The goal of this initiative has been to develop an efficient contract for sponsor-initiated multi-site trials. This streamlined process will allow sites to participate in clinical trials earlier in the process without undue delays in contract negotiations.
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 that 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 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. There has been considerable interest from regional collaborations (e.g., MARCH, PACT, Ohio) as well as other groups (e.g., WIRB/Copernicus Group and MAGI) in regards to advancing this initiative.
The ACTA is now ready for broad dissemination and adoption. More than 61 Institutions have agreed that the terms would be acceptable. Outreach has begun to approach Industry sponsors to identify the right opportunity to pilot the use of the agreement for a clinical trial in the next few months.
Register to use the ACTA here.