person meeting to review the most recent draft. A summary of the meeting can be found below. For more information on ACTA, click here.
Background on the ACTA & ACDA
How We Began
Contract negotiations are a complex process and are often identified as a major barrier to efficient study initiation. Data from a 2010 CTSA Contracts Processing study described an average negotiation time of 103 days, which was reduced to 73 days if a “master agreement” was utilized. As an attempt to remedy this hurdle, the CTSA Master Contracts Working Group, made up of legal experts from ~25 CTSA institutions, collaborated with industry and the University Industry Demonstration Partnership to develop a standardized clinical trial agreement – a single agreement to be used (voluntarily) by each participating institution and sponsor, to reduce contract negotiations for industry-sponsored multi-site studies, specifically for Phase 2b and Phase 3 Clinical Trials.
Where We Have Been
The ACTA was prepared with the intent to facilitate relationships with industry sponsors who are interested in expediting the contract process, thus optimizing lag time for research. The underlying principles used in the construction of the ACTA are that it represents a straightforward and unambiguous position that clearly sets forth the regulatory and contractual obligations of both parties and presents language that, while perhaps not ideal to either party, is acceptable to both.
Where We Are
The ACTA has now been reviewed by several external sources (Pfizer, Epizyme, Shire, Eli Lilly), and feedback has been incorporated. More than 50 organizations representing over 225 sites, including academic medical centers, universities, hospitals, and physician practices, have agreed that the terms would be acceptable.
