How It Began
Contract negotiations are a complex process and are often identified as a major barrier to efficient study initiation. Data from a 2010 CTSA sites contracts processing study (1) showed that an average contract terms negotiation time of 55 days could be reduced to 22 days if a ‘master agreement’ was used. 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.
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 which 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.
The ACTA has now been reviewed by several external sources (Pfizer, Epizyme, Shire) 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 50 organizations representing over 225 sites, including academic medical centers, universities, hospitals and physician practices, have agreed that the terms would be acceptable. Outreach has begun to approach Industry sponsors to initiate opportunities to pilot the use of the ACTA with 5 pilots currently active.